Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00617604
Recruitment Status : Completed
First Posted : February 18, 2008
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition De Novo Kidney Transplantation
Interventions Drug: Alefacept
Drug: placebo
Drug: Tacrolimus
Drug: Mycophenolate Mofetil
Drug: Steroids
Enrollment 218
Recruitment Details Of 221 patients screened, 218 patients were enrolled into the study at 30 centers across 12 countries.
Pre-assignment Details  
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Period Title: Overall Study
Started 110 108
Received Treatment 107 105
Completed 12 Weeks of Treatment 89 83
Completed 92 [1] 88 [1]
Not Completed 18 20
Reason Not Completed
Death             2             1
Lost to Follow-up             1             0
Miscellaneous Reasons             8             10
Withdrawal by Subject             4             6
Randomized but Never Received Study Drug             3             3
[1]
Completed Month 6 assessment
Arm/Group Title Placebo Alefacept Total
Hide Arm/Group Description Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment. Total of all reporting groups
Overall Number of Baseline Participants 107 105 212
Hide Baseline Analysis Population Description
All randomized patients who took at least 1 dose of study drug (Safety Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 105 participants 212 participants
46.5  (11.3) 44.2  (11.9) 45.4  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 105 participants 212 participants
Female
33
  30.8%
40
  38.1%
73
  34.4%
Male
74
  69.2%
65
  61.9%
139
  65.6%
1.Primary Outcome
Title Percentage of Participants With Biopsy-confirmed Acute T-cell Mediated Rejection at Month 6 Assessed by Local Review
Hide Description

Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:

  • Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;
  • Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;
  • Grade IIA: mild to moderate intimal arteritis;
  • Grade IIB: severe intimal arteritis comprising >25% of the luminal area;
  • Grade III: "transmural" arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.

A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.

The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (all randomized and transplanted participants who received at least 1 dose of study drug)
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
6.7
(2.7 to 10.7)
10.6
(5.6 to 15.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 3.9
Confidence Interval (2-Sided) 90%
-2.5 to 10.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Biopsy Confirmed Antibody-Mediated Acute Rejection at Month 6
Hide Description

Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification:

Acute antibody-mediated rejection - documented anti-donor antibody (‘suspicious for’ if antibody not demonstrated):

  • Grade I: acute tubular necrosis-like - complement split product positive (C4d+), minimal inflammation;
  • Grade II: capillary-margination and/or thromboses, C4d+
  • Grade III: arterial - v3, C4d+.

A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.

The Kaplan-Meier estimate of biopsy-confirmed antibody-mediated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
2.9
(0.2 to 5.5)
3.8
(0.7 to 6.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 1.0
Confidence Interval (2-Sided) 90%
-3.1 to 5.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Biopsy Confirmed Acute Rejection (T-Cell Mediated or Antibody Mediated) at Month 6
Hide Description

Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.

The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated or antibody-mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
9.3
(4.7 to 14.0)
12.4
(7.1 to 17.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 3.0
Confidence Interval (2-Sided) 90%
-4.0 to 10.1
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Biopsy Confirmed Acute Mixed T-Cell Mediated and Antibody-Mediated Rejection at Month 6
Hide Description

Biopsies were graded by the clinical site pathologist.according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.

The Kaplan-Meier estimate of biopsy-confirmed acute mixed T-cell mediated and antibody-mediated rejections within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 0.0)
1.0
(0.0 to 2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 1.0
Confidence Interval (2-Sided) 90%
-0.6 to 2.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Acute Rejection Diagnosed by Signs and Symptoms at Month 6
Hide Description Acute rejection diagnosed by signs and symptoms, including biopsy-confirmed or suspected (not confirmed by biopsy - i.e. no biopsy was performed or biopsy did not confirm an acute T-cell mediated rejection). The Kaplan-Meier estimate of acute rejection diagnosed by signs and symptoms within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
27.4
(20.3 to 34.6)
22.3
(15.6 to 29.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -5.1
Confidence Interval (2-Sided) 90%
-14.9 to 4.7
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With Clinically Treated Acute Rejection at Month 6
Hide Description Patients who received immunosuppressive medications for the treatment of suspected or biopsy-confirmed acute rejections were considered to have a clinically-treated acute rejection. The Kaplan-Meier estimate of clinically treated acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
24.8
(17.9 to 31.7)
15.4
(9.6 to 21.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -9.4
Confidence Interval (2-Sided) 90%
-18.5 to 0.0
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Participants With Steroid-resistant Acute Rejection at Month 6
Hide Description

A steroid-resistant acute rejection is defined as a rejection episode which did not resolve following treatment with corticosteroids. In the case that a rejection episode was not treated with corticosteroids first but only with antibodies, it was included in this category.

The Kaplan-Meier estimate of steroid-resistant acute rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
7.6
(3.4 to 11.9)
5.7
(2.0 to 9.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.9
Confidence Interval (2-Sided) 90%
-7.6 to 3.8
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Participants With Biopsy-Confirmed Acute T-cell Mediated Rejection as Assessed by Central Review at Month 6
Hide Description

Biopsies were graded by the central reviewer according to the Banff 97/05 updated histological classification. A biopsy confirmed acute rejection was an event of suspected acute rejection confirmed by a graft biopsy result of Banff grade ≥ 1.

The Kaplan-Meier estimate of biopsy-confirmed acute T-cell mediated rejection within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow up visit.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
9.6
(4.8 to 14.3)
7.7
(3.4 to 12.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -1.8
Confidence Interval (2-Sided) 90%
-8.2 to 4.6
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Patient Survival
Hide Description Patient survival is any participant known to be alive at Month 6. The Kaplan-Meier estimate of patient survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
97.1
(94.4 to 99.8)
99.0
(97.3 to 100.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 1.9
Confidence Interval (2-Sided) 90%
-1.3 to 5.0
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Graft Survival
Hide Description

Graft survival was defined as any participant who was known to have a functioning graft (i.e., not graft loss) at 6 months. Graft loss is defined as re-transplantation, nephrectomy, death or as dialysis ongoing at end of study or at discontinuation of the participant unless superseded by follow-up information.

The Kaplan-Meier estimate of graft survival within the first 6 months following transplantation is reported. Participants lost to follow-up were censored at the time of last assessment.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
90.6
(86.0 to 95.3)
95.2
(91.7 to 98.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 4.6
Confidence Interval (2-Sided) 90%
-1.2 to 10.4
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Maximum Histological Grade of All Biopsies After Local Review
Hide Description

The grade of acute rejection was classified according to Banff 97/05 updated version. If a patient had more than 1 rejection episode, the episode with the most severe grade was used.

Acute T-cell mediated rejection:

  • Grade IA: significant interstitial infiltration (>25% parenchyma affected) and foci of moderate tubulitis;
  • Grade IB: significant interstitial infiltration (>25% parenchyma affected) and foci of severe tubulitis;
  • Grade IIA: mild to moderate intimal arteritis;
  • Grade IIB: severe intimal arteritis comprising >25% of the luminal area;
  • Grade III: “transmural” arteritis and/or arterial fibrinoid change and necrosis of medial smooth muscle cells with accompanying lymphocyte inflammation.

Acute antibody-mediated rejection:

  • Grade I: acute tubular necrosis-like – complement split product positive (C4d+), minimal inflammation;
  • Grade II: capillary-margination and/or thromboses, C4d+
  • Grade III: arterial – v3, C4d+.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Unit of Measure: percentage of participants
T-Cell Mediated Rejection - No Event 93.5 89.5
T-Cell Mediated Rejection - Grade IA 2.8 1.9
T-Cell Mediated Rejection - Grade IB 0.0 1.0
T-Cell Mediated Rejection - Grade IIA 1.9 4.8
T-Cell Mediated Rejection - Grade IIB 1.9 2.9
T-Cell Mediated Rejection - Grade III 0.0 0.0
Antibody Mediated Rejection - No Event 97.2 96.2
Antibody Mediated Rejection - Grade I 2.8 1.9
Antibody Mediated Rejection - Grade II 0.0 1.9
Antibody Mediated Rejection - Grade III 0.0 0.0
12.Secondary Outcome
Title Percentage of Participants With Anti-Lymphocyte Antibody Therapy for Treatment of Rejection at Month 6
Hide Description The Kaplan-Meier estimate of anti-lymphocyte antibody therapy for acute rejection (clinically-treated or biopsy-confirmed) within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
4.7
(1.3 to 8.2)
6.7
(2.7 to 10.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 2.0
Confidence Interval (2-Sided) 90%
-3.3 to 7.2
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Month 1 in Serum Creatinine
Hide Description [Not Specified]
Time Frame Month 1, 3, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set participants with available data at Month 1 (99 and 94 participants in each treatment group respectively) and at Month 3 and Month 6 (indicated by "n").
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 99 94
Mean (Standard Deviation)
Unit of Measure: µmol/L
Change From Month 1 to Month 3 (n=94, 88) -5.0125  (37.97017) -5.0830  (66.25416)
Change From Month 1 to Month 6 (n=86, 81) -6.1777  (41.57056) -11.7212  (76.19852)
14.Secondary Outcome
Title Change From Month 1 in Glomerular Filtration Rate (GFR)
Hide Description The GFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.
Time Frame Month 1, 3, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set participants with available data at Month 1 (98, 93 participants respectively) and at Month 3 and Month 6 (indicated by "n").
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 98 93
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73 m²
Change From Month 1 to Month 3 (n=93, 87) 3.1548  (13.59730) 0.2889  (12.54716)
Change From Month 1 to Month 6 (n=83, 78) 2.4275  (15.79533) 2.5444  (13.06726)
15.Secondary Outcome
Title Change From Month 1 in Creatinine Clearance
Hide Description The creatinine clearance was calculated according to the Cockcroft-Gault formula.
Time Frame Month 1, 3, and 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set participants with available data at Month 1 (90, 84) and at Month 3 and Month 6 (indicated by "n").
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 90 84
Mean (Standard Deviation)
Unit of Measure: mL/minute
Change From Month 1 to Month 3 (n=81, 79) 3.0336  (13.97651) -0.5849  (12.95160)
Change From Month 1 to Month 6 (n=77, 73) 4.5388  (17.56456) 3.0227  (13.25005)
16.Secondary Outcome
Title GFR Measured by Iothalamate Clearance at Month 6
Hide Description GFR measured using the iothalamate clearance method and determined by a central laboratory.
Time Frame Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set participants with available data
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 68 62
Mean (Standard Deviation)
Unit of Measure: mL/minute
59.6029  (31.36836) 55.1613  (26.46383)
17.Secondary Outcome
Title Percentage of Participants With Efficacy Failure at Month 6
Hide Description

Efficacy failure is defined as death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading or lost to follow-up.

The Kaplan-Meier estimate of efficacy failure within the first 6 months following transplantation is reported.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
15.0
(9.3 to 20.6)
21.0
(14.4 to 27.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value 6.0
Confidence Interval (2-Sided) 90%
-2.7 to 14.6
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants With Delayed Graft Function
Hide Description Delayed graft function was defined as the requirement for dialysis within the first week post-transplant.
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Unit of Measure: percentage of participants
12.1 7.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -4.5
Confidence Interval (2-Sided) 90%
-11.2 to 2.2
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants With Treatment Failure at Month 6
Hide Description Treatment failure is defined as efficacy failure (death, graft loss, biopsy-confirmed acute T-cell mediated rejection assessed by local reading, lost to follow-up) or early discontinuation of alefacept/placebo at any time (during the 12-week administration period) for any reason. The Kaplan-Meier estimate of treatment failure within the first 6 months following transplantation is reported. Participants lost to follow-up or with missing outcomes were censored at their last follow-up visit.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
20.6
(14.1 to 27.0)
25.7
(18.7 to 32.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Alefacept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 5.2
Confidence Interval (2-Sided) 90%
-4.4 to 14.7
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

Causally related was defined as adverse events (AEs) assessed by the Investigator as possibly or probably related to study drug or records where the relationship was missing.

A serious adverse event (SAE) was any untoward medical occurrence that, at any dose:

  • Resulted in death.
  • Was life-threatening.
  • Resulted in persistent or significant disability/incapacity.
  • Resulted in congenital anomaly or birth defect.
  • Required patient hospitalization or led to prolongation of hospitalization
  • Was considered a medically important event.

All rejections and any BK virus, Epstein Barr virus and/or cytomegalovirus infection had to be reported as an SAE

Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (all randomized participants who received at least one dose of study drug).
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description:
Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
Overall Number of Participants Analyzed 107 105
Measure Type: Number
Unit of Measure: participants
Any adverse event 102 101
AE causally related to alefacept/placebo 36 41
AE causally related to MMF 56 56
AE causally related to tacrolimus 49 49
AE causally related to steroids 46 46
Serious adverse events 62 57
SAE causally related to alefacept/placebo 19 16
SAE causally related to MMF 19 21
SAE causally related to tacrolimus 14 20
SAE causally related to steroids 11 15
AE leading to discontinuation of alefacept/placebo 7 10
AE leading to discontinuation of MMF 8 6
AE leading to discontinuation of tacrolimus 8 3
AE leading to discontinuation of steroids 1 2
Deaths 3 1
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Alefacept
Hide Arm/Group Description Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment. Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
All-Cause Mortality
Placebo Alefacept
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Alefacept
Affected / at Risk (%) Affected / at Risk (%)
Total   62/107 (57.94%)   57/105 (54.29%) 
Blood and lymphatic system disorders     
Leukopenia  1  1/107 (0.93%)  1/105 (0.95%) 
Anaemia  1  0/107 (0.00%)  1/105 (0.95%) 
Leukocytosis  1  0/107 (0.00%)  1/105 (0.95%) 
Pancytopenia  1  0/107 (0.00%)  1/105 (0.95%) 
Thrombocytopenia  1  0/107 (0.00%)  1/105 (0.95%) 
Neutropenia  1  1/107 (0.93%)  0/105 (0.00%) 
Cardiac disorders     
Myocardial infarction  1  1/107 (0.93%)  1/105 (0.95%) 
Acute myocardial infarction  1  1/107 (0.93%)  0/105 (0.00%) 
Angina pectoris  1  1/107 (0.93%)  0/105 (0.00%) 
Endocrine disorders     
Adrenal insufficiency  1  0/107 (0.00%)  1/105 (0.95%) 
Hyperparathyroidism  1  0/107 (0.00%)  1/105 (0.95%) 
Hyperparathyroidism tertiary  1  0/107 (0.00%)  1/105 (0.95%) 
Gastrointestinal disorders     
Diarrhoea  1  2/107 (1.87%)  4/105 (3.81%) 
Diverticulum intestinal  1  0/107 (0.00%)  1/105 (0.95%) 
Duodenogastric reflux  1  0/107 (0.00%)  1/105 (0.95%) 
Peritonitis  1  0/107 (0.00%)  1/105 (0.95%) 
Abdominal pain upper  1  2/107 (1.87%)  0/105 (0.00%) 
Gastrointestinal haemorrhage  1  1/107 (0.93%)  0/105 (0.00%) 
Haemorrhoids  1  1/107 (0.93%)  0/105 (0.00%) 
Periodontitis  1  1/107 (0.93%)  0/105 (0.00%) 
General disorders     
Pyrexia  1  2/107 (1.87%)  1/105 (0.95%) 
Oedema peripheral  1  0/107 (0.00%)  1/105 (0.95%) 
Chest pain  1  2/107 (1.87%)  0/105 (0.00%) 
Drug intolerance  1  1/107 (0.93%)  0/105 (0.00%) 
Face oedema  1  1/107 (0.93%)  0/105 (0.00%) 
Generalised oedema  1  1/107 (0.93%)  0/105 (0.00%) 
Infections and infestations     
Cytomegalovirus infection  1  6/107 (5.61%)  9/105 (8.57%) 
Pyelonephritis  1  0/107 (0.00%)  4/105 (3.81%) 
Bk virus infection  1  8/107 (7.48%)  3/105 (2.86%) 
Urinary tract infection  1  6/107 (5.61%)  2/105 (1.90%) 
Pyelonephritis acute  1  2/107 (1.87%)  1/105 (0.95%) 
Urosepsis  1  2/107 (1.87%)  1/105 (0.95%) 
Cytomegalovirus viraemia  1  1/107 (0.93%)  1/105 (0.95%) 
Bacteraemia  1  0/107 (0.00%)  1/105 (0.95%) 
Epstein-barr virus infection  1  0/107 (0.00%)  1/105 (0.95%) 
Herpes zoster  1  0/107 (0.00%)  1/105 (0.95%) 
Orchitis  1  0/107 (0.00%)  1/105 (0.95%) 
Renal abscess  1  0/107 (0.00%)  1/105 (0.95%) 
Wound abscess  1  0/107 (0.00%)  1/105 (0.95%) 
Wound infection  1  0/107 (0.00%)  1/105 (0.95%) 
Polyomavirus-associated nephropathy  1  2/107 (1.87%)  0/105 (0.00%) 
Septic shock  1  2/107 (1.87%)  0/105 (0.00%) 
Arteriovenous fistula site infection  1  1/107 (0.93%)  0/105 (0.00%) 
Erythema infectiosum  1  1/107 (0.93%)  0/105 (0.00%) 
Kidney infection  1  1/107 (0.93%)  0/105 (0.00%) 
Mastitis  1  1/107 (0.93%)  0/105 (0.00%) 
Pneumonia  1  1/107 (0.93%)  0/105 (0.00%) 
Pneumonia bacterial  1  1/107 (0.93%)  0/105 (0.00%) 
Renal cyst infection  1  1/107 (0.93%)  0/105 (0.00%) 
Sepsis  1  1/107 (0.93%)  0/105 (0.00%) 
Tuberculosis  1  1/107 (0.93%)  0/105 (0.00%) 
Upper respiratory tract infection  1  1/107 (0.93%)  0/105 (0.00%) 
Injury, poisoning and procedural complications     
Complications of transplanted kidney  1  8/107 (7.48%)  8/105 (7.62%) 
Chronic allograft nephropathy  1  0/107 (0.00%)  1/105 (0.95%) 
Drug toxicity  1  0/107 (0.00%)  1/105 (0.95%) 
Graft loss  1  0/107 (0.00%)  1/105 (0.95%) 
Post procedural haemorrhage  1  0/107 (0.00%)  1/105 (0.95%) 
Postoperative hernia  1  0/107 (0.00%)  1/105 (0.95%) 
Rib fracture  1  0/107 (0.00%)  1/105 (0.95%) 
Thrombosis in device  1  0/107 (0.00%)  1/105 (0.95%) 
Graft dysfunction  1  4/107 (3.74%)  0/105 (0.00%) 
Transplant failure  1  2/107 (1.87%)  0/105 (0.00%) 
Arteriovenous graft thrombosis  1  1/107 (0.93%)  0/105 (0.00%) 
Perinephric collection  1  1/107 (0.93%)  0/105 (0.00%) 
Perirenal haematoma  1  1/107 (0.93%)  0/105 (0.00%) 
Urinary anastomotic leak  1  1/107 (0.93%)  0/105 (0.00%) 
Investigations     
Histology abnormal  1  11/107 (10.28%)  6/105 (5.71%) 
Blood creatinine increased  1  4/107 (3.74%)  1/105 (0.95%) 
C-reactive protein increased  1  0/107 (0.00%)  1/105 (0.95%) 
Blood creatine increased  1  1/107 (0.93%)  0/105 (0.00%) 
Haematocrit decreased  1  1/107 (0.93%)  0/105 (0.00%) 
Weight decreased  1  1/107 (0.93%)  0/105 (0.00%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  1/107 (0.93%)  1/105 (0.95%) 
Diabetes mellitus inadequate control  1  0/107 (0.00%)  1/105 (0.95%) 
Hypercalcaemia  1  0/107 (0.00%)  1/105 (0.95%) 
Hypoglycaemia  1  1/107 (0.93%)  0/105 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/107 (0.93%)  0/105 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/107 (0.00%)  1/105 (0.95%) 
Cervix carcinoma  1  0/107 (0.00%)  1/105 (0.95%) 
Lung neoplasm malignant  1  0/107 (0.00%)  1/105 (0.95%) 
Phaeochromocytoma malignant  1  0/107 (0.00%)  1/105 (0.95%) 
Post transplant lymphoproliferative disorder  1  0/107 (0.00%)  1/105 (0.95%) 
Renal neoplasm  1  0/107 (0.00%)  1/105 (0.95%) 
Colon cancer  1  1/107 (0.93%)  0/105 (0.00%) 
Metastases to liver  1  1/107 (0.93%)  0/105 (0.00%) 
Nervous system disorders     
Reversible posterior leukoencephalopathy syndrome  1  0/107 (0.00%)  1/105 (0.95%) 
Psychiatric disorders     
Mental disorder  1  1/107 (0.93%)  0/105 (0.00%) 
Renal and urinary disorders     
Renal impairment  1  8/107 (7.48%)  4/105 (3.81%) 
Renal failure acute  1  1/107 (0.93%)  4/105 (3.81%) 
Hydronephrosis  1  0/107 (0.00%)  4/105 (3.81%) 
Renal artery stenosis  1  3/107 (2.80%)  1/105 (0.95%) 
Renal haemorrhage  1  1/107 (0.93%)  1/105 (0.95%) 
Renal tubular necrosis  1  1/107 (0.93%)  1/105 (0.95%) 
Ureteric stenosis  1  1/107 (0.93%)  1/105 (0.95%) 
Microalbuminuria  1  0/107 (0.00%)  1/105 (0.95%) 
Nephropathy toxic  1  0/107 (0.00%)  1/105 (0.95%) 
Proteinuria  1  0/107 (0.00%)  1/105 (0.95%) 
Renal ischaemia  1  0/107 (0.00%)  1/105 (0.95%) 
Focal segmental glomerulosclerosis  1  1/107 (0.93%)  0/105 (0.00%) 
Renal vein thrombosis  1  1/107 (0.93%)  0/105 (0.00%) 
Urinary tract obstruction  1  1/107 (0.93%)  0/105 (0.00%) 
Reproductive system and breast disorders     
Epididymitis  1  1/107 (0.93%)  0/105 (0.00%) 
Prostatitis  1  1/107 (0.93%)  0/105 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1  1/107 (0.93%)  1/105 (0.95%) 
Acute pulmonary oedema  1  1/107 (0.93%)  0/105 (0.00%) 
Pleurisy  1  1/107 (0.93%)  0/105 (0.00%) 
Surgical and medical procedures     
Tooth extraction  1  1/107 (0.93%)  0/105 (0.00%) 
Vascular disorders     
Lymphocele  1  2/107 (1.87%)  1/105 (0.95%) 
Circulatory collapse  1  0/107 (0.00%)  1/105 (0.95%) 
Thrombophlebitis superficial  1  0/107 (0.00%)  1/105 (0.95%) 
Deep vein thrombosis  1  1/107 (0.93%)  0/105 (0.00%) 
Haematoma  1  1/107 (0.93%)  0/105 (0.00%) 
Iliac artery stenosis  1  1/107 (0.93%)  0/105 (0.00%) 
Peripheral ischaemia  1  1/107 (0.93%)  0/105 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Alefacept
Affected / at Risk (%) Affected / at Risk (%)
Total   98/107 (91.59%)   92/105 (87.62%) 
Blood and lymphatic system disorders     
Anaemia  1  54/107 (50.47%)  42/105 (40.00%) 
Leukopenia  1  15/107 (14.02%)  14/105 (13.33%) 
Thrombocytopenia  1  7/107 (6.54%)  5/105 (4.76%) 
Cardiac disorders     
Tachycardia  1  1/107 (0.93%)  6/105 (5.71%) 
Gastrointestinal disorders     
Abdominal pain  1  4/107 (3.74%)  7/105 (6.67%) 
Abdominal pain upper  1  3/107 (2.80%)  8/105 (7.62%) 
Constipation  1  20/107 (18.69%)  19/105 (18.10%) 
Diarrhoea  1  29/107 (27.10%)  25/105 (23.81%) 
Nausea  1  7/107 (6.54%)  10/105 (9.52%) 
Vomiting  1  7/107 (6.54%)  8/105 (7.62%) 
General disorders     
Oedema peripheral  1  14/107 (13.08%)  9/105 (8.57%) 
Pyrexia  1  9/107 (8.41%)  9/105 (8.57%) 
Infections and infestations     
Urinary tract infection  1  25/107 (23.36%)  26/105 (24.76%) 
Injury, poisoning and procedural complications     
Complications of transplanted kidney  1  12/107 (11.21%)  10/105 (9.52%) 
Procedural pain  1  6/107 (5.61%)  3/105 (2.86%) 
Investigations     
Blood creatinine increased  1  8/107 (7.48%)  10/105 (9.52%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  13/107 (12.15%)  13/105 (12.38%) 
Hypercholesterolaemia  1  7/107 (6.54%)  4/105 (3.81%) 
Hyperglycaemia  1  14/107 (13.08%)  17/105 (16.19%) 
Hyperkalaemia  1  10/107 (9.35%)  10/105 (9.52%) 
Hyperlipidaemia  1  7/107 (6.54%)  6/105 (5.71%) 
Hyperuricaemia  1  7/107 (6.54%)  5/105 (4.76%) 
Hypocalcaemia  1  7/107 (6.54%)  6/105 (5.71%) 
Hypokalaemia  1  17/107 (15.89%)  15/105 (14.29%) 
Hypomagnesaemia  1  6/107 (5.61%)  7/105 (6.67%) 
Hypophosphataemia  1  8/107 (7.48%)  2/105 (1.90%) 
Nervous system disorders     
Headache  1  4/107 (3.74%)  7/105 (6.67%) 
Tremor  1  8/107 (7.48%)  16/105 (15.24%) 
Psychiatric disorders     
Anxiety  1  7/107 (6.54%)  4/105 (3.81%) 
Insomnia  1  12/107 (11.21%)  11/105 (10.48%) 
Renal and urinary disorders     
Dysuria  1  7/107 (6.54%)  4/105 (3.81%) 
Renal impairment  1  8/107 (7.48%)  9/105 (8.57%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  6/107 (5.61%)  4/105 (3.81%) 
Vascular disorders     
Hypertension  1  19/107 (17.76%)  25/105 (23.81%) 
Lymphocele  1  8/107 (7.48%)  2/105 (1.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data or 12 months after data-lock, whichever is first. Sponsor must receive a site’s manuscript at least 30 days prior to publication for review and comment. Sponsor may delay the publication temporarily to seek patent protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director Medical Science
Organization: Astellas Pharma Europe B.V
EMail: Astellas.resultsdisclosure@astellas.com
Layout table for additonal information
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00617604     History of Changes
Other Study ID Numbers: 0485-CL-E201
2007-002092-14 ( EudraCT Number )
First Submitted: February 6, 2008
First Posted: February 18, 2008
Results First Submitted: January 5, 2016
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016