Trial record 1 of 1 for:    NCT00543569
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A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00543569
First received: October 11, 2007
Last updated: November 6, 2015
Last verified: November 2015
Results First Received: November 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Kidney Transplantation
Interventions: Drug: Alefacept
Drug: tacrolimus
Drug: basiliximab
Drug: mycophenolate mofetil
Drug: Corticosteroids

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study enrolled de novo kidney transplant recipients who were at least 18 years of age.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tacrolimus/MMF/Basiliximab Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
Alefacept QW/Tacrolimus/MMF Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
Alefacept QW/Tacrolimus Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
Alefacept QOW/Tacrolimus/MMF Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.

Participant Flow:   Overall Study
    Tacrolimus/MMF/Basiliximab     Alefacept QW/Tacrolimus/MMF     Alefacept QW/Tacrolimus     Alefacept QOW/Tacrolimus/MMF  
STARTED     82     80     80     81  
Received Treatment     79     77     75     78  
COMPLETED     70     72     60     72  
NOT COMPLETED     12     8     20     9  
Death                 2                 2                 3                 1  
Lost to Follow-up                 0                 0                 1                 1  
Miscellaneous Reasons                 7                 3                 11                 4  
Randomized but never received study drug                 3                 3                 5                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Tacrolimus/MMF/Basiliximab Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
Alefacept QW/Tacrolimus/MMF Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
Alefacept QW/Tacrolimus Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
Alefacept QOW/Tacrolimus/MMF Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
Total Total of all reporting groups

Baseline Measures
    Tacrolimus/MMF/Basiliximab     Alefacept QW/Tacrolimus/MMF     Alefacept QW/Tacrolimus     Alefacept QOW/Tacrolimus/MMF     Total  
Number of Participants  
[units: participants]
  79     77     75     78     309  
Age  
[units: years]
Mean (Standard Deviation)
  48.44  (15.077)     49.26  (13.532)     47.80  (12.469)     49.68  (13.749)     48.80  (13.707)  
Gender  
[units: participants]
         
Female     28     20     27     24     99  
Male     51     57     48     54     210  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Biopsy-confirmed Acute Rejection (BCAR) at Month 6 Assessed by Local Review   [ Time Frame: 6 months ]

2.  Secondary:   Patient Survival at Month 6 and Month 12   [ Time Frame: 6 months and 12 months ]

3.  Secondary:   Graft Survival at Month 6 and Month 12   [ Time Frame: 6 months and 12 months ]

4.  Secondary:   Percentage of Participants With BCAR at Month 12 Assessed by Local Review   [ Time Frame: 12 months ]

5.  Secondary:   Percentage of Participants With BCAR at Month 6 and 12 Assessed by Central Review   [ Time Frame: 6 months and 12 months ]

6.  Secondary:   Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Local Review   [ Time Frame: 6 months and 12 months ]

7.  Secondary:   Percentage of Participants With T-cell Mediated BCAR at Month 6 and 12 Assessed by Central Review   [ Time Frame: 6 months and 12 months ]

8.  Secondary:   Change From Week 4 in Glomerular Filtration Rate Estimated by the MDRD Method at Month 6 and Month 12   [ Time Frame: Week 4, Month 6 and Month 12 ]

9.  Secondary:   Change From Week 4 in GFR by Iothalamate Clearance at Month 6   [ Time Frame: Week 4 and Month 6 ]

10.  Secondary:   Change From Week 4 in Serum Creatinine at Month 6 and 12   [ Time Frame: Week 4 and Month 6 and 12 ]

11.  Secondary:   Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Local Review   [ Time Frame: 6 months and 12 months ]

12.  Secondary:   Percentage of Participants With Efficacy Failure at 6 and 12 Months Assessed by Central Review   [ Time Frame: 6 months and 12 months ]

13.  Secondary:   Time to First BCAR Assessed by Local Review   [ Time Frame: 12 months ]

14.  Secondary:   Time to First BCAR Assessed by Central Review   [ Time Frame: 12 months ]

15.  Secondary:   Time to First T-cell Mediated BCAR Assessed by Local Review   [ Time Frame: 12 months ]

16.  Secondary:   Time to First T-cell Mediated BCAR Assessed by Central Review   [ Time Frame: 12 months ]

17.  Secondary:   Maximum Grade of T-cell Mediated Rejection Assessed by Local Review   [ Time Frame: 6 months and 12 months ]

18.  Secondary:   Maximum Grade of T-cell Mediated Rejection as Assessed by Central Review   [ Time Frame: 6 months and 12 months ]

19.  Secondary:   Percentage of Participants With Clinically Treated Acute Rejection at Month 6 and Month 12   [ Time Frame: 6 months and 12 months ]

20.  Secondary:   Percentage of Participants With Anti-lymphocyte-treated Rejection at Months 6 and 12   [ Time Frame: 6 months and 12 months ]

21.  Secondary:   Percentage of Participants With Multiple Rejection Episodes at Months 6 and 12   [ Time Frame: 6 months and 12 months ]

22.  Secondary:   Percentage of Participants With Treatment Failure at Month 6 and 12   [ Time Frame: 6 months and 12 months ]

23.  Secondary:   Gastrointestinal Quality of Life Index Score Over Time   [ Time Frame: Months 1, 3, 6, and 12 ]

24.  Secondary:   Gastrointestinal Symptom Rating Scale Scores Over Time   [ Time Frame: Months 1, 3, 6, and 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Head Global Medical Sciences--Transplant and Immunology/Inflammation
Organization: Astellas Pharma Global Development, Inc. (APGD)
e-mail: Astellas.resultsdisclosure@astellas.com



Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00543569     History of Changes
Other Study ID Numbers: 0485-CL-U201
Study First Received: October 11, 2007
Results First Received: November 6, 2015
Last Updated: November 6, 2015
Health Authority: United States: Food and Drug Administration