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Belatacept to Prevent Organ Rejection in Kidney Transplant Patients (BESTT)

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: NCT00346151
Recruitment Status : Terminated (Stopping rule-acute rejection threshold-was met based on local biopsy results)
First Posted : June 29, 2006
Results First Posted : November 7, 2011
Last Update Posted : April 21, 2017
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Transplant
Interventions Drug: Belatacept
Drug: Sirolimus
Drug: Anti-thymocyte globulin
Drug: methylprednisolone
Enrollment 5
Recruitment Details Two centers in the United States enrolled five recipients of non-human leukocyte antigen (HLA)-identical living-donor-related renal transplants between January 2007 and January 2009.
Pre-assignment Details At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and sign the informed consent form.
Arm/Group Title Belatacept
Hide Arm/Group Description Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
Period Title: Overall Study
Started 5
Completed 2
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
50.4  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Acute Rejection at 6-Months
Hide Description

Cumulative incidence of acute rejection[1] at 6 months post-transplant based on local pathology biopsy reads

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999
Time Frame 6 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion of participant's cumulative incidence of acute rejection at 24 weeks with 95% exact binomial confidence interval. Local biopsy reads were used in determining primary endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate
Estimated Value 60
Confidence Interval 95%
15 to 95
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Participant Survival at 12 Months Post-Transplant
Hide Description [Not Specified]
Time Frame 12 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Sample participants not terminating prior to 12 months.
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Participants
4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion with 95% exact binomial confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate
Estimated Value 100
Confidence Interval 95%
40 to 100
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Acute Rejection at 12-Months
Hide Description

Incidence of acute rejection[1] at 12 months post-transplant

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999
Time Frame 12 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Sample
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion with 95% exact binomial confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence rate
Estimated Value 80
Confidence Interval 95%
28 to 99
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Tolerance Induction
Hide Description Time from transplantation to initiation of sirolimus withdrawal.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat sample that initiated sirolimus withdrawal
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: Days
391
5.Secondary Outcome
Title Renal Function as Measured by Glomerular Filtration Rate (GFR) at 24 Weeks
Hide Description

GFR utilizing clearance of iothalamate.

GFR is an index of level of kidney function. A higher value means better kidney function.

Time Frame 24 weeks post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Sample
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73m^2
62.0  (8.5)
6.Secondary Outcome
Title Graft Survival at 12 Months Post-transplant
Hide Description [Not Specified]
Time Frame 12 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat sample participants not terminating prior to 12 months
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: Participants
4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion with 95% exact binomial confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate
Estimated Value 100
Confidence Interval 95%
40 to 100
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Time From Transplant to Acute Rejection
Hide Description

Time (days) from transplant to occurrence of acute rejection[1]

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999
Time Frame Transplantation until rejection occurs (participants followed up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat sample participants with rejection
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: Days
15
(1 to 200)
8.Secondary Outcome
Title Proportion of Participants Requiring Antilymphocyte Therapy for Acute Rejection
Hide Description

Proportion of participants who experienced acute rejection[1] requiring antilymphocyte therapy

  1. Diagnosis of acute rejection was made by renal (kidney) biopsy using the Banff 97 criteria. The Banff 97 diagnostic category for renal allograft biopsies is an international standardized histopathological classification. Acute rejection is defined by a renal biopsy demonstrating a Banff 97 classification of Grade IA or greater[2]
  2. Reference: Racusen LC, Solez K, Colvin RB et al,The Banff 97 working classification of renal allograft pathology. Kidney Int,55: 713–723, 1999
Time Frame Participants followed from transplantation until completion of study (up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Sample
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion with 95% exact binomial confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate
Estimated Value 0
Confidence Interval 95%
0 to 52.2
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Proportion of Participants With Post-transplant Infections
Hide Description Proportion of participants who experienced infections post-transplant. Participants were checked for any type of opportunistic infection at all study visits post-transplantation (up to 4 years post-transplantation)
Time Frame Participants followed from transplantation until completion of study (up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Sample
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion with 95% exact binomial confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate
Estimated Value 80
Confidence Interval 95%
28 to 99
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Proportion of Participants With Wound Complications
Hide Description [Not Specified]
Time Frame Start of study to end of study
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Sample
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion with 95% exact binomial confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate
Estimated Value 0
Confidence Interval 95%
0 to 52.2
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Proportion of Participants With Malignancies
Hide Description [Not Specified]
Time Frame Participants followed from transplantation until completion of study (up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Sample
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion with 95% exact binomial confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate
Estimated Value 0
Confidence Interval 95%
0 to 52.2
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Proportion of Participants With a Sirolimus Associated Adverse Event
Hide Description [Not Specified]
Time Frame Participants followed from transplantation until completion of study (up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Sample
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion with 95% exact binomial confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate
Estimated Value 100
Confidence Interval 95%
47.8 to 100
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Proportion of Participants With Chronic Allograft Nephropathy
Hide Description [Not Specified]
Time Frame Participants followed from transplantation until completion of study (up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Sample
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion with 95% exact binomial confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate
Estimated Value 0
Confidence Interval 95%
0 to 52.2
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Proportion of Participants With Delayed Graft Function
Hide Description [Not Specified]
Time Frame Participants followed from transplantation until completion of study (up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Sample
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion with 95% exact binomial confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate
Estimated Value 0
Confidence Interval 95%
0 to 52.2
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Proportion of Participants With Post-transplant Diabetes Mellitus
Hide Description [Not Specified]
Time Frame Participants followed from transplantation until completion of study (up to four years post-transplantation)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Sample
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description:
Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Participants
1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immunosuppression Withdrawal
Comments Proportion with 95% exact binomial confidence interval
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 95% exact binomial CI of proportion
Comments [Not Specified]
Method of Estimation Estimation Parameter Incidence Rate
Estimated Value 20
Confidence Interval 95%
0.5 to 71.6
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immunosuppression Withdrawal
Hide Arm/Group Description Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
All-Cause Mortality
Immunosuppression Withdrawal
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Immunosuppression Withdrawal
Affected / at Risk (%) # Events
Total   4/5 (80.00%)    
Blood and lymphatic system disorders   
Lymphocele  1  1/5 (20.00%)  1
Immune system disorders   
Kidney transplant rejection  1  4/5 (80.00%)  5
Respiratory, thoracic and mediastinal disorders   
Lung infiltration  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immunosuppression Withdrawal
Affected / at Risk (%) # Events
Total   5/5 (100.00%)    
Blood and lymphatic system disorders   
Anaemia  1  3/5 (60.00%)  3
Leukopenia  1  2/5 (40.00%)  3
Thrombocythaemia  1  1/5 (20.00%)  1
Cardiac disorders   
Palpitations  1  1/5 (20.00%)  1
Ear and labyrinth disorders   
Middle ear inflammation  1  1/5 (20.00%)  1
Endocrine disorders   
Hyperparathyroidism  1  1/5 (20.00%)  1
Eye disorders   
Vision blurred  1  1/5 (20.00%)  1
Gastrointestinal disorders   
Abdominal pain  1  1/5 (20.00%)  2
Abdominal pain upper  1  1/5 (20.00%)  1
Constipation  1  2/5 (40.00%)  2
Diarrhoea  1  4/5 (80.00%)  4
Mouth ulceration  1  2/5 (40.00%)  2
Nausea  1  4/5 (80.00%)  5
Vomiting  1  1/5 (20.00%)  1
General disorders   
Asthenia  1  1/5 (20.00%)  1
Fatigue  1  1/5 (20.00%)  4
Malaise  1  1/5 (20.00%)  1
Oedema  1  3/5 (60.00%)  4
Oedema peripheral  1  1/5 (20.00%)  1
Pyrexia  1  2/5 (40.00%)  2
Infections and infestations   
BK virus infection  1  2/5 (40.00%)  2
Cytomegalovirus viraemia  1  1/5 (20.00%)  3
Diverticulitis  1  1/5 (20.00%)  1
Epstein-Barr viraemia  1  1/5 (20.00%)  1
Folliculitis  1  1/5 (20.00%)  1
Herpes virus infection  1  1/5 (20.00%)  4
Oral infection  1  1/5 (20.00%)  1
Upper respiratory tract infection  1  1/5 (20.00%)  1
Urinary tract infection  1  2/5 (40.00%)  3
Vulvovaginal mycotic infection  1  1/5 (20.00%)  1
Injury, poisoning and procedural complications   
Graft dysfunction  1  1/5 (20.00%)  2
Incision site pain  1  2/5 (40.00%)  2
Medical device pain  1  1/5 (20.00%)  1
Procedural nausea  1  1/5 (20.00%)  2
Investigations   
Blood creatinine increased  1  1/5 (20.00%)  1
Weight increased  1  2/5 (40.00%)  3
Metabolism and nutrition disorders   
Acidosis  1  1/5 (20.00%)  1
Hypercholesterolaemia  1  1/5 (20.00%)  1
Hyperglycaemia  1  1/5 (20.00%)  1
Hyperphosphataemia  1  1/5 (20.00%)  1
Hypocalcaemia  1  2/5 (40.00%)  2
Hypokalaemia  1  1/5 (20.00%)  1
Hypomagnesaemia  1  3/5 (60.00%)  3
Hypophosphataemia  1  2/5 (40.00%)  2
Metabolic acidosis  1  1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/5 (20.00%)  2
Flank pain  1  1/5 (20.00%)  1
Pain in extremity  1  1/5 (20.00%)  2
Nervous system disorders   
Headache  1  1/5 (20.00%)  1
Tremor  1  1/5 (20.00%)  1
Psychiatric disorders   
Anxiety  1  1/5 (20.00%)  1
Insomnia  1  1/5 (20.00%)  2
Renal and urinary disorders   
Dysuria  1  1/5 (20.00%)  1
Haematuria  1  1/5 (20.00%)  1
Renal disorder  1  1/5 (20.00%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/5 (20.00%)  1
Scrotal oedema  1  1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/5 (20.00%)  1
Oropharyngeal pain  1  2/5 (40.00%)  3
Skin and subcutaneous tissue disorders   
Alopecia  1  1/5 (20.00%)  2
Dry skin  1  1/5 (20.00%)  1
Ecchymosis  1  2/5 (40.00%)  2
Rash  1  1/5 (20.00%)  1
Vascular disorders   
Hypertension  1  2/5 (40.00%)  2
Hypotension  1  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
The trial was stopped early due to meeting an acute rejection threshold of three acute rejections based on local pathology reads in the first five participants enrolled.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Director, Clinical Research Program
Organization: DAIT/NIAID
Phone: 301-594-7669
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00346151     History of Changes
Other Study ID Numbers: DAIT ITN023ST
First Submitted: June 27, 2006
First Posted: June 29, 2006
Results First Submitted: June 8, 2011
Results First Posted: November 7, 2011
Last Update Posted: April 21, 2017