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Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533442
First Posted: September 21, 2007
Last Update Posted: July 12, 2017
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.
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
George W. Burke, University of Miami
Results First Submitted: March 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Type 1 Diabetes
Interventions: Drug: Rapamycin
Drug: Mycophenolate Mofetil
Drug: Tacrolimus
Drug: Steroids

  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
From September 1, 2000 through December 15, 2009, 170 consecutive patients with type 1 diabetes and ESRD were randomized to receive either Rapamycin (N=84) or MMF (N=86) immediately prior to transplant. Post-transplant clinical follow-up of patients continued through January 15, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A randomized block design was implemented for the randomization scheme using Proc Plan in SAS. Patients were randomly assigned (allocation ratio of 1:1) to the two treatment arms in blocks of 4 and 6 patients (block sizes were also chosen randomly), ensuring a balance of patients across treatment arms after each block of patients was randomized.

Reporting Groups
  Description
Tacrolimus Plus MMF Plus Steroids

This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.

Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day

Tacrolimus Plus Rapamycin Plus Steroids

Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.

Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.

Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:

10-15ng/ml)

Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.


Participant Flow for 2 periods

Period 1:   Allocation and Intent to Treat Analysis
    Tacrolimus Plus MMF Plus Steroids   Tacrolimus Plus Rapamycin Plus Steroids
STARTED   86   84 
COMPLETED   86   84 
NOT COMPLETED   0   0 

Period 2:   Follow-up
    Tacrolimus Plus MMF Plus Steroids   Tacrolimus Plus Rapamycin Plus Steroids
STARTED   86 [1]   84 [2] 
COMPLETED   77   74 
NOT COMPLETED   9   10 
[1] Ongoing Follow-up at 13-123 months (N=77); Lost to Follow-up (N=9, at 5-100 months).
[2] Ongoing Follow-up at 17-124 months (N=74); Lost to Follow-up (N=10, at 5-67 months).



  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.
No text entered.

Reporting Groups
  Description
Tacrolimus Plus MMF Plus Steroids

This group of kidney-pancreas recipients was randomized to receive mycophenolate mofetil and tacrolimus after transplantation.

Tacrolimus and mycophenolate mofetil: MMF 1 gm BID beginning 1st day postoperative day

Tacrolimus Plus Rapamycin Plus Steroids

Patients randomized to this arm received Sirolimus, after kidney-pancreas transplantation.

Rapamycin: Rapamycin was initiated on day 1 postoperatively, 4mg/day;levels were maintained 5-8ng/ml. Those patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.

Rapamune and Tacrolimus: Sirolimus 2 mg/day beginning 1st postoperative day (trough target levels:

10-15ng/ml)

Mycophenolate Mofetil: Patients randomized to receive mycophenolate mofetil were given 1gm twice/day starting on the first post-operative day.

Total Total of all reporting groups

Baseline Measures
   Tacrolimus Plus MMF Plus Steroids   Tacrolimus Plus Rapamycin Plus Steroids   Total 
Overall Participants Analyzed 
[Units: Participants]
 86   84   170 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.4  (9.3)   41.5  (8.2)   42.5  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      31  36.0%      34  40.5%      65  38.2% 
Male      55  64.0%      50  59.5%      105  61.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Caucasian   55   47   102 
Hispanic   19   31   50 
African-American   11   6   17 
Other   1   0   1 


  Outcome Measures
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1.  Primary:   Event-Specific Survival Comparisons   [ Time Frame: over 1-10 years post-transplant ]

2.  Secondary:   Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant.   [ Time Frame: at 1-5 years post-transplant ]

3.  Secondary:   Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant.   [ Time Frame: at 1-5 years post-transplant ]


  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 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: Dr. George W. Burke, III
Organization: University of Miami
phone: 305-355-5111
e-mail: gburke@med.miami.edu


Publications of Results:

Responsible Party: George W. Burke, University of Miami
ClinicalTrials.gov Identifier: NCT00533442     History of Changes
Other Study ID Numbers: 20000176
First Submitted: September 19, 2007
First Posted: September 21, 2007
Results First Submitted: March 6, 2017
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017