Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

Phase 2

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Mycophenolate Mofetil; Drug: Rapamycin; Drug: Tacrolimus; Drug: Steroids

• Registration Number: NCT00533442
• Lead Sponsor: University of Miami

Brief Summary

This study was designed to determine which maintenance immunosuppressive agent, rapamycin or mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal failure, who presented for a kidney-pancreas transplant.

Detailed Description

This is a randomized, prospective single center study evaluating the two maintenance drugs above.

Study Timeline

• Study Start: 2000-09
• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-21
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2017-03-06
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-12
• Last Update Submitted: 2017-06-12
• Results First Posted: 2017-07-12
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

• Patient with Type 1 diabetes and end stage renal disease.
• Women of childbearing potential must have had a negative pregnancy test (serum or urine).
• Patient agrees to participate in the study and sign an informed consent.
• Patient has no known contraindication to the administration of rapamycin or mycophenolate mofetil.
• Patient has no history of hypersensitivity to rapamycin or mycophenolate mofetil.

Exclusion Criteria

• Patient has history of a malignancy within two years, with the exception of adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence.
• Patient is currently abusing drugs or alcohol.
• Patient is known or suspected to have an active infection or be seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) or human immunodeficiency virus (HIV).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus plus MMF plus Steroids	Mycophenolate Mofetil	Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Mycophenolate Mofetil (MMF), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
Tacrolimus plus MMF plus Steroids	Steroids	Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Mycophenolate Mofetil (MMF), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
Tacrolimus plus Rapamycin plus Steroids	Steroids	Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Rapamycin (Sirolimus), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
Tacrolimus plus MMF plus Steroids	Tacrolimus	Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Mycophenolate Mofetil (MMF), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
Tacrolimus plus Rapamycin plus Steroids	Rapamycin	Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Rapamycin (Sirolimus), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.
Tacrolimus plus Rapamycin plus Steroids	Tacrolimus	Patients randomized to this arm were scheduled to receive maintenance therapy consisting of Tacrolimus, Rapamycin (Sirolimus), and Steroids. Patients in both treatment arms received dual induction therapy consisting of Rabbit Anti-thymocyte Globulin (Thymoglobulin) plus Daclizumab.

Primary Outcome Measures

Name	Time	Method
Event-Specific Survival Comparisons	over 1-10 years post-transplant	Freedom from biopsy-proven acute rejection of the kidney allograft; Freedom from biopsy-proven acute rejection of the pancreas allograft; Death-censored kidney graft survival; Death-censored pancreas graft survival; Death-uncensored graft (kidney and pancreas) survival; and Patient survival.

Secondary Outcome Measures

Name	Time	Method
Overall Pancreas Transplant Function at 12, 36, and 60 Months Post-transplant.	at 1-5 years post-transplant	Comparisons of pancreas function (C-peptide in ng/mL) at 12, 36, and 60 months post-transplant.
Overall Kidney Transplant Function at 12, 36, and 60 Months Post-transplant.	at 1-5 years post-transplant	Comparisons of renal function (eGFR, measured in mL/min/1.73 m\^2) at 12, 36, and 60 months post-transplant.

Trial Locations

Locations (1)

University of Miami, Miller School of Medicine; 🇺🇸 Miami, Florida, United States