Conditions: Type 1 Diabetes
Keywords: Rapamycin Mycophenolate Mofetil (MMF) Kidney-Pancreas Transplant
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 170
Healthy volunteers: no

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.

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Rapamycin intervention 2: Mycophenolate Mofetil intervention 3: Tacrolimus intervention 4: Steroids
Intervention descriptions: intervention 1: 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. intervention 2: MMF 1 gm BID beginning 1st day postoperative day intervention 3: Part of standard maintenance. intervention 4: Part of standard maintenance

Protocol document: