Simultaneous Pancreas-kidney Transplantation With Campath Protocol
The purpose of this study is to determine and compare the efficacy of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF therapy in conjunction with initial short-term steroids in Type 1-diabetic patients undergoing simultaneous pancreas-kidney allograft transplantation as well as to evaluate the safety of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF in terms of drug-related complications and immunosuppression-associated complications.
Drug: Rabbit Anti-Human Thymocyte Globulin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Randomized, Prospective Study to Investigate the Safety and Efficacy of Campath-1H as an Induction Agent in Combination With Tacrolimus Monotherapy Compared to Short-course ATG-induction in Combination With Tacrolimus, Mycophenolate Mofetil and Short-term Steroids Application in de Novo SPK Transplanted Diabetic Patients|
- Biopsy-proven (Kidney) rejection episodes [ Time Frame: Year 1 ] [ Designated as safety issue: Yes ]
- Kidney/Pancreas function [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
- Patient and graft survival [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
- Lipid profile ( Total Cholesterol, HDL, LDL, Triglycerides, Treatment with statins) [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
- Infections [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
- Side effects [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
- Blood Pressure [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
- Treatment failure for any reason, such as permanent discontinuation of a drug, change from immunosuppressive protocol, graft loss or death [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
- Percentage of steroid free patients [ Time Frame: Month 6 and Year 1 ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||June 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Day 0: Before revascularisation patients are given 500 mg of Methylprednisolone i.v. followed by Campath 30 mg i.v. infusion over 3-6 hours.
Day 1: No treatment
Day 2: Initial dose of Tacrolimus 0.05 - 0.1 mg/kg/d orally.
till Month 6: Aim at blood level of 12-15 ng/ml (try to prevent the Tacrolimus trough level falling below 12 ng/ml in the first 6 months).
Month 7-12: Maintain the Tacrolimus blood level at 6-12 ng/ml after 6 months.
Day 0: Campath 30 mg i.v. infusion over 3-6 hours
Other Name: MABCAMPATH
Active Comparator: ATG
Day 0: Prior to revascularisation patients are given 500 mg of Methylprednisolone i.v. followed by a single shot of a polyclonal antilymphocyte preparation. Tacrolimus will be given immediately after transplantation(0.05-0.1 mg/kg/d) orally. Preoperative loading dose MMF: 2 g orally.
From Day 1: Total initial daily dose of 0.05-0.1 mg/kg administered orally in 2 doses. Blood trough levels 12-15 ng/ml during the first 6 months and maintain blood levels 6-12 ng/ml after 6 months. Total daily dose of MMF is 2 g administered orally in 2 doses. Patients will receive Methylprednisolone 250 mg IV 12h post surgery and 125 mg of Methylprednisolone 24 h post transplantation.
Steroid taper (orally):
Day 2: 100 mg of Prednisolon Day 3: 80 mg of Prednisolon Day 4: 60 mg of Prednisolon Day 5: 40 mg of Prednisolon Day 6: 25 mg of Prednisolon Day 21: 20 mg of Prednisolon
Reduction by 5 mg in two week intervals/complete withdrawal by 3 months post-tx.
Drug: Rabbit Anti-Human Thymocyte Globulin
Day O: Single shot of a polyclonal antilymphocyte preparation (ATG-Fresenius - 8 mg/kg, or IMTIX-Sangstat ATG 4 mg/kg/day).
Other Name: ATG-S FRESENIUS
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00316810
|University Hospital Innsbruck|
|Innsbruck, Tyrol, Austria, 6020|
|Principal Investigator:||Johann Pratschke, Prof. Dr.||University Hospital Innsbruck, Dept. of General- and Transplant Surgery, Anichstrasse 35, A-6020 Innsbruck|