Simultaneous Pancreas-kidney Transplantation With Campath Protocol
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|ClinicalTrials.gov Identifier: NCT00316810|
Recruitment Status : Completed
First Posted : April 21, 2006
Last Update Posted : June 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pancreas-Kidney Transplantation||Drug: Alemtuzumab Drug: Rabbit Anti-Human Thymocyte Globulin||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||June 2011|
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
- Biopsy-proven (Kidney) rejection episodes [ Time Frame: Year 1 ]
- Kidney/Pancreas function [ Time Frame: Month 6 and Year 1 ]
- Patient and graft survival [ Time Frame: Month 6 and Year 1 ]
- Lipid profile ( Total Cholesterol, HDL, LDL, Triglycerides, Treatment with statins) [ Time Frame: Month 6 and Year 1 ]
- Infections [ Time Frame: Month 6 and Year 1 ]
- Side effects [ Time Frame: Month 6 and Year 1 ]
- Blood Pressure [ Time Frame: Month 6 and Year 1 ]
- 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 ]
- Percentage of steroid free patients [ Time Frame: Month 6 and Year 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|