Simultaneous Pancreas-kidney Transplantation With Campath Protocol
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pancreas-Kidney Transplantation |
Drug: Alemtuzumab Drug: Rabbit Anti-Human Thymocyte Globulin |
Phase 3 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 30 |
| Study Start Date: | April 2006 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Campath
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. |
Drug: Alemtuzumab
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female patients of 18 to 55 years of age with end-stage, C-peptide-negative, Type 1-diabetic nephropathy.
- Female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (3 years).
- Patient must have signed the Patient Informed Consent Form.
- Patient must receive a primary simultaneous pancreas-kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.
Exclusion Criteria:
- Patient is pregnant or breastfeeding.
- Patient is allergic or intolerant to Mycophenolate Mofetil, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.
- Past history of anaphylaxis following exposure to humanized monoclonal antibodies.
- Patient has a positive T-cell crossmatch on the most recent serum specimen.
- CMV-match: D+ / R-.
- Patient is known for active liver disease or has significant liver disease; defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
- Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
- Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
- Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
- Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
- Pancreatic duct occlusion technique.
- Donor is older than 55 years of age.
Contacts and Locations| Austria | |
| 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 |
More Information
Publications:
| Responsible Party: | Dr. Claudia Bösmüller, Dr. med., Medical University Innsbruck |
| ClinicalTrials.gov Identifier: | NCT00316810 History of Changes |
| Other Study ID Numbers: | SIMPATICO, EudraCT Number: 2006-000845-21 |
| Study First Received: | April 19, 2006 |
| Last Updated: | June 18, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care |
Keywords provided by Medical University Innsbruck:
|
Campath 1H Alemtuzumab Tacrolimus |
Pancreas-kidney transplantation immunosuppression prevention of acute rejection |
Additional relevant MeSH terms:
|
Tacrolimus Campath 1G Alemtuzumab Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013