Simultaneous Pancreas-kidney Transplantation With Campath Protocol
Austria30 participantsStarted 2006-04
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…