Simultaneous Pancreas-kidney Transplantation With Campath Protocol

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr. Claudia Bösmüller
• Collaborator: Astellas Pharma GmbH
• Treatments: Alemtuzumab; Methylprednisolone; Tacrolimus; Thymoglobulin

Criteria

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.