Status:
COMPLETED
Simultaneous Pancreas-kidney Transplantation With Campath Protocol
Lead Sponsor:
Dr. Claudia Bösmüller
Collaborating Sponsors:
Astellas Pharma GmbH
Conditions:
Pancreas-Kidney Transplantation
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief 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 patient...
Detailed Description
Simultaneous pancreas-kidney (SPK) transplantation is a recommended treatment option for type 1-diabetic patients suffering from end-stage kidney disease.1 Major factors contributing to the success of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00316810
Start Date
April 1 2006
End Date
June 1 2011
Last Update
June 19 2012
Active Locations (1)
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1
University Hospital Innsbruck
Innsbruck, Tyrol, Austria, 6020