Status:
COMPLETED
European Trial of Immunosuppression in SPK Tx
Lead Sponsor:
EUROSPK Study Group
Collaborating Sponsors:
Fujisawa GmbH
Hoffmann-La Roche
Conditions:
Diabetes Mellitus, Type 1
Diabetic Nephropathy
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
1. To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based immunosuppression (in conjunction with initial short-term steroids and polyclonal antibody administration) in Ty...
Detailed Description
This will be a controlled, randomised study, to be performed in 15-20 pancreas transplantation centers throughout Europe. Patients will be randomised into one of two treatment groups. Group 1 will rec...
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, Sirolimus, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.
- Patient has a positive T-cell crossmatch on the most recent serum specimen.
- 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 :
February 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 30 2005
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00140543
Start Date
February 1 2002
End Date
September 30 2005
Last Update
August 23 2021
Active Locations (14)
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1
Universitätsklinik
Innsbruck, Austria, 6020
2
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
3
UZ Gent
Ghent, Belgium, 9000
4
UZ Gasthuisberg
Leuven, Belgium, 3000