European Trial of Immunosuppression in SPK Tx

NCT ID: NCT00140543

Last Updated: 2021-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2005-09-30

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 Type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation.

2. To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related complications and overimmunosuppression-associated complications, particularly under monitoring of the pharmacokinetic profile of all drugs administered.

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 receive Tacrolimus and Mycophenolate Mofetil (= best group in EuroSPK001 trial). Group 2 will receive Tacrolimus and Sirolimus. Both groups will receive in association short-term corticosteroids and polyclonal antibody preparation. Patients will be randomly assigned to one of the 2 treatment groups in a 1:1 ratio before transplantation. The study will last 3 years, with a first interim analysis of the data at 6 months and a complete analysis at 1 year.

Conditions

Diabetes Mellitus, Type 1; Diabetic Nephropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

sirolimus versus mycophenolate mofetil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female patients, of 18 to 55 years of age, with end-stage, C-peptide-negative, Type 1-diabetic nephropathy.

2. 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).

3. Patient must have signed the Patient Informed Consent Form.

4. 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

1. Patient is pregnant or breastfeeding.

2. Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.

3. Patient has a positive T-cell crossmatch on the most recent serum specimen.

4. 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.

5. Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.

6. Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.

7. Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.

8. Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.

9. Pancreatic duct occlusion technique .

10. Donor is older than 55 years of age.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujisawa GmbH

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

Neovii Biotech

INDUSTRY

Sponsor Role: collaborator

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

EUROSPK Study Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Paul Squifflet, MD,PhD

Role: STUDY_CHAIR

SPEAKER FOR THE EUROSPK STUDY GROUP

Locations

Universitätsklinik

Innsbruck, , Austria

Cliniques Universitaires Saint Luc

Brussels, , Belgium

UZ Gent

Ghent, , Belgium

UZ Gasthuisberg

Leuven, , Belgium

Institute for clinical and experimental medicine-IKEM

Prague, , Czechia

Charite Campus Virchow Klinikum

Berlin, , Germany

Goethe University

Frankfurt am Main, , Germany

Chirurgische Universitätsklinik

Freiburg im Breisgau, , Germany

Knappschaftskrankenhaus

Langendreer, , Germany

Klinikum Grosshadern-University of Munich

Munich, , Germany

Klinikum Innenstadt der Universität München

Munich, , Germany

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Hospital Clinico

Barcelona, , Spain

Hôpital Cantonal de Geneve

Geneva, , Switzerland

Countries

Austria; Belgium; Czechia; Germany; Israel; Spain; Switzerland

Other Identifiers

EUROSPK002

Identifier Type: -

Identifier Source: org_study_id