NCT00140543

European Trial of Immunosuppression in SPK Tx

A European Multicenter Open-Label Randomised Trial to Evaluate the Efficacy and Safety of Sirolimus and Tacrolimus Compared to MMF and Tacrolimus With Short-Course Induction Therapy, Short-Term Steroids Application in de Novo SPK Transplanted Diabetic Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (planned)
• Sponsor: EUROSPK Study Group · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	sirolimus versus mycophenolate mofetil

Timeline

• Start date: 2002-02-01
• Completion: 2005-09-30
• First posted: 2005-09-01
• Last updated: 2021-08-23

Locations

14 sites across 7 countries: Austria, Belgium, Czechia, Germany, Israel, Spain, Switzerland