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European Trial of Immunosuppression in SPK Tx

NCT00140543 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2021-08-23

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1
  • Diabetic Nephropathy

Interventions

DRUG

sirolimus versus mycophenolate mofetil

Sponsors & Collaborators

  • Fujisawa GmbH

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Wyeth is now a wholly owned subsidiary of Pfizer

    collaborator INDUSTRY

  • Neovii Biotech

    collaborator INDUSTRY

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • EUROSPK Study Group

    lead OTHER

Principal Investigators

  • Jean-Paul Squifflet, MD,PhD · SPEAKER FOR THE EUROSPK STUDY GROUP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-02-28
Completion
2005-09-30

Countries

  • Austria
  • Belgium
  • Czechia
  • Germany
  • Israel
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00140543 on ClinicalTrials.gov