MedTrace Logo

Phase IV Study to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation

NCT00724022 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2014-10-01

No results posted yet for this study

Summary

Current practice of immune suppressive standard therapy after renal transplantation in non-risk patients is a triple therapy consisting of steroids, a calcineurin inhibitor and MMF. The aim of this clinical trial is to combine a reduction of CNI using tacrolimus and a concept of not using steroids in order to establish an immunosuppressive regimen in immunologically non-risk patients that is efficient and causes as few side effects as possible.

Conditions

  • Disorder Related to Renal Transplantation

Interventions

DRUG

Basiliximab, Tacrolimus, MMF, Prednisolon

Control group. Therapy with Prednisolon.

DRUG

Basiliximab, Tacrolimus, MMF

No Prednisolon after 7 days

DRUG

Tacrolimus, MMF, rATG

Induction therapy: rATG instead of Basiliximab. No Prednisolon.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Astellas Pharma GmbH

    collaborator INDUSTRY

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Ulrich Hopt, Prof.Dr.Dr. · University Hospital Freiburg

  • Oliver Thomusch, Prof. Dr. · University Hospital Freiburg

  • Christian Hugo, Prof. Dr. · Universitaetsklinikum Erlangen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT00724022 on ClinicalTrials.gov