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An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens

NCT01183247 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2010-08-17

No results posted yet for this study

Summary

An open, single center, randomised study to investigate three different immunosuppressive regimens for de novo renal transplant recipients:

1. st sirolimus / EC-MPS / tacrolimus regimen

\- After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.
2. nd everolimus / EC-MPS / tacrolimus regimen

\- After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.
3. rd tacrolimus / EC-MPS / prednisone regimen - After 3 months a protocol biopsy is performed. If no rejection is detected prednisone is withdrawn.

Conditions

  • Comparative Study
  • Immunosuppressive Agents

Interventions

DRUG

Rapamycin

Add rapamycin de novo to tacrolimus and MMF

DRUG

Everolimus

Add everolimus de novo to tacrolimus and MMF

DRUG

Prednisone

Add prednisone de novo to tacrolimus and MMF

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Juerg U Steiger, Professor · University Hospital, Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
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 NCT01183247 on ClinicalTrials.gov