Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

January 28, 2021 updated by: Poitiers University Hospital

Prospective Multicenter Randomized Openlabel Study to Evaluate the Benefit on Renal Function at 12months Post-transplantation of Immunosuppressive Treatment With Withdrawal of Calcineurin Inhibitor at 3months and Combining Mycophenolate Sodium-Everolimus Versus Tacrolimus-Everolimus, in Patients With de Novo Kidney Transplant

Prospective, multicenter, randomized and open label study evaluating the benefit on renal function at 12 months post-transplantation, with an immunosuppression without calcineurin inhibitor at 3 months and combining mycophenolate sodium-Everolimus versus an immunosuppression combining Everolimus-Tacrolimus, in de novo renal transplant patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

329

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80000
        • Amiens University Hospital
      • Angers, France, 49100
        • Angers University Hospital
      • Brest, France, 29200
        • Brest University Hospital
      • Caen, France, 14033
        • Caen University Hospital
      • Clermont Ferrand, France, 63000
        • Clermont Ferrand University Hospital
      • Limoges, France, 87000
        • Limoges University Hospital
      • Paris, France, 75015
        • Necker hospital
      • Paris, France, 75015
        • Georges Pompidou European hospital
      • Poitiers, France, 86000
        • Poitiers University Hospital
      • Reims, France, 51000
        • Reims University Hospital
      • Rennes, France, 35000
        • Rennes University Hospital
      • Rouen, France, 76000
        • Rouen University Hospital
      • Strasbourg, France, 67000
        • Strasbourg University Hospital
      • Tours, France, 37000
        • Tours University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients receiving a first kidney transplant from a cadaveric or living donor

Exclusion Criteria:

  • Double transplant
  • Patient who has been treated with an immunosuppressive drug or study drug during the four weeks before administration of the first dose of Everolimus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Everolimus-Tacrolimus
  • Tacrolimus (Prograf®) started at 0,1 mg/kg/day since Day0, then adapted to C0 concentration (4-7 ng/ml),
  • Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml).
Drug: Everolimus
Active Comparator
Other Names:
  • Certican®
Drug: Tacrolimus
Active Comparator
Other Names:
  • Prograg®
Experimental: Everolimus-Mycophenolate sodium
  • Everolimus (Certican®) started within 24h after reperfusion, to be adapted to C0 concentration (3-8 ng/ml),
  • Tacrolimus (Prograg®) started at 0,1 mg/kg/day from J0 then to be adapted to C0 concentration (4-7 ng/ml), then replacement by mycophenolate sodium (Myfortic®) at M3 (3 months visit) started at 1440 mg/day.
Drug: Everolimus
Active Comparator
Other Names:
  • Certican®
Drug: Mycophenolate sodium
Experimental Arm
Other Names:
  • Myfortic®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal function as measured by estimated glomerular filtration rate GFR
Time Frame: One year after inclusion
GFR unit : mL / min / 1.73 m2
One year after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Antoine THIERRY, MD, Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2014

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

July 3, 2020

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimate)

January 8, 2015

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROMéTé

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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