Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Amiens University Hospital, Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Everolimus

Drug

Active Comparator

Other names: Certican®

Tacrolimus

Drug

Active Comparator

Other names: Prograg®

Mycophenolate sodium

Drug

Experimental Arm

Other names: Myfortic®

Primary outcomes

Renal function as measured by estimated glomerular filtration rate GFR

Time frame: One year after inclusion

GFR unit : mL / min / 1.73 m2

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2019
Study completion: 2020
First posted: Jan 8, 2015
Registry last updated: Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed