Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

Phase 3

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Everolimus; Drug: Tacrolimus; Drug: Mycophenolate sodium

• Registration Number: NCT02334488
• Lead Sponsor: Poitiers University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-03
• Study Start: 2014-12-11
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-08
• Primary Completion: 2019-05-31
• Study Completion: 2020-07-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus-Tacrolimus	Everolimus	* 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).
Everolimus-Tacrolimus	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).
Everolimus-Mycophenolate sodium	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.
Everolimus-Mycophenolate sodium	Everolimus	* 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.

Primary Outcome Measures

Name	Time	Method
Renal function as measured by estimated glomerular filtration rate GFR	One year after inclusion	GFR unit : mL / min / 1.73 m2

Trial Locations

Locations (14)

Angers University Hospital; 🇫🇷 Angers, France

Poitiers University Hospital; 🇫🇷 Poitiers, France

Reims University Hospital; 🇫🇷 Reims, France

Georges Pompidou European Hospital; 🇫🇷 Paris, France

Limoges University Hospital; 🇫🇷 Limoges, France

Amiens University Hospital; 🇫🇷 Amiens, France

Brest University Hospital; 🇫🇷 Brest, France

Tours University Hospital; 🇫🇷 Tours, France

Strasbourg University Hospital; 🇫🇷 Strasbourg, France

Necker Hospital; 🇫🇷 Paris, France

Caen University Hospital; 🇫🇷 Caen, France

Clermont Ferrand University Hospital; 🇫🇷 Clermont Ferrand, France

Rennes University Hospital; 🇫🇷 Rennes, France

Rouen University Hospital; 🇫🇷 Rouen, France