NCT02334488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2014

Longer than P75 for phase_3

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 11, 2014

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 8, 2015

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2020

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

4.5 years

First QC Date

November 3, 2014

Last Update Submit

January 28, 2021

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • Renal function as measured by estimated glomerular filtration rate GFR

    GFR unit : mL / min / 1.73 m2

    One year after inclusion

Study Arms (2)

Everolimus-Tacrolimus

ACTIVE COMPARATOR

* 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: EverolimusDrug: Tacrolimus

Everolimus-Mycophenolate sodium

EXPERIMENTAL

* 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: EverolimusDrug: Mycophenolate sodium

Interventions

EverolimusDRUG

Active Comparator

Also known as: Certican®
Everolimus-Mycophenolate sodiumEverolimus-Tacrolimus
TacrolimusDRUG

Active Comparator

Also known as: Prograg®
Everolimus-Tacrolimus
Mycophenolate sodiumDRUG

Experimental Arm

Also known as: Myfortic®
Everolimus-Mycophenolate sodium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Amiens University Hospital

Amiens, 80000, France

Location

Angers University Hospital

Angers, 49100, France

Location

Brest University Hospital

Brest, 29200, France

Location

Caen University Hospital

Caen, 14033, France

Location

Clermont Ferrand University Hospital

Clermont-Ferrand, 63000, France

Location

Limoges University Hospital

Limoges, 87000, France

Location

Georges Pompidou European Hospital

Paris, 75015, France

Location

Necker Hospital

Paris, 75015, France

Location

Poitiers University Hospital

Poitiers, 86000, France

Location

Reims University Hospital

Reims, 51000, France

Location

Rennes University Hospital

Rennes, 35000, France

Location

Rouen University Hospital

Rouen, 76000, France

Location

Strasbourg University Hospital

Strasbourg, 67000, France

Location

Tours University Hospital

Tours, 37000, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

EverolimusTacrolimusMycophenolic Acid

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Antoine THIERRY, MD

    Poitiers University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2014

First Posted

January 8, 2015

Study Start

December 11, 2014

Primary Completion

May 31, 2019

Study Completion

July 3, 2020

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

FR(14)