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Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Everolimus
Tacrolimus
Mycophenolate sodium
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amiens University Hospital
  • Angers University Hospital
  • Brest University Hospital
  • Caen University Hospital
  • Clermont Ferrand University Hospital
  • Limoges University Hospital
  • Georges Pompidou European Hospital
  • Necker Hospital
  • Poitiers University Hospital
  • Reims University Hospital
  • Rennes University Hospital
  • Rouen University Hospital
  • Strasbourg University Hospital
  • Tours University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Everolimus-Tacrolimus

Everolimus-Mycophenolate sodium

Arm Description

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 (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.

Outcomes

Primary Outcome Measures

Renal function as measured by estimated glomerular filtration rate GFR
GFR unit : mL / min / 1.73 m2

Secondary Outcome Measures

Full Information

First Posted
November 3, 2014
Last Updated
January 28, 2021
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02334488
Brief Title
Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 11, 2014 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
July 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
329 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Everolimus-Tacrolimus
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Everolimus-Mycophenolate sodium
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
Certican®
Intervention Description
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Prograg®
Intervention Description
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Mycophenolate sodium
Other Intervention Name(s)
Myfortic®
Intervention Description
Experimental Arm
Primary Outcome Measure Information:
Title
Renal function as measured by estimated glomerular filtration rate GFR
Description
GFR unit : mL / min / 1.73 m2
Time Frame
One year after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine THIERRY, MD
Organizational Affiliation
Poitiers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
ZIP/Postal Code
80000
Country
France
Facility Name
Angers University Hospital
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Brest University Hospital
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Clermont Ferrand University Hospital
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Limoges University Hospital
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Georges Pompidou European Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Necker Hospital
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Poitiers University Hospital
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Reims University Hospital
City
Reims
ZIP/Postal Code
51000
Country
France
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Strasbourg University Hospital
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Tours University Hospital
City
Tours
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

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Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

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