NCT01028092

Brief Summary

This study is designed to evaluate efficacity and safety of everolimus or (cyclosporine then everolimus) vs. cyclosporine as immunosuppressive treatment in renal transplantation for elderly (\>60 years old) recipients receiving graft from elderly donor(\>60 years old).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
327

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_3

Geographic Reach
1 country

18 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

Study Start

First participant enrolled

March 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

5 years

First QC Date

December 8, 2009

Last Update Submit

July 7, 2014

Conditions

Renal Transplant

Outcome Measures

Primary Outcomes (1)

  • calculated renal function with MDRD equation

    12 months

Secondary Outcomes (4)

  • Acute rejection rate

    12 months

  • Patient and graft survival rate

    12 months

  • Adverse events

    12 months

  • GFR calculated with Cockcroft Gault formula

    12 months

Study Arms (3)

Control

ACTIVE COMPARATOR

anti R-IL2 induction + Mycophenolate Mofetil + cyclosporine A + corticosteroids

Drug: Anti R-IL2 + Cyclosporine

CNI-free

EXPERIMENTAL

Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids

Drug: Thymoglobulin + Everolimus

Switch

EXPERIMENTAL

anti R-IL2 + Mycophenolate Mofetil + (Cyclosporine then Everolimus) + corticosteroids

Drug: Anti R-IL2 + Cyclosporine then Everolimus

Interventions

Anti R-IL2 + CyclosporineDRUG

* anti R-IL2 induction (Simulect ®, 20 mg D0 and D4) * Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0 * cyclosporine A (Neoral ®) started from 6 to 8 mg/kg adjusted to C2 * corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6

Control
Thymoglobulin + EverolimusDRUG

* Thymoglobulin ® induction started at 1.5mg/kg/j then adjusted to CD2 or total lymphocytes count, for 5 days * Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0 * everolimus (Certican ®): 4 to 6 mg/day started at D5, adjusted to achieve a residual level between 6 et 10 ng/ml * corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6

CNI-free
Anti R-IL2 + Cyclosporine then EverolimusDRUG

* anti R-IL2 induction (Simulect ®, 20 mg D0 and D4) * Mycophenolate Mofetil (Cellcept ®) 3 g/d beginning at D0 * cyclosporine A (Neoral ®) beginning at 6 to 8 mg/kg adjusted to C2, then switch to everolimus (Certican ®) between at W6, started at 3 mg/d, then adjusted to achieve a residual level between 6 et 10 ng/ml * corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6

Switch

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who has given written informed consent to participate in the study
  • First or second single transplantation of a recipient (male or female) older than 60 years old
  • Donor older than 60 years old
  • PRA \< 30%

You may not qualify if:

  • Living donor
  • Third transplantation
  • PRA \> 30%
  • Recipient of multi-organ transplant
  • Active major infections (HBV, HCV, HIV)
  • Loss of a first graft for immunologic issues
  • Anemia (\<9g/l) or leucopenia (\<2500/mm3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

CHU Amiens

Amiens, France

Location

CHU Pellegrin - Bordeaux

Bordeaux, France

Location

CHRU de BREST

Brest, 29609, France

Location

CHU Cote de Nacre

Caen, France

Location

CHU Clermont Ferrand

Clermont-Ferrand, France

Location

CHU Dijon

Dijon, France

Location

CHU Lille

Lille, France

Location

CHU Limoges

Limoges, France

Location

CHU Montpellier

Montpellier, France

Location

CHU Nice

Nice, France

Location

AP-HP Hopital Necker

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Reims

Reims, France

Location

CHU Rennes

Rennes, France

Location

CHU Rouen

Rouen, France

Location

Hopitaux Universitaires de Strasbourg

Strasbourg, France

Location

CHU Rangueil - Toulouse

Toulouse, France

Location

CHU Tours

Tours, France

Location

MeSH Terms

Interventions

CyclosporinethymoglobulinEverolimus

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsSirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Yannick LE MEUR, MD/PhD

    CHU de Brest

    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

December 8, 2009

First Posted

December 9, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2014

Study Completion

July 1, 2014

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

FR(18)