mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal Transplantation

NCT ID: NCT01028092

Last Updated: 2014-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 327 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-07-31

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).

Conditions

Renal Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: ACTIVE_COMPARATOR

Anti R-IL2 + Cyclosporine

Intervention Type: DRUG

• 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

CNI-free

Thymoglobulin + Mycophenolate Mofetil + everolimus + corticosteroids

Group Type: EXPERIMENTAL

Thymoglobulin + Everolimus

Intervention Type: DRUG

• 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

Switch

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

Group Type: EXPERIMENTAL

Anti R-IL2 + Cyclosporine then Everolimus

Intervention Type: DRUG

• 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

Interventions

Anti R-IL2 + Cyclosporine

• 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

Intervention Type: DRUG

Thymoglobulin + Everolimus

• 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

Intervention Type: DRUG

Anti R-IL2 + Cyclosporine then Everolimus

• 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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%

Exclusion Criteria

• 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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yannick LE MEUR, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Brest

Locations

CHU Amiens

Amiens, , France

CHU Pellegrin - Bordeaux

Bordeaux, , France

CHRU de BREST

Brest, , France

CHU Cote de Nacre

Caen, , France

CHU Clermont Ferrand

Clermont-Ferrand, , France

CHU Dijon

Dijon, , France

CHU Lille

Lille, , France

CHU Limoges

Limoges, , France

CHU Montpellier

Montpellier, , France

CHU Nice

Nice, , France

AP-HP Hopital Necker

Paris, , France

CHU Poitiers

Poitiers, , France

CHU Reims

Reims, , France

CHU Rennes

Rennes, , France

CHU Rouen

Rouen, , France

Hopitaux Universitaires de Strasbourg

Strasbourg, , France

CHU Rangueil - Toulouse

Toulouse, , France

CHU Tours

Tours, , France

Countries

France

Other Identifiers

RB 09.074

Identifier Type: -

Identifier Source: secondary_id

EVEROLD

Identifier Type: -

Identifier Source: org_study_id