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

Renal Transplant Clinical Trial

— EVEROLD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028092
• Other study ID #: EVEROLD
• Secondary ID: RB 09.074
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2009
• Last updated: July 7, 2014
• Start date: March 2009
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. completion date: July 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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%

Other protocol-defined inclusion/exclusion criteria may apply.

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplant

Intervention

Drug:
• 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
• 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
• 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

Locations

Country	Name	City	State
France	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

Sponsors (5)

Lead Sponsor	Collaborator
University Hospital, Brest	Genzyme, a Sanofi Company, Ministry of Health, France, Novartis, Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	calculated renal function with MDRD equation		12 months	No
Secondary	Acute rejection rate		12 months	Yes
Secondary	Patient and graft survival rate		12 months	Yes
Secondary	Adverse events		12 months	Yes
Secondary	GFR calculated with Cockcroft Gault formula		12 months	No