Randomized, Multicenter, Open-label, Comparative Study of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI), Associating Myfortic ® and Neoral ® Compared to a CNI-free Treatment, Combining Myfortic ® and Certican ® , in Adult Patients With de Novo Renal Transplant

Centre Hospitalier Universitaire, Amiens2 sites in 1 country90 target enrollmentMay 3, 2012

ConditionsKidney Failure

Interventionseverolimus + mycophenolate mofetil cyclosporin + mycophenolate mofetil

Overview

Phase: Phase 3
Intervention: everolimus + mycophenolate mofetil
Conditions: Kidney Failure
Sponsor: Centre Hospitalier Universitaire, Amiens
Enrollment: 90
Locations: 2
Primary Endpoint: Evolution of glomerular filtration rate measured by clearance of iohexol
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant.

Renal function will be accurately evaluated by measuring the clearance of iohexol.

The protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.

Registry

clinicaltrials.gov

Start Date

May 3, 2012

End Date

August 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire, Amiens

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males and Females aged between 18 and
•Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated.
•Patient with a maximum PRA \<20%.
•Patient wishing and being able to participate fully to the study, and having given a written consent.
•Patient covered by a social insurance or beneficiary of such a regime.
•Women of childbearing age must use a recognized method of contraception throughout the study period and continue for 8 weeks after discontinuation of study treatment.

Exclusion Criteria

•Patient receiving a kidney from a heart attack donor , or an ABO incompatible donor or a donor with a positive T-cross match.
•Patient with a maximum PRA\> 20% twice.
•Cold ischemic time \> 36 hours.
•Patients with thrombocytopenia (\<75000/mm3), neutropenia (\<1 500 / mm3), leukopenia (\<2 500 / mm3) or a hemoglobin concentration \<8 g / dl, at inclusion visit.
•Patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol / l (≥ 3.50 g / l) and / or triglycerides ≥ 8.5 mmol/l (≥ 7.5 g / l) despite appropriate lipid-lowering therapy.
•Patient with known HIV positive status, know active hepatitis B or C. Recipients of an organ from a donor with positive HIV status, hepatitis B or hepatitis C are excluded.
•Patient with severe systemic infections requiring continued therapy.
•Treatment with an experimental drug within 4 weeks before the first dose of study treatment.
•Patient for whom the initial disease or other pathology requires a long-term corticosteroid treatment.
•Patient with a history of hypersensitivity or known contra-indications for macrolide or inhibitors of mTORs drugs; drugs similar to Myfortic ® (ERL080) or other components of the formulation such as lactose, or cyclosporine, or prednisone (Cortancyl ®), or Thymoglobuline ® or Iohexol.