Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME)

NCT ID: NCT01595984

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-03
• Study Completion Date: 2018-08-31

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.

Conditions

Kidney Failure

Study Design

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

Study Groups

Cyclosporin + Mycophenolate mofetil

Group Type: ACTIVE_COMPARATOR

cyclosporin + mycophenolate mofetil

Intervention Type: DRUG

antirejection drug, renal transplantation

Everolimus + mycophenolate mofetil

Group Type: EXPERIMENTAL

everolimus + mycophenolate mofetil

Intervention Type: DRUG

antirejection drug, renal transplantation

Interventions

cyclosporin + mycophenolate mofetil

antirejection drug, renal transplantation

Intervention Type: DRUG

everolimus + mycophenolate mofetil

antirejection drug, renal transplantation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Males and Females aged between 18 and 70.
• 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.
• Patient with a malignant disease or a history of malignancy over the past 5 years except squamous-cell or basal cell carcinoma wich was excised.
• Medical condition or surgical procedure, except transplantation, which could exclude the patient in the opinion of the investigator.
• Patient with symptoms of mental or significant somatic illness. Disability to cooperate or communicate with the investigator.
• Pregnant, sucking or of childbearing age and refusing or being unable to use a recognized contraceptive method.
• Patient under guardianship, or any patient protected by law.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nephrology department, Hospital University of Amiens

Amiens, , France

Nephrology Department, University Hospital of Montpellier

Montpellier, , France

Countries

France

Other Identifiers

2011-001385-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PI10-PR-CHOUKROUN

Identifier Type: -

Identifier Source: org_study_id