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

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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Failure
• Intervention / Treatment: Drug: cyclosporin + mycophenolate mofetil; Drug: everolimus + mycophenolate mofetil

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • Nephrology department, Hospital University of Amiens
  • Montpellier, France, 34285
    • Nephrology Department, University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cyclosporin + Mycophenolate mofetil	Drug: cyclosporin + mycophenolate mofetil; antirejection drug, renal transplantation
Experimental: Everolimus + mycophenolate mofetil	Drug: everolimus + mycophenolate mofetil; antirejection drug, renal transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evolution of glomerular filtration rate measured by clearance of iohexol	one year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Novartis

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2012
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 10, 2012

Study Record Updates

• Last Update Posted (Actual): August 21, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: transplantation; kidney; graft; creatinin
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Antitubercular Agents; Antibiotics, Antitubercular; Calcineurin Inhibitors; Mycophenolic Acid; Everolimus; Cyclosporine; Cyclosporins
• Other Study ID Numbers: PI10-PR-CHOUKROUN; 2011-001385-18 (EudraCT Number)