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

NCT01595984 | Completed Phase 3 DMC

• 2 other identifiers: PI10-PR-CHOUKROUN2011-001385-18
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

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

Keywords

kidney; transplantation; graft; creatinin

Outcome Measures

Primary Outcomes (1)

• Evolution of glomerular filtration rate measured by clearance of iohexol

  one year

Study Arms (2)

Cyclosporin + Mycophenolate mofetil

ACTIVE COMPARATOR

Drug: cyclosporin + mycophenolate mofetil

Everolimus + mycophenolate mofetil

EXPERIMENTAL

Drug: everolimus + mycophenolate mofetil

Interventions

cyclosporin + mycophenolate mofetil DRUG

antirejection drug, renal transplantation

Cyclosporin + Mycophenolate mofetil

everolimus + mycophenolate mofetil DRUG

antirejection drug, renal transplantation

Everolimus + mycophenolate mofetil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Novartis: collaborator
• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (2)

Nephrology department, Hospital University of Amiens

Amiens, 80000, France

Location

Nephrology Department, University Hospital of Montpellier

Montpellier, 34285, France

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Cyclosporine; Mycophenolic Acid; Everolimus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Sirolimus; Macrolides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 10, 2012
• Study Start: May 3, 2012
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

FR (2)