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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Centre Hospitalier Universitaire, Amiens
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01595984
First received: May 9, 2012
Last updated: May 11, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Kidney Failure
Drug: cyclosporin + mycophenolate mofetil
Drug: everolimus + mycophenolate mofetil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Evolution of glomerular filtration rate measured by clearance of iohexol [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 134
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595984

Locations
France
Nephrology department, Hospital University of Amiens Recruiting
Amiens, France, 80000
Contact: Gabriel CHOUKROUN, Ph D    00 333 22 45 58 62    choukroun.gabriel@chu-amiens.fr   
Nephrology Department, University Hospital of Montpellier Active, not recruiting
Montpellier, France, 34285
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Novartis
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01595984     History of Changes
Other Study ID Numbers: PI10 - Pr. CHOUKROUN, 2011-001385-18
Study First Received: May 9, 2012
Last Updated: May 11, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
kidney
transplantation
graft
creatinin

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Cyclosporins
Cyclosporine
Mycophenolate mofetil
Mycophenolic Acid
Everolimus
Sirolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on August 26, 2014