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COMPLETED
NCT01595984
PHASE3

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

Sponsor: Centre Hospitalier Universitaire, Amiens

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

88

Start Date

2012-05-03

Completion Date

2024-03-05

Last Updated

2026-06-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

cyclosporin + mycophenolate mofetil

antirejection drug, renal transplantation

DRUG

everolimus + mycophenolate mofetil

antirejection drug, renal transplantation

Locations (2)

Nephrology department, Hospital University of Amiens

Amiens, France

Nephrology Department, University Hospital of Montpellier

Montpellier, France