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

NCT01595984 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-08-21

No results posted yet for this study

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

Interventions

DRUG

cyclosporin + mycophenolate mofetil

antirejection drug, renal transplantation

DRUG

everolimus + mycophenolate mofetil

antirejection drug, renal transplantation

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-03
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • France

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01595984 on ClinicalTrials.gov