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Efficacy Study of Everolimus on Renal Function in Heart Transplant Recipients With Established Chronic Renal Failure

NCT00716573 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-06-20

No results posted yet for this study

Summary

After transplantation, renal impairment, incidence and progression of atherosclerosis lead to modification of immunosuppressive regimens, as switch, reduction or discontinuation of CNI and/or introduction of everolimus. The risk or benefits of these strategies were not clearly evaluated by specific clinical trials.

This study is specifically designed for evaluating the impact of everolimus introduction, with calcineurin dose reduction, at less one year after cardiac transplantation, on renal and clinical outcomes, specially on :

* Renal function improvement
* Vasculopathy and major cardiac event reduction
* Maintenance of immunosuppressive efficacy

Conditions

  • Cardiac Transplantation
  • Chronic Renal Insufficiency

Interventions

DRUG

everolimus

0,75 mg bid, 24 months

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Pascale BOISSONNAT, MD · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-16
Primary Completion
2014-04-17
Completion
2014-04-17

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT00716573 on ClinicalTrials.gov