Shift to Everolimus (RAD) Kidney Sparing Study

NCT00420537 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2010-01-12

No results posted yet for this study

Summary

The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.

Conditions

  • Kidney Dysfunction
  • Heart Transplantation

Interventions

DRUG

cyclosporine

cyclosporine trough levels between 100 and 150

DRUG

cyclosporine

cyclosporine trough levels between 40 and 90 ng/ml

DRUG

Mycophenolate mofetil

mycophenolate with low doses

DRUG

Everolimus

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Principal Investigators

  • Angelo Branzi, MD · Alma Mater Studiorum University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-01-31
Completion
2009-03-31

Countries

  • Italy

Study Locations

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Entities

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 NCT00420537 on ClinicalTrials.gov