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A Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus

Kidney Transplant Recipients Clinical Trial

Official title:
An Open-label Randomized Controlled Clinical Trial to Assess the Efficacy and Safety of the Conversion to Everolimus 3 Months After Kidney Transplantation.

Clinical Trial Summary

The study hypotheses to be tested in this study are:

- Conversion to everolimus at 3 months post-transplantation is safe and effective;

- Accurate noninvasive molecular diagnostic tests can replace biopsy at 3 months pre-conversion (for the diagnosis of subclinical cellular and/or humoral rejection, tissue fibrosis and calcineurin inhibitor-induced nephrotoxicity) in kidney transplant recipients;

- Follow-up biopsy at 12 months post-conversion (for the diagnosis of tissue fibrosis) can be replaced with accurate noninvasive molecular diagnostic tests in kidney transplant recipients.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01608412
Study type Interventional
Source Hospital de Clinicas de Porto Alegre
Contact Luiz Felipe S. Gonçalves, MD
Email lfgoncalves@hcpa.ufrgs.br
Status Recruiting
Phase Phase 4
Start date February 2012
Completion date July 2014
View Details
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