drugset / Trial / NCT01608412

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

NCT01608412

Phase 4 Unknown 120 enrolled Hospital de Clinicas de Porto Alegre
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2012-02
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Everolimus Small molecule
Comparator Tacrolimus Small molecule