drugset / Trial / NCT01114529

Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients

NCT01114529

Phase 3 Completed 828 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to determine whether an early Calcineurin Inhibitor (CNI) to everolimus conversion at 10-14 weeks post transplantation improves renal allograft function without compromising efficacy compared to standard CNI treatment in de novo renal allograft recipients. In addition, the study was designed to evaluate the impact of a CNI-free regimen on evolution of cardiovascular parameters in de novo renal allograft recipients

Timeline

Start
2010-08-09
Primary completion
2014-10-30
Completion
2014-10-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclosporine Peptide
Subject Everolimus Small molecule
Comparator Tacrolimus Small molecule

Indications

No indication recorded.