CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 828 enrolled
Drug / intervention
Everolimus +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01114529
NCT01114529Phase 3Completed
CompareCT.gov

A 24-month, Multi-center, Open-label, Randomized, Controlled Trial to Investigate Efficacy, Safety and Evolution of Cardiovascular Parameters in de Novo Renal Transplant Recipients After Early Calcineurin Inhibitor to Everolimus Conversion

Novartis Pharmaceuticals·interventional·Posted May 3, 2010·Updated May 30, 2017

In Brief

A Phase 3 clinical trial evaluating Everolimus and Prograf or Neoral for Kidney Transplantation. Completed, enrolled 828 participants across 77 sites in 21 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Transplantation
CountriesArgentina, Australia, Austria, Belgium, Estonia, France, Germany, Greece, India, Italy, Latvia, Lithuania, Mexico, Netherlands, Norway, Portugal, Romania, Russia, Spain, Thailand, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 3, 2010
Enrollment StartAug 9, 2010
Primary CompletionOct 30, 2014
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.2 years ago

Interventions

Everolimusdrug

Early CNI to everolimus conversion

Prograf or Neoraldrug

Active CNI-based control (Prograf or Neoral)