CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Everolimus + Cyclosporine +2 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/NCT00425308
NCT00425308Phase 3Completed

A Prospective Multicenter Open-label Randomized Study to Assess Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus Without Calcineurine Inhibitor in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

Novartis Pharmaceuticals·interventional·Posted Jan 22, 2007·Updated Mar 30, 2017

In Brief

A Phase 3 clinical trial evaluating Everolimus + Cyclosporine, Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS), and 1 other intervention for Renal Transplantation. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 22, 2007
Enrollment StartOct 1, 2006
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 19.4 years ago

Interventions

Everolimus + Cyclosporinedrug

Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)drug

Steroidsdrug