CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,037 enrolled
Drug / intervention
Induction therapy +3 morebiological
Likely dose
Corticosteroids 5 mgfrom 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/NCT01950819
NCT01950819Phase 4Completed
CompareCT.gov

A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation

Novartis Pharmaceuticals·interventional·Posted Sep 26, 2013·Updated Jan 30, 2019

In Brief

A Phase 4 clinical trial evaluating Induction therapy, Corticosteroids, and 2 other interventions for End Stage Renal Disease (ESRD) and 4 related conditions. Completed, enrolled 2,037 participants across 184 sites in 42 countries.

Detailed Summary

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease (ESRD), Chronic Kidney Disease (CKD), Hemodialysis, Renal Replacement Therapy, Renal Transplantation
CountriesArgentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, Colombia, Croatia, Czechia, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 26, 2013
Enrollment StartDec 3, 2013
Primary CompletionFeb 1, 2017
Study CompletionJan 17, 2018
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 12.8 years ago

Interventions

Induction therapybiological

All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.

Corticosteroidsdrug

All subjects received maintenance therapy with corticosteroids throughout the 24 month study period. A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.

EVR+rCNIdrug

Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)

MPA+sCNIdrug

Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).