At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 833 enrolled

Drug / intervention

Everolimus +4 moredrug

Likely dose

Mycophenolic Acid (MPA) 360mgfrom 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/NCT00251004

NCT00251004Phase 3Completed

Compare CT.gov

Efficacy and Safety Study Comparing Concentration-controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients

Novartis·interventional·Posted Nov 9, 2005·Updated May 10, 2011

In Brief

A Phase 3 clinical trial evaluating Everolimus, Mycophenolic Acid (MPA), and 3 other interventions for Kidney Transplantation and Graft Rejection. Completed, enrolled 833 participants across 1 site.

Detailed Summary

The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsKidney Transplantation, Graft Rejection

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartOct 2005

First PostedNov 2005

Primary CompletionAug 2009

Study CompletionOct 2009

TodayJul 2026

First PostedNov 9, 2005

Enrollment StartOct 1, 2005

Primary CompletionAug 1, 2009

Study CompletionOct 1, 2009

TodayJul 2, 2026

Enrollment to primary: 3.8 yearsPosted 20.6 years ago

Interventions

Everolimusdrug

oral, bis in diem/twice a day (bid)

Mycophenolic Acid (MPA)drug

2 oral capsules of mycophenolic acid 360mg administered bid

Cyclosporine A (CsA)drug

CsA dose adjustments were based on CsA trough levels (C0).

Basiliximabdrug

All patients received two 20 mg doses of basiliximab administered intravenously. The first dose was to be given within 2 hours prior to transplant surgery and the second dose was to be administered on day 4, or each dose could have been administered according to local practice.

Corticosteroidsdrug

Oral corticosteroids were administered according to local practice during the trial. At the same center, all patients were to follow the same steroid administration protocol.