CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 71 enrolled
Drug / intervention
Everolimus +2 moredrug
Likely dose
Everolimus 1.0 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/NCT01169701
NCT01169701Phase 4Completed
CompareCT.gov

Multicenter, Open-label, Randomized, 24 Months Follow-up, Two Arm Study to Compare the Efficacy of Everolimus in Improving the Cardiovascular Profile in a Regimen With Mycophenolic Acid vs. a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients.

Novartis Pharmaceuticals·interventional·Posted Jul 26, 2010·Updated Dec 7, 2015

In Brief

A Phase 4 clinical trial evaluating Everolimus, Tacrolimus, and 1 other intervention for Renal Transplant. Completed, enrolled 71 participants across 9 sites.

Detailed Summary

The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant patients

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplant
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2010
Enrollment StartAug 1, 2010
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 15.9 years ago

Interventions

Everolimusdrug

Everolimus was supplied in boxes with 60 tablets. Available tablets: 1.0 mg, 0.5 mg and 0.25 mg.

Tacrolimusdrug

Tacrolimus was administrated as Prograf® or Advagraf®, but could not be changed during study.

Mycophenolic acid (MPA)drug

Myfortic® (MFS) was given as 720-1440 mg/day or 360-1440 mg/day. Cell-Cept® (MMF) was given as 1000-2000 mg/day or 500-2000 mg/day.