CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 245 enrolled
Drug / intervention
CsA+Rapamune+CS +1 moredrug
Likely dose
CsA+Rapamune+CS 6 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/NCT01601821
NCT01601821Phase 4Completed
CompareCT.gov

An Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids With Further CSA Elimination In The Rapamune Arm With The Introduction Of MMF

Pfizer·interventional·Posted May 18, 2012·Updated Dec 12, 2018

In Brief

A Phase 4 clinical trial evaluating CsA+Rapamune+CS and CsA+MMF+CS for Inflammation. Completed, enrolled 245 participants across 4 sites.

Detailed Summary

To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft recipients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInflammation
CountriesIran
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 18, 2012
Enrollment StartApr 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.1 years ago

Interventions

CsA+Rapamune+CSdrug

Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months

CsA+MMF+CSdrug

The control arm is the standard local practice (official protocol) in Iran: Cyclosporine + MMF + Corticosteroid. The time period is from pre-study screening / baseline evaluation up to 12 months for patients who are maintained on CsA + MMF + CS.