CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 830 enrolled
Drug / intervention
Sirolimus +2 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Age 13 years or older
  • ✓Currently receiving cyclosporine A or tacrolimus from time of transplantation or within 2 weeks thereafter
  • ✓Functioning allograft with Nankivell GFR ≥20 mL/min within 2 weeks before randomization
Key exclusion· 2
  • ✕Biopsy-confirmed acute rejection within 12 weeks before randomization requiring antirejection treatment
  • ✕Kidney-pancreas or other multiple organ transplant recipients

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00038948
NCT00038948Phase 3Completed
CompareCT.gov

A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Jun 7, 2002·Updated May 14, 2010

In Brief

A Phase 3 clinical trial evaluating Sirolimus, tacrolimus, and 1 other intervention for Renal Transplantation. Completed, enrolled 830 participants.

Detailed Summary

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Transplantation
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 7, 2002
Enrollment StartJan 1, 2002
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 24.1 years ago

Interventions

Sirolimusdrug

Sirolimus, Cyclosporine A \& Tacrolimus are concentration controlled

tacrolimusdrug

Cyclosporine Adrug