CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 47 enrolled
Drug / intervention
Tacrolimus +2 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓End-stage renal disease with scheduled kidney transplant
  • ✓Women of childbearing potential must use medically acceptable contraception and not be pregnant
  • ✓Signed informed consent required
Key exclusion· 3
  • ✕Active systemic or localized major infection at time of study drug initiation
  • ✕Multiple organ transplants
  • ✕Any pathology or medical condition that interferes with protocol compliance

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

Search/NCT00195429
NCT00195429Phase 4Completed
CompareCT.gov

A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients

Wyeth is now a wholly owned subsidiary of Pfizer·interventional·Posted Sep 19, 2005·Updated Dec 11, 2023

In Brief

A Phase 4 clinical trial evaluating Tacrolimus, Sirolimus, and 1 other intervention for Kidney Failure and Graft vs Host Disease. Completed, enrolled 47 participants across 1 site.

Detailed Summary

This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Failure, Graft vs Host Disease
CountriesBrazil
Collaborators--

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartAug 1, 2005
Study CompletionOct 1, 2007
TodayJul 2, 2026
Posted 20.8 years ago

Interventions

Tacrolimusdrug

Sirolimusdrug

prednisonedrug