drugset / Trial / NCT00895583

Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients

NCT00895583 ↗

Phase 4 Completed 254 enrolled Pfizer
RandomizedParallel-groupOpen-labelPrevention

Summary

This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.

Timeline

Start
2009-06
Primary completion
2013-08
Completion
2013-08

Outcome

Missed primary endpoint

registry Sirolimus vs Tacrolimus; p = 0.239; Odds Ratio (OR) 0.7 (95% CI 0.4 to 1.3) NCT00895583 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sirolimus Small molecule — Oral
Comparator Tacrolimus Small molecule — —

Indications