Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)

Summary

This study will evaluate and measure symptomatic hand tremor in stable kidney transplant subjects on Prograf or generic tacrolimus maintenance therapy at baseline (pre-conversion) and following conversion to LCP-Tacro. This study will also evaluate the safety of LCP-Tacro compared with Prograf or generic tacrolimus

Timeline

Start

2011-12

Primary completion

2012-08

Completion

2015-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); LCP-Tacro; p = 0.0048; t-test, 2 sided NCT01438710 ↗

Drugs

Indications