CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 44 enrolled
Drug / intervention
Prograf +1 moredrug
Likely dose
Not stated in 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/NCT01438710
NCT01438710Phase 3Completed
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Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO)

Veloxis Pharmaceuticals·interventional·Posted Sep 22, 2011·Updated Oct 1, 2015

In Brief

A Phase 3 clinical trial evaluating Prograf and LCP-Tacro for Renal Failure and Tremors. Completed, enrolled 44 participants across 10 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure, Tremors
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 22, 2011
Enrollment StartDec 1, 2011
Primary CompletionAug 1, 2012
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.8 years ago

Interventions

Prografdrug

Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.

LCP-Tacrodrug

LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.