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

PHASE3CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

August 31, 2012

Study Completion Date

July 31, 2015

Conditions
Renal FailureTremors
Interventions
DRUG

Prograf

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.

DRUG

LCP-Tacro

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.

Trial Locations (10)

37232

Clinical Investigative Site 009, Nashiville

40536

Clinical Investigative Site 004, Lexington

55455

Clinical Investigative Site 008, Minneapolis

63110

Clinical Investigative Site 003, St Louis

73112

Clinical Investigative Site 002, Oklahoma City

75246

Clinical Investigative Site 012, Dallas

80045

Clinical Investigative Site 007, Aurora

90057

Clinical Investigative Site 006, Los Angeles

92123

Clinical Investigative Site 1049, San Diego

06520

Clinical Investigative Site 005, New Haven

Sponsors
All Listed Sponsors
lead

Veloxis Pharmaceuticals

INDUSTRY

NCT01438710 - Switching Study of Kidney Transplant Patients With Tremor to LCP-Tacro (STRATO) | Biotech Hunter | Biotech Hunter