Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily

PHASE3CompletedINTERVENTIONAL
Enrollment

326

Participants

Timeline

Start Date

December 31, 2008

Primary Completion Date

February 28, 2011

Study Completion Date

February 28, 2011

Conditions
Renal Failure
Interventions
DRUG

LCP-Tacro

LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets.

DRUG

Prograf

Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules.

Trial Locations (1)

92123

California Institute of Renal Research/ Sharp Memorial, San Diego

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

Veloxis Pharmaceuticals

INDUSTRY

NCT00817206 - Safety and Efficacy of LCP-Tacro™ Once Daily in Stable Renal Transplant Patients Converted From Prograf® Twice Daily | Biotech Hunter | Biotech Hunter