Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

March 31, 2008

Study Completion Date

March 31, 2008

Conditions
Renal Failure
Interventions
DRUG

LCP Tacro (tacrolimus)

"Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.~Other Names:~Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets."

DRUG

Prograf

"Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.~Other Names:~Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets."

Trial Locations (2)

45267

University of Cincinnati, Cincinnati

77030

Methodist Hospital Houston, Houston

All Listed Sponsors
collaborator

CTI Clinical Trial and Consulting Services

OTHER

lead

Veloxis Pharmaceuticals

INDUSTRY