A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.
A three sequence, open-label, multi-center, prospective, study in stable kidney transplant patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules. Stable kidney transplant patients who fulfill all I/E criteria will be enrolled and kept on Prograf for 7 days. Following a 24-hour PK study on Day 7 to determine pharmacokinetics for Prograf, all patients will be converted to once daily LCP-Tacro for 7 days with no dose changes allowed. On Day 14 and Day 21 a 24-hour LCP-Tacro PK study will be performed. On Day 22 patients will be converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days ending with a safety assessment on day 53.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
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.
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.
University of Cincinnati
Cincinnati, Ohio, United States
Methodist Hospital Houston
Houston, Texas, United States
Evaluation of Steady State Tacrolimus Trough Levels (C24).
Patients had a baseline trough level (C24) measured at day 7 before conversion to LCP-Tacro.
Time frame: 7 days
Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
Patients had a baseline AUC measured (0 to 24 hours) at day 7 before conversion to LCP-Tacro.
Time frame: 7 days
Evaluation of Steady State Tacrolimus Exposure Trough Levels (C24).
Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, a trough level (C24) was measured.
Time frame: 21 days
Evaluation of Steady State Tacrolimus Exposure (AUC 0-24).
Patients were converted from Prograf to LCP-Tacro on day 7. On day 21, AUC was measured (0 to 24 hours).
Time frame: 21 days
Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 21.
Cmax and Cavg was measured at day 21 (Cmin was measured as part of the primary outcome).
Time frame: 21 days
Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 21.
Tmax was measured at day 21 (Cmin was measured as part of the primary outcome).
Time frame: 21 days
Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 21.
Degree og fluctuation and degree of swing was measured at day 21 (Cmin was measured as part of the primary outcome).
Time frame: 21 days
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Tacrolimus Pharmacokinetics (Cmax and Cavg) Was Measured at Day 7.
Cmax and Cavg was measured at baseline day 7 (Cmin was measured as part of the primary outcome).
Time frame: 7 days
Tacrolimus Pharmacokinetics (Tmax) Was Measured at Day 7.
Tmax was measured at baseline day 7 (Cmin was measured as part of the primary outcome).
Time frame: 7 days
Tacrolimus Pharmacokinetics (Fluctuation and Swing) Was Measured at Day 7.
Degree og fluctuation and degree of swing was measured as baseline at day 7 (Cmin was measured as part of the primary outcome).
Time frame: 7 days
Safety Evaluation
A combination of deaths, graft failure and biopsy proven acute rejections (BPAR) was used to evaluate the safety.
Time frame: 52 days