Primary Outcome Measures:
- Evaluation of steady state tacrolimus exposure (AUC 0-24) and trough levels (C24) in stable kidney transplant recipients converted from Prograf® (tacrolimus, Astellas Pharma US, Inc.) to LCP-Tacro in a three sequence study design. [ Time Frame: 22 days ]
Secondary Outcome Measures:
- To determine whether patients can be safely converted from Prograf to LCP-Tacro [ Time Frame: 52 days ]
- To evaluate tacrolimus exposure and trough concentrations in stable kidney transplant recipients converted from Prograf to LCP-Tacro in a three-sequence study design [ Time Frame: 22 days ]
- To determine the mean conversion ratio between Prograf twice-a-day and LCP Tacro once-a-day [ Time Frame: 22 days ]
- To evaluate the safety of LCP-Tacro compared to Prograf [ Time Frame: 52 days ]
Intervention Details:
Drug: LCP Tacro-2011
Once-daily 1 mg, 2 mg, and 5 mg tablets
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.