Kidney Transplant; Complications Clinical Trial
Official title:
Conversion Pharmacodynamic Study in Stable Renal Transplant Patients Receiving Tacrolimus Two Times a Day to a New Formulation of Tacrolimus - LCP Tacro - 1 Time a Day.
LCP-Tacro is an extended-release formulation of tacrolimus designed for once-daily dosing.
Phase 1 studies demonstrated greater bioavailability than twice-daily tacrolimus capsules and
no new safety concerns.
- Stable kidney transplant patients can be safely converted from Adoport® twice-daily to
LCP-Tacro®.
- The greater bioavailability of LCP-Tacro after once-daily dosing results in similar
(AUC) exposure, at a dose approximately 30% less, than the total daily dose of Adoport®.
- LCP-Tacro provides a slow drug release and this results in flatter kinetics
characterized by significantly lower peak-trough fluctuations.
- CN is the major cellular target of the calcineurin inhibitors (CNIs) cyclosporine A
(CsA) and tacrolimus. The ability of these drugs to inhibit CN activity is dependent on
their binding to the respective immunophilins, cyclophilins A and B for CsA and FKBP12
for tacrolimus.
- CN inhibition is a rate limiting phenomenon. Over concentrations of tacrolimus does not
correlate with an increase in the CN activity.
n/a
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