Pharmacokinetics and Clinical Outcomes of Generic Tacrolimus (Hexal) Versus Branded Tacrolimus in De Novo Kidney Transplant Patients: A Multicenter, Randomized Trial.

Background: Scrupulous comparison of the pharmacokinetic and clinical characteristics of generic tacrolimus formulations versus the reference drug (Prograf) is essential. Pharmacokinetics of the TacHexal formulation are similar to Prograf in stable renal transplant patients but data in de novo patients is lacking. Methods: De novo kidney transplant patients were randomized to generic tacrolimus (Tacrolimus Hexal [TacHexal]) or Prograf in a 6-month open-label study. Results: The primary endpoint, the dose-normalized AUC0-12h ratio at month 1 posttransplant, was similar with TacHexal or Prograf: back-transformed geometric means of adjusted log-transformed values (ANOVA) were 18.99 ng*h/L (TacHexal) and 20.48 ng*h/L (Prograf) (ratio 1.08 [90% CI 0.84; 1.38]; p=0.605). The dose-normalized peak concentration (Cmax) geometric means at month 1 was also comparable between treatments (ratio 1.16 [90% CI 0.88; 1.54], p=0.377). There were no relevant differences in other pharmacokinetic parameters at month 1, or in AUC0-4 and trough concentration when measured at months 3 and 6. The adjusted change in mean estimated GFR from baseline to month 6 (Nankivell) was noninferior for TacHexal versus Prograf using observed values (47.7 versus 38.6mL/min/1.73m2, p

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