Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

University of Oslo School of Pharmacy28 enrolled

Overview

Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (\>60 yr) renal transplant recipients

12-hour pharmacokinetic investigations performed on each formulation in each patient at steady-state. Patients will be randomized with regards to which formulation to start with. 1-2 weeks between each PK investigation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

TacrolimusDRUG

Tested generic

TacrolimusDRUG

Original formulation used as comparator

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Renal transplant recipients that will receive Tac as part of their immunosuppressive therapy. * Recipients 60 years of age or older. * Signed informed consent. Exclusion Criteria: * Diabetes mellitus (WHO criteria). * Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.

Locations (1)

Oslo University Hospital, Rikshospitalet

Oslo, Norway

Outcomes

Primary Outcomes

Bioequivalence

Bioequivalence will be assessed at steady-state by comparing both AUC(0-12) and Cmax ratios for generic:original-ratios and applying the stricter 90-111% bioequivalence criteria. AUC(0-12) will be assessed by trapezoidal rule and Cmax will be the highest actually measured concentration.

Time frame: 10 weeks

Secondary Outcomes

Population model validation

Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.

Time frame: 10 weeks

Data from ClinicalTrials.gov

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