Generic Tacrolimus in the Elderly - Prograf® vs Tacni® (GenTac)

University of Oslo School of Pharmacy

Status and phase: Completed; Phase 4

Conditions: End Stage Renal Disease

Treatments: Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT01698541

GenTac-12

Details and patient eligibility

About

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

Full description

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.

Enrollment: 28 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Tacni

Experimental group

Description:

Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center

Treatment:

Drug: Tacrolimus

Drug: Tacrolimus

Prograf

Active Comparator group

Description:

Tacrolimus administered as Prograf in according to standard protocol at the transplant center

Treatment:

Drug: Tacrolimus

Drug: Tacrolimus