Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

Phase 4

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: Tacrolimus

• Registration Number: NCT01698541
• Lead Sponsor: University of Oslo School of Pharmacy

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-03
• Study Start: 2013-02
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

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Exclusion Criteria

• Diabetes mellitus (WHO criteria).
• Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tacni	Tacrolimus	Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center
Prograf	Tacrolimus	Tacrolimus administered as Prograf in according to standard protocol at the transplant center

Primary Outcome Measures

Name	Time	Method
Bioequivalence	10 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Population model validation	10 weeks	Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.

Trial Locations

Locations (1)

Oslo University Hospital, Rikshospitalet; 🇳🇴 Oslo, Norway