Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oslo School of Pharmacy
• Collaborator: Oslo University Hospital
• Treatments: Tacrolimus

Criteria

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.