Overview

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.