Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
Information source: University of Oslo School of Pharmacy
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease
Intervention: Tacrolimus (Drug); Tacrolimus (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Oslo School of Pharmacy Official(s) and/or principal investigator(s): Anders Ã…sberg, PhD, Study Chair, Affiliation: University of Oslo
Summary
Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as
comparator, in elderly (>60 yr) renal transplant recipients
Clinical Details
Official title: Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bioequivalence
Secondary outcome: Population model validation
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.
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Oslo University Hospital, Rikshospitalet, Oslo 0027, Norway
Additional Information
Starting date: February 2013
Last updated: December 2, 2014
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