End Stage Renal Disease
Conditions
Keywords
Renal, Transplantation, Elderly
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.
Interventions
DRUGTacrolimus
Tested generic
Sponsors
Oslo University Hospital
University of Oslo School of Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Population model validation | 10 weeks | Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus. |
Countries
Norway
Outcome results
None listed