Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

End Stage Renal Disease Clinical Trial

— GenTac  

Official title:

Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698541
• Other study ID #: GenTac-12
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2012
• Last updated: December 2, 2014
• Start date: February 2013
• Est. completion date: November 2013

Study information

• Verified date: December 2014
• Source: University of Oslo School of Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT01798758

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Tacrolimus
Tested generic
• Tacrolimus
Original formulation used as comparator

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Rikshospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo School of Pharmacy	Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioequivalence	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.	10 weeks	Yes
Secondary	Population model validation	Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.	10 weeks	No