Generic Tacrolimus in the Elderly - Prograf® vs Tacni® (GenTac)
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Tacrolimus
Tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Renal, Transplantation, Elderly
Eligibility 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.
Sites / Locations
- Oslo University Hospital, Rikshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tacni
Prograf
Arm Description
Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center
Tacrolimus administered as Prograf in according to standard protocol at the transplant center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Population model validation
Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.
Full Information
NCT ID
NCT01698541
First Posted
September 21, 2012
Last Updated
December 2, 2014
Sponsor
University of Oslo School of Pharmacy
Collaborators
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01698541
Brief Title
Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
Acronym
GenTac
Official Title
Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo School of Pharmacy
Collaborators
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Renal, Transplantation, Elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tacni
Arm Type
Experimental
Arm Description
Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center
Arm Title
Prograf
Arm Type
Active Comparator
Arm Description
Tacrolimus administered as Prograf in according to standard protocol at the transplant center
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Tacrolimus formualted as the generic Tacni
Intervention Description
Tested generic
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Tacrolimus formualted as the original Prograf
Intervention Description
Original formulation used as comparator
Primary Outcome Measure Information:
Title
Bioequivalence
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Population model validation
Description
Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Åsberg, PhD
Organizational Affiliation
University of Oslo
Official's Role
Study Chair
Facility Information:
Facility Name
Oslo University Hospital, Rikshospitalet
City
Oslo
ZIP/Postal Code
0027
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
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