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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
University of Oslo School of Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Renal, Transplantation, Elderly

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 21, 2012
Last Updated
December 2, 2014
Sponsor
University of Oslo School of Pharmacy
Collaborators
Oslo University Hospital
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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

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Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

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