Generic Tacrolimus in the Elderly - Prograf® vs Tacni® (GenTac)

December 2, 2014 updated by: Anders Åsberg, University of Oslo School of Pharmacy
Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (>60 yr) renal transplant recipients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • Oslo University Hospital, Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tacni
Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center
Drug: Tacrolimus
Tested generic
Other Names:
  • Tacrolimus formualted as the generic Tacni
Drug: Tacrolimus
Original formulation used as comparator
Other Names:
  • Tacrolimus formualted as the original Prograf
ACTIVE_COMPARATOR: Prograf
Tacrolimus administered as Prograf in according to standard protocol at the transplant center
Drug: Tacrolimus
Tested generic
Other Names:
  • Tacrolimus formualted as the generic Tacni
Drug: Tacrolimus
Original formulation used as comparator
Other Names:
  • Tacrolimus formualted as the original Prograf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioequivalence
Time Frame: 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.
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Population model validation
Time Frame: 10 weeks
Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo School of Pharmacy

Collaborators

Oslo University Hospital

Investigators

  • Study Chair: Anders Åsberg, PhD, University of Oslo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

September 21, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (ESTIMATE)

October 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GenTac-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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