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

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ClinicalTrials.gov Identifier: NCT01698541
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Anders Åsberg, University of Oslo School of Pharmacy

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

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: Tacrolimus Phase 4

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  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Generic Tacrolimus in the Elderly - Prograf® vs Tacni®
Study Start Date : February 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

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 Name: Tacrolimus formualted as the generic Tacni
Drug: Tacrolimus
Original formulation used as comparator
Other Name: 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 Name: Tacrolimus formualted as the generic Tacni
Drug: Tacrolimus
Original formulation used as comparator
Other Name: Tacrolimus formualted as the original Prograf



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Population model validation [ Time Frame: 10 weeks ]
    Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.



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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698541


Locations
Norway
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Oslo University Hospital
Investigators
Study Chair: Anders Åsberg, PhD University of Oslo

Responsible Party: Anders Åsberg, Professor, University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier: NCT01698541     History of Changes
Obsolete Identifiers: NCT01798758
Other Study ID Numbers: GenTac-12
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Anders Åsberg, University of Oslo School of Pharmacy:
Renal
Transplantation
Elderly

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action