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

This study has been completed.
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Anders Åsberg, University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT01698541
First received: September 21, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
End Stage Renal Disease
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

Resource links provided by NLM:


Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:
  • Bioequivalence [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.


Estimated Enrollment: 26
Study Start Date: February 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacni
Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center
Drug: Tacrolimus
Other Name: Tacrolimus formualted as the generic Tacni
Active Comparator: Prograf
Tacrolimus administered as Prograf in according to standard protocol at the transplant center
Drug: Tacrolimus
Other Name: Tacrolimus formualted as the generic Tacni

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698541

Locations
Norway
Oslo University Hospital, Rikshospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Oslo University Hospital
  More Information

No publications provided

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
Study First Received: September 21, 2012
Last Updated: December 9, 2013
Health Authority: Norway: Norwegian Medicines Agency

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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014