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OpenTrials
Completed

NCT Number: NCT01698541

Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

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

Completed

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oslo University Hospital, Rikshospitalet

Oslo, 0027, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus

Drug

Tested generic

Other names: Tacrolimus formualted as the generic Tacni

Primary outcomes

  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 outcomes

  1. Population model validation

    Time frame: 10 weeks

    Use these new patient data to verify previously developed population pharmacokinetic model for tacrolimus.

Sponsors and collaborators

Lead sponsor

University of Oslo School of Pharmacy

Other

Collaborators

  • Oslo University Hospital

Registry information

Acronym: GenTac

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 3, 2012
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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