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Generic Tacrolimus in the Elderly - Prograf® vs Tacni®

NCT ID: NCT01698541

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tacni

Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

Tested generic

Tacrolimus

Intervention Type DRUG

Original formulation used as comparator

Prograf

Tacrolimus administered as Prograf in according to standard protocol at the transplant center

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

Tested generic

Tacrolimus

Intervention Type DRUG

Original formulation used as comparator

Interventions

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Tacrolimus

Tested generic

Intervention Type DRUG

Tacrolimus

Original formulation used as comparator

Intervention Type DRUG

Other Intervention Names

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Tacrolimus formualted as the generic Tacni Tacrolimus formualted as the original Prograf

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role collaborator

University of Oslo School of Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Anders Åsberg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anders Åsberg, PhD

Role: STUDY_CHAIR

University of Oslo

Locations

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Oslo University Hospital, Rikshospitalet

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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GenTac-12

Identifier Type: -

Identifier Source: org_study_id

NCT01798758

Identifier Type: -

Identifier Source: nct_alias