a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients

NCT ID: NCT01055964

Last Updated: 2015-05-27

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

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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The aim of this study is to identify the pharmacokinetic differences between two oral forms of Tacrolimus and consequent nephrotoxicity.

Detailed Description

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Conditions

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Pharmacokinetics Tacrolimus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Tacrobell

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

Prograf

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type DRUG

Interventions

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Tacrolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ABO-compatible renal transplant recipients

Exclusion Criteria

* multi-organ transplant
* HIV(+) donor or recipients
* history of malignancy other than skin cancer (except completely cured basal cell ca or squamous cell ca)
* more than three-fold increase in AST or ALT level for 28 days
* pregnancy
* lactation
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jongwon Ha

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jongwon Ha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Tacrobell-01

Identifier Type: -

Identifier Source: org_study_id

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