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A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients

NCT ID: NCT00282256

Last Updated: 2013-10-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2008-10-31

Brief Summary

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A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Detailed Description

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A 1 arm study to assess the pharmacokinetics, and long-term safety and effectiveness of a modified release tacrolimus based immunosuppression regimen in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen.

Conditions

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Liver Transplantation

Keywords

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Child Pharmacokinetics Immunosuppression Drugs Hepatic transplant Liver Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Tacrolimus MR

Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.

Group Type EXPERIMENTAL

tacrolimus modified release (MR)

Intervention Type DRUG

Oral

tacrolimus

Intervention Type DRUG

Oral

Interventions

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tacrolimus modified release (MR)

Oral

Intervention Type DRUG

tacrolimus

Oral

Intervention Type DRUG

Other Intervention Names

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Advagraf, FK506E, MR4, FKMR, Astagraf XL Prograf, FK506

Eligibility Criteria

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Inclusion Criteria

* Patient is currently receiving Prograf® based immunosuppressive therapy for liver transplantation.
* Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable

Exclusion Criteria

* Patient has previously received an organ transplant other than a liver
* Patient is currently receiving sirolimus immunosuppression therapy.
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Atlanta, Georgia, United States

Site Status

Indianapolis, Indiana, United States

Site Status

New Orleans, Louisiana, United States

Site Status

New York, New York, United States

Site Status

Madison, Wisconsin, United States

Site Status

Countries

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United States

References

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Heffron TG, Pescovitz MD, Florman S, Kalayoglu M, Emre S, Smallwood G, Wisemandle K, Anania C, Dhadda S, Sawamoto T, Keirns J, Fitzsimmons W, First MR. Once-daily tacrolimus extended-release formulation: 1-year post-conversion in stable pediatric liver transplant recipients. Am J Transplant. 2007 Jun;7(6):1609-15. doi: 10.1111/j.1600-6143.2007.01803.x.

Reference Type BACKGROUND
PMID: 17511684 (View on PubMed)

Other Identifiers

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03-0-160

Identifier Type: -

Identifier Source: org_study_id