A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00282243

First received: January 24, 2006

Last updated: November 10, 2011

Last verified: November 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 24, 2006

Last Updated Date

November 10, 2011

Start Date ^ICMJE

February 2003

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetics [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00282243 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Long-term safety and tolerability [ Time Frame: 8 weeks treatment then extension treatment period until commercially available or notified by Astellas Pharma Inc. ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients

Official Title ^ICMJE

A Phase 2, Open-Label, Multi-Center Study to Assess the Pharmacokinetics, Long-term Safety and Tolerability of Tacrolimus in Stable Liver Transplant Patients Converted From a Prograf® Based Immunosuppression Regimen to a Modified Release (MR) Tacrolimus Based Immunosuppression Regimen

Brief Summary

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

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Liver Transplantation

Intervention ^ICMJE

Drug: tacrolimus modified release (MR)
Oral

Other Name: Advagraf, FK506E-MR, MR4, FKMR
Drug: tacrolimus
Oral

Other Name: Prograf, FK506

Study Arm (s)

Experimental: 1

Interventions:

Drug: tacrolimus modified release (MR)
Drug: tacrolimus

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00282243

Other Study ID Numbers ^ICMJE

02-0-152

Has Data Monitoring Committee

Responsible Party

Astellas Pharma Inc

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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