A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients - Full Text View

Purpose

Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

Condition	Intervention	Phase
Transplantation	Drug: Tacrolimus	Phase III

MedlinePlus related topics:

Liver Transplantation

Drug Information available for:

Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Open, Single Sequence Crossover Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Stable Liver Transplant Patients Converted From a Prograf® Based Immunosuppressive Regimen

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Creatinine clearance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Blood pressure, HbA1c, Acute rejection episodes [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	106
Study Start Date:	October 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Tacrolimus Immunosuppression

Detailed Description:

Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered twice daily is replaced by Prograf as study medication, administered twice daily.

Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements (see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment.

Conversion from Prograf (twice daily, morning & evening dosing) total daily dose to MR4 once daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1.

Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Liver transplant at least 12 months prior to enrollment.
Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.

Exclusion Criteria:

Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384202

Locations


France

	Lyon, France, 69437

	Strasbourg, France, 67098

	Villejuif, France, 94801

Germany

	Berlin, Germany, 13353

	Hamburg, Germany, 20251

Ireland

	Dublin, Ireland, Dublin 4

Poland

	Warszawa, Poland, 02-005

Spain

	Barakaldo, Spain, 48903

	Barcelona, Spain, 08035

	Santiago de Compostela, Spain, 15706

	Sevilla, Spain, 41013

	Valencia, Spain, 46009

United Kingdom

	Birmingham, United Kingdom, B15 2TH

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Director:	Use Central Contact	Astellas Pharma GmbH

More Information

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	PMR-EC-1105
First Received:	October 4, 2006
Last Updated:	December 31, 2007
ClinicalTrials.gov Identifier:	NCT00384202
Health Authority:	France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ireland: Irish Medicines Board; Poland: Ministry of Health; Spain: Spanish Agency of Medicines

Keywords provided by Astellas Pharma Inc:

Tacrolimus

Liver Transplantation

Study placed in the following topic categories:

Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00384202