Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00481481

Purpose

Assessment of the safety and the efficacy of a tacrolimus modified release (FK506MR) based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen.

Condition	Intervention	Phase
Transplantation	Drug: tacrolimus	Phase III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Cyclosporin Cyclosporine 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, SINGLE-ARM, OPEN, CONVERSION STUDY FROM A CYCLOSPORINE (CyA) BASED IMMUNOSUPPRESSIVE REGIMEN TO A TACROLIMUS MODIFIED RELEASE, FK506MR, BASED IMMUNOSUPPRESSIVE REGIMEN IN KIDNEY TRANSPLANT SUBJECTS

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change in creatinine clearance, calculated according to Cockcroft and Gault formula. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in creatinine clearance, calculated according to Cockcroft and Gault formula, between Baseline (Day 1) and week 24 (End of Study) overall [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Rating of subjects according to reason for conversion: Changes in mean lipid levels (total cholesterol) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment:	380
Study Start Date:	April 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: tacrolimus immunosuppression

Detailed Description:

Multicenter, single-arm, open phase IIIb, conversion study where a Cyclosporine A-based immunosuppressive regimen is replaced by the administration of tacrolimus modified release formulation, MR4, once daily (morning dosing only) in stable renal transplant subjects. The initial recommended dose of MR4 is 0.1 mg/kg/day.

Twenty-four weeks of treatment on MR4-based immunosuppressive regimen is considered to be an appropriate study duration in order to assess the response in subjects suffering from one or more known cyclosporine side effects, hypertrichosis/hirsutism, gingival hyperplasia, hyperlipidemia, arterial hypertension.

Stable, adult kidney transplant recipients (≥ 12 months post transplant) who are currently treated with cyclosporine and who meet the Inclusion and Exclusion Criteria will be enrolled.

Eligibility

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

Criteria

Inclusion Criteria:

Serum creatinine < 200 µmol/l (< 2.3 mg/dl) at enrollment.
Female subject of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study.
Capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent (signed Informed Consent has been obtained).

Exclusion Criteria:

Previously received an organ transplant other than a kidney.
Acute rejection episode within 12 weeks prior to enrollment, or an acute rejection episode within the 24 weeks prior to enrollment that required anti-lymphocyte antibody therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481481

Contacts

Contact: Clinical Research Transplantation Unit

+49 89 4544 2213

Show 57 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Central Contact

Astellas Pharma GmbH

More Information

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	PMR-EC-1209
Study First Received:	May 30, 2007
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00481481
Health Authority:	Austria: Federal Ministry for Health and Women; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Czech Republic: State Institute for Drug Control; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Poland: Ministry of Health; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Switzerland: Swissmedic

Keywords provided by Astellas Pharma Inc:

Tacrolimus, Kidney Transplantation

Study placed in the following topic categories:

Cyclosporine
Tacrolimus
Cyclosporins

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009