Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects (CONCERTO)

This study has been completed.

Sponsor:

Information provided by:

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00481481

First received: May 30, 2007

Last updated: May 12, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 30, 2007

Last Updated Date

May 12, 2009

Start Date ^ICMJE

April 2007

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Change in creatinine clearance, calculated according to Cockcroft and Gault formula.

Change History

Complete list of historical versions of study NCT00481481 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

• Change in creatinine clearance, calculated according to Cockcroft and Gault formula, between Baseline (Day 1) and week 24 (End of Study) overall. • Rating of subjects according to reason for conversion:  Changes in mean lipid levels (total chol

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects

Official Title ^ICMJE

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

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Transplantation

Intervention ^ICMJE

Drug: tacrolimus

immunosuppression

Other Names:

Advagraf
FK506MR
MR4

Study Arm (s)

Experimental: 1

Intervention: Drug: tacrolimus

Publications *

Rostaing L, Sánchez-Fructuoso A, Franco A, Glyda M, Kuypers DR, Jaray J. Conversion to tacrolimus once-daily from ciclosporin in stable kidney transplant recipients: a multicenter study. Transpl Int. 2012 Apr;25(4):391-400. doi: 10.1111/j.1432-2277.2011.01409.x. Epub 2011 Dec 27.

* 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

346

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Poland, Spain, Sweden, Switzerland

Administrative Information

NCT Number ^ICMJE

NCT00481481

Other Study ID Numbers ^ICMJE

PMR-EC-1209

Has Data Monitoring Committee

Responsible Party

Disclosure Office Europe, Astellas Pharma Europe BV

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Central Contact

Astellas Pharma GmbH

Information Provided By

Astellas Pharma Inc

Verification Date

May 2009

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

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