Clinical trial NCT00481481: Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects
Official title: A Multicenter, Single-arm, Open, Conversion Study From a Cyclosporine (CyA) Based Immunosuppressive Regimen to a Tacrolimus Modified Release, FK506E (MR4), Based Immunosuppressive Regimen in Kidney Transplant Subjects (CONCERTO: Converting Cyclosporine to FK506E (MR4) in Renal Transplantation)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transplantation
Keywords: Tacrolimus, Kidney Transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-06-01
Enrollment: 346
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in creatinine clearance, calculated according to Cockcroft and Gault formula.
timeFrame: Week 24
Secondary outcomes:
measure: Change in creatinine clearance, calculated according to Cockcroft and Gault formula, between Baseline (Day 1) and week 24 (End of Study) overall
timeFrame: Week 24
measure: Rating of subjects according to reason for conversion: Changes in mean lipid levels (total cholesterol)
timeFrame: Week 24
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Linz
country: Austria
city: Vienna
country: Austria
city: Brussels
country: Belgium
city: Edegem
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Roeselare
country: Belgium
city: Olomouc
country: Czech Republic
city: Prague
country: Czech Republic
city: Aarhus
country: Denmark
city: Helsinki
country: Finland
city: Bordeaux
country: France
city: Brest
country: France
city: Paris
country: France
city: Pierre-Benite
country: France
city: Strasbourg
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Vandoeuvre
country: France
city: Berlin
country: Germany
city: Cologne
country: Germany
city: Essen
country: Germany
city: Halle
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Leipzig
country: Germany
city: Lubeck
country: Germany
city: Munich
country: Germany
city: Tubingen
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Bologna
country: Italy
city: Cagliari
country: Italy
city: Firenze
country: Italy
city: Genova
country: Italy
city: L'Aquila
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Treviso
country: Italy
city: Udine
country: Italy
city: Gdansk
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Warsaw
country: Poland
city: Alicante
country: Spain
city: Badajoz
country: Spain
city: Barakaldo
country: Spain
city: Madrid
country: Spain
city: Oviedo
country: Spain
city: Palma de Mallorca
country: Spain
city: Salamanca
country: Spain
city: Lund
country: Sweden
city: Zurich
country: Switzerland
Study officials:
affiliation: Astellas Pharma GmbH
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: Rostaing L, Sanchez-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.