Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects (CONCERTO)
|ClinicalTrials.gov Identifier: NCT00481481|
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : July 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Transplantation||Drug: tacrolimus||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||346 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2007|
|Primary Completion Date :||April 2009|
|Study Completion Date :||April 2009|
- Change in creatinine clearance, calculated according to Cockcroft and Gault formula. [ Time Frame: Week 24 ]
- 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 ]
- Rating of subjects according to reason for conversion: Changes in mean lipid levels (total cholesterol) [ Time Frame: Week 24 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481481
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|Study Director:||Central Contact||Astellas Pharma GmbH|