A Phase 3 interventional study of tacrolimus in Transplantation, sponsored by Astellas Pharma Inc. Completed at 56 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-18.
Sponsored by Astellas Pharma Inc · Phase 3, Interventional, and Treatment
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.
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.
Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: tacrolimus
immunosuppression
Also known as: Advagraf, FK506MR, MR4
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
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc