A Phase 2 interventional study of FK778 in Kidney Transplantation, Renal Transplantation and Transplantation, Renal, sponsored by Astellas Pharma Inc. Completed at 37 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-04-17.
Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Treatment
A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients
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:
Incidence of biopsy-proven acute rejection over the first 24 weeks.
Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year
Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year
Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year
Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year
Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year
Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year
Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.
Safety first 24 weeks: Patient survival
Graft survival
Incidence of adverse events
Routine safety laboratory parameters
Haemoglobin values at weeks two to six
Leukocytes at weeks two to six
Thrombocytes at weeks two to six
Bilirubin at weeks two to six
Incidence of CMV viraemia
Incidence of Diarrhoea, Gastroenteritis and Gastritis
Safety after 1 year:Incidence of adverse events
Patient and graft survival
This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Inc