Grafting, Kidney, Kidney Transplantation, Renal Transplantation, Transplantation, Kidney, Transplantation, Renal
Conditions
Keywords
Treatment Efficacy, Treatment Effectiveness, Anti-rejection therapy, Immunosuppression, Antirejection, Malononitrilamide
Brief summary
A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients
Interventions
DRUGFK778
Sponsors
Astellas Pharma Europe B.V.
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons). * Patient has been fully informed.
Exclusion criteria
* Patient has an immunological high risk and/or having a previous graft survival shorter than 1 year due to immunological reasons. * Patient has significant liver disease. * Cold ischemia time of the donor kidney \>28 hours. * Patient having uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer. * Patient has previously received or is receiving an organ transplant other than kidney.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of biopsy-proven acute rejection over the first 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year | — |
| 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 | — |
| Routine safety laboratory parameters | — |
Countries
Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed