Kidney Transplantation
Conditions
Keywords
Malononitrilamide, immunosuppression, treatment efficacy, treatment outcome
Brief summary
A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients
Interventions
DRUGFK778
Sponsors
Astellas Pharma US, Inc.
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living donor kidney. * Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.
Exclusion criteria
* Patient has received or is receiving an organ transplant other than kidney * Patient has received a kidney transplant from a cadaveric donor \>= 60 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| time to first biopsy confirmed acute rejection | — |
| clinically treated acute rejection episodes | — |
| 6 month patient and graft survival rates | — |
| renal function (SrCl and CrCl) | — |
| quantitation of CMV and polyomavirus viral load | — |
| treatment failure (up to 6 months) | — |
Countries
United States
Outcome results
None listed