Renal Transplantation
Conditions
Keywords
Renal Transplantation, Prograf
Brief summary
A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept
Interventions
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: * Patient is between post kidney transplant day 3-7 and no requirement for dialysis Exclusion: * Patient is receiving kidney from HLA identical,living donor * Patient is a multi-organ transplant recipient * Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of death, graft loss, or severe acute rejection | 6 months, 12 months, yearly up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of patient and graf survival | 6 months, 12 months, yearly up to 5 years |
| Incidence and severity of acute rejection | 6 months, 12 months, yearly up to 5 years |
| Need for antilymphocyte treatment | 6 months, 12 months, yearly up to 5 years |
| Graft function | 6 month, 12 months, yearly up to 5 years |
| Framingham Coronary Heart Disease Risk Factors | 6 months, 12 months, yearly up to 5 years |
Countries
United States
Outcome results
None listed