Kidney Transplantation, Living Donors
Conditions
Brief summary
The use of steroids after kidney transplantation has been challenged because of variable adverse effects which may increase the patient morbidity and mortality. The aim of this study was to compare the safety and efficacy of immunosuppressive regimens consisting of cyclosporine (CsA) and mycophenolate mofetil (MMF) or tacrolimus (TAC) and MMF after steroid withdrawal 6 months after kidney transplantation in low-risk patients.
Detailed description
131 patients were randomized to CsA (n = 63) or TAC (n = 68). Of 118 patients who did not have a biopsy-proven rejection episode and who had a serum creatinine level \< 2.0 mg/dL 6 months after transplantation, 55 were of the CsA group and 63 were of the TAC group. We assessed patient and graft survival, acute rejection episodes, and adverse events 5 years after transplantation.
Interventions
DRUGtacrolimus
DRUGcyclosporine
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* older than 15 years * first living donor kidney transplantation
Exclusion criteria
* congestive heart failure (ejection fraction \< 35%) * chronic liver disease * underlying diabetes mellitus * evidence of systemic infection at screening time * history of malignant disease * multiple organ transplantation * positive serologic evidence of human immunodeficiency virus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft survival | 5 years |
| Patient survival | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| new-onset diabetes mellitus | 5 year |
| cumulative incidence of acute rejection | 5 years |
| hyperlipidemia | 5 year |
| Hypertension | 5 year |
| estimated glomerular filtration rate | 5 year |
Countries
South Korea
Outcome results
None listed