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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
131
Transplantation Center, Samsung Medical Center
Seoul, South Korea
Graft survival
Time frame: 5 years
Patient survival
Time frame: 5 years
cumulative incidence of acute rejection
Time frame: 5 years
estimated glomerular filtration rate
Time frame: 5 year
new-onset diabetes mellitus
Time frame: 5 year
Hypertension
Time frame: 5 year
hyperlipidemia
Time frame: 5 year
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