Conversion From Cyclosporine to Tacrolimus in Patients at Risk for Chronic Renal Allograft Failure: 60-Month Results of the CRAF Study

Publication Type
Journal Article
Year of Publication
Shihab, FS; Waid, TH; Conti, DJ; Yang, H; Holman, MJ; Mulloy, LC; Henning, AK; Holman Jr, J; First MR; CRAF Study Group
Start Page
Date Published
Adult; Cyclosporine; Female; Follow-Up Studies; Immunosuppressive Agents; Kidney Function Tests; kidney transplantation; Male; Middle Aged; numerical data; Patient Selection; Survival Analysis; Tacrolimus; Treatment Failure
{BACKGROUND: This study compared the long-term effects of switching from cyclosporine to tacrolimus on the incidence, progression, and severity of chronic renal allograft failure in patients with elevated serum creatinine levels. METHODS: Patients were assigned randomly (2:1) to switch to tacrolimus or remain on cyclosporine. Tacrolimus was initiated at 1/50th of the cyclosporine dose or 0.15 mg/kg/day, whichever dose was lower, to maintain trough concentrations between 5 and 15 ng/mL. Cyclosporine doses were adjusted to achieve trough concentrations between 100 and 300 ng/mL. RESULTS: At 60 months, the median change from baseline in serum creatinine was -0.2 mg/dL in the tacrolimus group and 0.3 mg/dL in the cyclosporine group (P=0.003). Median change in estimated creatinine clearance was 1.2 mL/min in the tacrolimus group and -4.1 mL/min in the cyclosporine group (P=0.019). The incidence of new-onset diabetes, hyperglycemia, hypertension, lymphoma, and malignancies was generally low and comparable between groups. Fewer patients in the tacrolimus group than in the cyclosporine group developed new cardiac conditions (11% vs. 28%