A prospective randomized trial comparing the efficacy of tacrolimus versuscyclosporine in black recipients of primary cadaveric renal transplants

BACKGROUND: We performed a prospective randomized trial to compare the effi cacy and safety of tacrolimus (FK506) versus cyclosporine (CSA) in black pr imary cadaveric renal transplant (CRT) recipients. METHODS: Between December 1994 and February 1997, 35 black primary CRT reci pients were enrolled in this trial. All patients received 7 days of inducti on therapy with OKT3. Fourteen patients received FK508 and prednisone only. Twenty-one patients received CSA, azathioprine, and prednisone. The two gr oups were comparable in terms of age, gender, plasma renin activity, human leukocyte antigen mismatches, and cause of renal failure. RESULTS: Patient and graft survival were 12 of 14 (86%) for the FK506 group and 20 of 21 (95%) for the CSA group (P = 0.71). Three patients died owing to cardiac events with functioning grafts. Acute rejection was 2 of 14 (14 %) for the FK506 and 8 of 21 (38%) for the CSA group (P = 0.25). Two other patients on CSA were converted to FK506 as rescue for OKT3-resistant reject ion. Mean serum cholesterol at 1 year was 198 +/- 45 mg/dL for the FK506 gr oup and 244 +/- 49 mg/dL for the CSA group (P = 0.03). Mean serum creatinin e at 1 year was 1.39 +/- 0.38 mg/dL for the FK508 group and 1.94 +/- 0.64 m g/dL for the CSA group (P = 0.02). CONCLUSION: Patient and graft survival were similar in both groups at 1 yea r posttransplant. Although statistically not significant, the incidence of acute rejection was lower in the FK506 group. Furthermore, FK506-treated pa tients had significantly lower serum creatinine and cholesterol levels at 1 year posttransplant. Am J Surg. 1999;177:299-302. (C) 1999 by Excerpta Med ica, Inc.