Conversion From Cyclosporine to Tacrolimus in Patients at Risk for Chronic Renal Allograft Failure: 60-Month Results of the CRAF Study
05/2008
Journal Article
Authors:
Shihab, F.S.;
Waid, T.H.;
Conti, D.J.;
Yang, H.;
Holman, M.J.;
Mulloy, L.C.;
Henning, A.K.;
Jr, H.;
MR, F.;
Group, C.R.A.F.Study
Secondary:
Transplantation
Volume:
85
Pagination:
1261-1269
URL:
http://www.ncbi.nlm.nih.gov/pubmed?term=18475181
Keywords:
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
Abstract:
{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%
