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Daclizumab induction/tacrolimus sparing: a randomized prospective trial in renal transplantation
Author(s) -
Light Jimmy A,
Sasaki Truman M,
Ghasemian Reza,
Barhyte Diana Y,
Fowlkes Deneen L
Publication year - 2002
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1034/j.1399-0012.16.s7.4.x
Subject(s) - tacrolimus , daclizumab , medicine , transplantation , prednisone , urology , adverse effect , gastroenterology , pharmacology , surgery
Tacrolimus inhibits lymphocyte responses by blocking calcium‐dependent signalling pathways important in IL‐2 generation. Daclizumab, a humanized monoclonal antibody, binds with high affinity to the Tac subunit of the IL‐2 receptor complex. We reasoned therefore that the absence of IL‐2R should permit lower doses of tacrolimus and thereby less toxicity. Twenty‐eight patients were randomized and followed for 6 months: Group 1, high dose (HD) tacrolimus (trough 12–17 ng/mL; n = 13); Group 2, low dose (LD) tacrolimus (trough 5–10 ng/mL; n = 15). All patients received daclizumab induction (2 mg/kg) on days 0 and 14, mycophenolate mofetil (2 g/d except for one patient who received 1 g) and rapid prednisone taper. Serious infections were minimal in both groups. Hospitalizations, for various reasons, were HD ( n = 12) and LD ( n = 6). All patients and grafts survived for the 6‐month study period. There was one rejection episode in a non‐compliant patient at 101 d. LD tacrolimus appears equally effective as HD tacrolimus in preventing rejection episodes and may be associated with fewer adverse events.