Randomized trial of single-dose versus divided-dose rabbit anti-thymocyte globulin induction in renal transplantation: an interim report

R. Brian Stevens, David F. Mercer, Wendy J. Grant, Alison G. Freifeld, James T. Lane, Gerald C. Groggel, Theodore H. Rigley, Kathleen J. Nielsen, Megan E. Henning, Jill Y. Skorupa, Anna J. Skorupa, Kecia A. Christensen, John P. Sandoz, Anna M. Kellogg, Alan N. Langnas, Lucile E. Wrenshall

Research output: Contribution to journalArticle

45 Scopus citations

Abstract

Background. The optimal dosing protocol for rabbit anti-thymocyte globulin (rATG) induction in renal transplantation has not been determined, but evidence exists that rATG infusion before renal allograft reperfusion improves early graft function. Infusing a large rATG dose over a short interval has not previously been evaluated for its effect on renal function and allograft nephropathy in a prospective, randomized comparison against conventional rATG induction. Methods. Between April 20, 2004 and December 26, 2007 we enrolled renal transplant patients into a prospective, randomized, nonblinded trial of two rATG dosing protocols (single dose, 6 mg/kg vs. divided doses, 1.5 mg/kg every other day-4; target enrollment=160) followed after 6 months by calcineurin-inhibitor withdrawal. Primary endpoints are renal function by calculated glomerular filtration rate (GFR) and chronic allograft nephropathy at protocol biopsy. Wenow present the early GFR data of all 160 patients and safety and efficacy data of the first 142 patients with 6 months follow up and before calcineurin inhibitor withdrawal (average follow up=23.3=11.6 months). Results. There were no differences between groups in rATG-related adverse events, patient and graft survival, acute rejection, or chronic allograft nephropathy rate at 6 months. Calculated <GFR (POD 1-4) was significantly better in the single-dose group (P=0.02), with a trend toward improved renal function from months 2 to 6 in recipients of deceased donor kidneys (P=0.08). Conclusions. This study demonstrates that administering 6 mg/kg of rATG over 24 hr is safe and is associated with improved early renal function compared with administering rATG in alternate-day doses.

Original languageEnglish (US)
Pages (from-to)1391-1399
Number of pages9
JournalTransplantation
Volume85
Issue number10
DOIs
StatePublished - May 27 2008

Keywords

  • Rabbit Anti-thymocyte globulin
  • Renal Transplantation
  • Renal allograft function

ASJC Scopus subject areas

  • Transplantation

Fingerprint Dive into the research topics of 'Randomized trial of single-dose versus divided-dose rabbit anti-thymocyte globulin induction in renal transplantation: an interim report'. Together they form a unique fingerprint.

  • Cite this

    Stevens, R. B., Mercer, D. F., Grant, W. J., Freifeld, A. G., Lane, J. T., Groggel, G. C., Rigley, T. H., Nielsen, K. J., Henning, M. E., Skorupa, J. Y., Skorupa, A. J., Christensen, K. A., Sandoz, J. P., Kellogg, A. M., Langnas, A. N., & Wrenshall, L. E. (2008). Randomized trial of single-dose versus divided-dose rabbit anti-thymocyte globulin induction in renal transplantation: an interim report. Transplantation, 85(10), 1391-1399. https://doi.org/10.1097/TP.0b013e3181722fad