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A Randomized, Doubleblind, Placebo-Controlled, Study of Single-Dose Rituximab as Induction in Renal Transplantation

Tyden, Gunnar; Genberg, Helena; Tollemar, Jan; Ekberg, Henrik LU ; Persson, Nils H.; Tufveson, Gunnar; Wadstrom, Jonas; Gabel, Markus and Mjornstedt, Lars (2009) In Transplantation 87(9). p.1325-1329
Abstract
We performed a prospective, double blind, randomized, placebo-controlled multicenter study on the efficacy and safety of rituximab as induction therapy, together with tacrolimus, mycophenolate mofetil, and steroids. The primary endpoint was defined as acute rejection, graft loss, or death during the first 6 months. Secondary endpoints were creatinine clearance, incidence of infections, and incidence of rituximab-related adverse event. Results. We enrolled 140 patients (44 living donor and 96 deceased donor), and of those, 68 rituximab and 68 placebo patients fulfilled the study. In all the patients receiving rituximab, there was a complete depiction of CD 19/CD20 cells, whereas there was no change in the number of CD19/CD20 cells in the... (More)
We performed a prospective, double blind, randomized, placebo-controlled multicenter study on the efficacy and safety of rituximab as induction therapy, together with tacrolimus, mycophenolate mofetil, and steroids. The primary endpoint was defined as acute rejection, graft loss, or death during the first 6 months. Secondary endpoints were creatinine clearance, incidence of infections, and incidence of rituximab-related adverse event. Results. We enrolled 140 patients (44 living donor and 96 deceased donor), and of those, 68 rituximab and 68 placebo patients fulfilled the study. In all the patients receiving rituximab, there was a complete depiction of CD 19/CD20 cells, whereas there was no change in the number of CD19/CD20 cells in the placebo group. There were 10 treatment failures in the rituximab group versus 14 in the placebo group (P=0.348). There were eight rejection episodes in the rituximab group versus 12 in the placebo group (P=0.317) Creatinine clearance was 66 +/- 22 mL/min in the study group and 67 +/- 23 mL/min in the placebo group. There was no difference in the number of bacterial infections, cytomegalovirus infections, and BK virus infections or fungal infections. Conclusion. We performed a placebo-controlled study of rituximab induction in renal transplantation. There was a tendency toward fewer and milder rejections during the first 6 months in the rituximab group. Although induction with one dose of rituximab induced a complete depletion B cells, there was no increase in the incidence of infectious complications or leukopenia and it seems safe, therefore, to conduct further studies on the use of rituximab in transplantation. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
B-cells, Transplantation, Rituximab, Renal
in
Transplantation
volume
87
issue
9
pages
1325 - 1329
publisher
Lippincott Williams & Wilkins
external identifiers
  • wos:000266048100011
  • scopus:67649607453
ISSN
1534-6080
DOI
10.1097/TP.0b013e3181a235fd
language
English
LU publication?
yes
id
3a45ca1c-96d4-417c-b13b-8a84823feded (old id 1425775)
date added to LUP
2009-06-30 14:01:37
date last changed
2017-05-28 04:05:22
@article{3a45ca1c-96d4-417c-b13b-8a84823feded,
  abstract     = {We performed a prospective, double blind, randomized, placebo-controlled multicenter study on the efficacy and safety of rituximab as induction therapy, together with tacrolimus, mycophenolate mofetil, and steroids. The primary endpoint was defined as acute rejection, graft loss, or death during the first 6 months. Secondary endpoints were creatinine clearance, incidence of infections, and incidence of rituximab-related adverse event. Results. We enrolled 140 patients (44 living donor and 96 deceased donor), and of those, 68 rituximab and 68 placebo patients fulfilled the study. In all the patients receiving rituximab, there was a complete depiction of CD 19/CD20 cells, whereas there was no change in the number of CD19/CD20 cells in the placebo group. There were 10 treatment failures in the rituximab group versus 14 in the placebo group (P=0.348). There were eight rejection episodes in the rituximab group versus 12 in the placebo group (P=0.317) Creatinine clearance was 66 +/- 22 mL/min in the study group and 67 +/- 23 mL/min in the placebo group. There was no difference in the number of bacterial infections, cytomegalovirus infections, and BK virus infections or fungal infections. Conclusion. We performed a placebo-controlled study of rituximab induction in renal transplantation. There was a tendency toward fewer and milder rejections during the first 6 months in the rituximab group. Although induction with one dose of rituximab induced a complete depletion B cells, there was no increase in the incidence of infectious complications or leukopenia and it seems safe, therefore, to conduct further studies on the use of rituximab in transplantation.},
  author       = {Tyden, Gunnar and Genberg, Helena and Tollemar, Jan and Ekberg, Henrik and Persson, Nils H. and Tufveson, Gunnar and Wadstrom, Jonas and Gabel, Markus and Mjornstedt, Lars},
  issn         = {1534-6080},
  keyword      = {B-cells,Transplantation,Rituximab,Renal},
  language     = {eng},
  number       = {9},
  pages        = {1325--1329},
  publisher    = {Lippincott Williams & Wilkins},
  series       = {Transplantation},
  title        = {A Randomized, Doubleblind, Placebo-Controlled, Study of Single-Dose Rituximab as Induction in Renal Transplantation},
  url          = {http://dx.doi.org/10.1097/TP.0b013e3181a235fd},
  volume       = {87},
  year         = {2009},
}