PMID- 12545341
OWN - NLM
STAT- MEDLINE
DCOM- 20030805
LR  - 20181130
IS  - 0934-0874 (Print)
IS  - 0934-0874 (Linking)
VI  - 16
IP  - 1
DP  - 2003 Jan
TI  - Safety and efficacy of an alternative basiliximab (Simulect) regimen after renal 
      transplantation: administration of a single 40-mg dose on the first postoperative 
      day in patients receiving triple therapy with azathioprine.
PG  - 45-52
AB  - This was a multi-center, open-label, randomized, dose-comparative study on 202 
      renal transplantation patients. We evaluated for the first time an alternative 
      dosing regimen for basiliximab, consisting of a single 40-mg intravenous dose on 
      day 1 post-transplantation plus triple therapy, in comparison with the 
      conventional two-dose regimen (2 h before transplantation and on day 4) plus 
      triple therapy. At 6 months, the incidence of acute rejection was low: 22.5% of 
      patients in the basiliximab 2 x 20-mg group and 20.0% of patients in the 
      basiliximab 1 x 40-mg group experienced an acute rejection episode ( P = 0.628) 
      (biopsy-proven rejection: 19.6% and 17.0%, P = 0.585). There was no statistically 
      significant difference in any of the secondary efficacy parameters. The incidence 
      of graft loss by 12 months was 4.9% and 6.0% in the 2 x 20-mg and 1 x 40-mg 
      group, respectively ( P = 0.73). No differences were observed between the dosage 
      groups with regards to safety assessments (adverse events (AEs), infections, 
      vital signs, laboratory safety evaluations, and physical examinations). The data 
      reveal that basiliximab can be safely and effectively administered as a single 
      40-mg dose on day 1 after renal transplantation as a therapeutic option to the 
      established 2 x 20-mg dosing regimen. This alternative dosing regimen may be of 
      significant convenience under circumstances when a first dose of basiliximab was 
      not given prior to transplantation. Both regimens can conveniently be used during 
      the initial hospitalization of the patient.
FAU - Matl, Ivo
AU  - Matl I
AD  - Clinic of Nephrology, Institute for Clinical and Experimental Medicine, Videnska 
      1958, 14021 Prague 4, Czech Republic. ivmt@medicon.cz
FAU - Bachleda, Petr
AU  - Bachleda P
FAU - Lao, Mieczyslaw
AU  - Lao M
FAU - Michalsky, Rudolf
AU  - Michalsky R
FAU - Navratil, Pavel
AU  - Navratil P
FAU - Treska, Vladislav
AU  - Treska V
FAU - Prestele, Hans
AU  - Prestele H
FAU - Matthisson, Mark
AU  - Matthisson M
FAU - Korn, Alexander
AU  - Korn A
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20021122
PL  - Switzerland
TA  - Transpl Int
JT  - Transplant international : official journal of the European Society for Organ 
      Transplantation
JID - 8908516
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Immunosuppressive Agents)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 83HN0GTJ6D (Cyclosporine)
RN  - 9927MT646M (Basiliximab)
RN  - MRK240IY2L (Azathioprine)
SB  - IM
MH  - Acute Disease
MH  - Adult
MH  - Antibodies, Monoclonal/*administration & dosage/adverse effects
MH  - Azathioprine/*administration & dosage
MH  - Basiliximab
MH  - Cyclosporine/administration & dosage
MH  - Drug Therapy, Combination
MH  - Female
MH  - Graft Rejection/*drug therapy/epidemiology
MH  - Humans
MH  - Immunosuppressive Agents/*administration & dosage
MH  - Incidence
MH  - *Kidney Transplantation
MH  - Male
MH  - Middle Aged
MH  - Postoperative Complications/drug therapy/epidemiology
MH  - *Recombinant Fusion Proteins
EDAT- 2003/01/25 04:00
MHDA- 2003/08/06 05:00
CRDT- 2003/01/25 04:00
PHST- 2001/12/27 00:00 [received]
PHST- 2002/08/05 00:00 [revised]
PHST- 2002/08/23 00:00 [accepted]
PHST- 2003/01/25 04:00 [pubmed]
PHST- 2003/08/06 05:00 [medline]
PHST- 2003/01/25 04:00 [entrez]
AID - 10.1007/s00147-002-0478-x [doi]
PST - ppublish
SO  - Transpl Int. 2003 Jan;16(1):45-52. doi: 10.1007/s00147-002-0478-x. Epub 2002 Nov 
      22.