A prospective, double-blind, randomized study of high-versus low-dose OKT3 induction immunosuppression in cadaveric renal transplantation

Douglas Norman, Jess A. Kimball, William M. Bennett, Fuad Shihab, Thomas D. Batiuk, Mary M. Meyer, John Barry

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

We undertook a prospective, double-blind study of high-(5-mg) versus low-(2-mg) dose OKT3 for induction immunosuppression (12 days) in cadaveric renal allograft transplantation. Maintenance immunosuppression was identical in both groups and consisted of azathioprine and prednisone initially, with cyclosporine beginning on the 5th postoperative day. Twenty-six patients were randomized. The groups were similar in terms of age, kidney ischemia time, peak PRA, and latest PRA. There were more diabetics and women in the high-dose group. Patient survival at 12 months was 100% in both groups. Graft survival at 12 months was 92% and 100% in the high- and low-dose groups, respectively. Infections were mostly minior and equal in frequency in the two groups. All patients receiving high- or low-dose OKT3 had manifestations of the cytokine release syndrome; these were delayed in onset in the low-dose group. Eleven patients (85%) in each group produced anti-OKT3 andtibodies. Lymphocyte depletion after 1 day was major (>98%) and identical in both groups. CD3 antigens were removed more slowly in the low-dose group but eventually at equal rates in both groups. Cost was significantly lower in the low-dose group. We conclude that while both doses of OKT3 were effective and safe for induction immunosuppression, it may be prudent to use a lower dose of OKT3 for induction immunosuppression because of its potential to reduce cytokine-mediated effects and to avoid the complications of overimmunosuppression and because of the lower costs associated with it.

Original languageEnglish (US)
Pages (from-to)356-361
Number of pages6
JournalTransplant International
Volume7
Issue number5
DOIs
StatePublished - Aug 1994

Fingerprint

Muromonab-CD3
Double-Blind Method
Kidney Transplantation
Immunosuppression
Lymphocyte Depletion
CD3 Antigens
Cytokines
Costs and Cost Analysis
Azathioprine
Graft Survival
Prednisone
Cyclosporine
Allografts
Ischemia
Maintenance
Kidney
Survival
Infection

Keywords

  • Immunosuppression, OKT3, dose
  • Kidney transplantation, OKT3, dose
  • OKT3, dose, renal transplantation

ASJC Scopus subject areas

  • Transplantation

Cite this

A prospective, double-blind, randomized study of high-versus low-dose OKT3 induction immunosuppression in cadaveric renal transplantation. / Norman, Douglas; Kimball, Jess A.; Bennett, William M.; Shihab, Fuad; Batiuk, Thomas D.; Meyer, Mary M.; Barry, John.

In: Transplant International, Vol. 7, No. 5, 08.1994, p. 356-361.

Research output: Contribution to journalArticle

Norman, Douglas ; Kimball, Jess A. ; Bennett, William M. ; Shihab, Fuad ; Batiuk, Thomas D. ; Meyer, Mary M. ; Barry, John. / A prospective, double-blind, randomized study of high-versus low-dose OKT3 induction immunosuppression in cadaveric renal transplantation. In: Transplant International. 1994 ; Vol. 7, No. 5. pp. 356-361.
@article{dd0e71c5b21a4d799a6c6299cdccfc20,
title = "A prospective, double-blind, randomized study of high-versus low-dose OKT3 induction immunosuppression in cadaveric renal transplantation",
abstract = "We undertook a prospective, double-blind study of high-(5-mg) versus low-(2-mg) dose OKT3 for induction immunosuppression (12 days) in cadaveric renal allograft transplantation. Maintenance immunosuppression was identical in both groups and consisted of azathioprine and prednisone initially, with cyclosporine beginning on the 5th postoperative day. Twenty-six patients were randomized. The groups were similar in terms of age, kidney ischemia time, peak PRA, and latest PRA. There were more diabetics and women in the high-dose group. Patient survival at 12 months was 100{\%} in both groups. Graft survival at 12 months was 92{\%} and 100{\%} in the high- and low-dose groups, respectively. Infections were mostly minior and equal in frequency in the two groups. All patients receiving high- or low-dose OKT3 had manifestations of the cytokine release syndrome; these were delayed in onset in the low-dose group. Eleven patients (85{\%}) in each group produced anti-OKT3 andtibodies. Lymphocyte depletion after 1 day was major (>98{\%}) and identical in both groups. CD3 antigens were removed more slowly in the low-dose group but eventually at equal rates in both groups. Cost was significantly lower in the low-dose group. We conclude that while both doses of OKT3 were effective and safe for induction immunosuppression, it may be prudent to use a lower dose of OKT3 for induction immunosuppression because of its potential to reduce cytokine-mediated effects and to avoid the complications of overimmunosuppression and because of the lower costs associated with it.",
keywords = "Immunosuppression, OKT3, dose, Kidney transplantation, OKT3, dose, OKT3, dose, renal transplantation",
author = "Douglas Norman and Kimball, {Jess A.} and Bennett, {William M.} and Fuad Shihab and Batiuk, {Thomas D.} and Meyer, {Mary M.} and John Barry",
year = "1994",
month = "8",
doi = "10.1007/BF00336712",
language = "English (US)",
volume = "7",
pages = "356--361",
journal = "Transplant International",
issn = "0934-0874",
publisher = "Wiley-Blackwell",
number = "5",

}

TY - JOUR

T1 - A prospective, double-blind, randomized study of high-versus low-dose OKT3 induction immunosuppression in cadaveric renal transplantation

AU - Norman, Douglas

AU - Kimball, Jess A.

AU - Bennett, William M.

AU - Shihab, Fuad

AU - Batiuk, Thomas D.

AU - Meyer, Mary M.

AU - Barry, John

PY - 1994/8

Y1 - 1994/8

N2 - We undertook a prospective, double-blind study of high-(5-mg) versus low-(2-mg) dose OKT3 for induction immunosuppression (12 days) in cadaveric renal allograft transplantation. Maintenance immunosuppression was identical in both groups and consisted of azathioprine and prednisone initially, with cyclosporine beginning on the 5th postoperative day. Twenty-six patients were randomized. The groups were similar in terms of age, kidney ischemia time, peak PRA, and latest PRA. There were more diabetics and women in the high-dose group. Patient survival at 12 months was 100% in both groups. Graft survival at 12 months was 92% and 100% in the high- and low-dose groups, respectively. Infections were mostly minior and equal in frequency in the two groups. All patients receiving high- or low-dose OKT3 had manifestations of the cytokine release syndrome; these were delayed in onset in the low-dose group. Eleven patients (85%) in each group produced anti-OKT3 andtibodies. Lymphocyte depletion after 1 day was major (>98%) and identical in both groups. CD3 antigens were removed more slowly in the low-dose group but eventually at equal rates in both groups. Cost was significantly lower in the low-dose group. We conclude that while both doses of OKT3 were effective and safe for induction immunosuppression, it may be prudent to use a lower dose of OKT3 for induction immunosuppression because of its potential to reduce cytokine-mediated effects and to avoid the complications of overimmunosuppression and because of the lower costs associated with it.

AB - We undertook a prospective, double-blind study of high-(5-mg) versus low-(2-mg) dose OKT3 for induction immunosuppression (12 days) in cadaveric renal allograft transplantation. Maintenance immunosuppression was identical in both groups and consisted of azathioprine and prednisone initially, with cyclosporine beginning on the 5th postoperative day. Twenty-six patients were randomized. The groups were similar in terms of age, kidney ischemia time, peak PRA, and latest PRA. There were more diabetics and women in the high-dose group. Patient survival at 12 months was 100% in both groups. Graft survival at 12 months was 92% and 100% in the high- and low-dose groups, respectively. Infections were mostly minior and equal in frequency in the two groups. All patients receiving high- or low-dose OKT3 had manifestations of the cytokine release syndrome; these were delayed in onset in the low-dose group. Eleven patients (85%) in each group produced anti-OKT3 andtibodies. Lymphocyte depletion after 1 day was major (>98%) and identical in both groups. CD3 antigens were removed more slowly in the low-dose group but eventually at equal rates in both groups. Cost was significantly lower in the low-dose group. We conclude that while both doses of OKT3 were effective and safe for induction immunosuppression, it may be prudent to use a lower dose of OKT3 for induction immunosuppression because of its potential to reduce cytokine-mediated effects and to avoid the complications of overimmunosuppression and because of the lower costs associated with it.

KW - Immunosuppression, OKT3, dose

KW - Kidney transplantation, OKT3, dose

KW - OKT3, dose, renal transplantation

UR - http://www.scopus.com/inward/record.url?scp=0028141970&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0028141970&partnerID=8YFLogxK

U2 - 10.1007/BF00336712

DO - 10.1007/BF00336712

M3 - Article

C2 - 7993573

AN - SCOPUS:0028141970

VL - 7

SP - 356

EP - 361

JO - Transplant International

JF - Transplant International

SN - 0934-0874

IS - 5

ER -