A randomized clinical trial of induction therapy with OKT3 in kidney transplantation

Douglas Norman, Lawrence Kahana, Frank P. Stuart, James R. Thistlethwaite, Charles F. Shield, Anthony Monaco, Jennifer Dehlinger, Shu Chen Wu, Allan Van Horn, Thomas P. Haverty

Research output: Contribution to journalArticle

133 Citations (Scopus)

Abstract

A randomized, prospective multicenter trial was conducted to compare the safety and efficacy of OKT3 as an induction therapy with that of conventional immunosuppressive therapy administered to cadaveric renal allograft recipients. Two hundred fifteen patients were treated either with OKT3 plus azathioprine and steroids for 14 days with the delayed addition of cyclosporine on day 11, or with conventional immunosuppression (steroids, azathioprine, and cyclosporine). OKT3 patients had significantly fewer rejection episodes (51% vs. 66%, P=0.032), a longer time to initial rejection (46 days vs. 8 days, P=0.001), and fewer rejection episodes per patient (0.82 vs. 1.14, P=0.014) than conventionally treated patients. Kaplan-Meier estimates of two-year graft and patient survival rates were 84% and 95%, respectively, for the OKT3-treated group, and 75% and 94%, respectively, for the conventionally treated group. Following a subsequent first rejection episode, OKT3 reversed 93% of the rejections in patients receiving OKT3 induction therapy and 94% in patients receiving conventional therapy. Adverse experiences reported during OKT3 induction therapy were similar to those seen when the drug was used for rejection. Following initial exposure, 40.3% of the patients tested were positive for anti-OKT3 antibody, only 6.7% of which were of high titer (1:1000). In the presence of low titer (1:100 or less) antibody, OKT3 was successful in reversing rejection in five of six retreated patients tested. In conclusion, treatment with OKT3 (in combination with azathioprine, steroids, and the delayed addition of cyclosporine) is an effective approach for renal allograft maintenance.

Original languageEnglish (US)
Pages (from-to)44-50
Number of pages7
JournalTransplantation
Volume55
Issue number1
StatePublished - 1993

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Muromonab-CD3
Kidney Transplantation
Randomized Controlled Trials
Azathioprine
Cyclosporine
Therapeutics
Steroids
Allografts
Kidney
Kaplan-Meier Estimate
Graft Survival
Immunosuppressive Agents
Immunosuppression
Multicenter Studies
Anti-Idiotypic Antibodies
Survival Rate
Maintenance
Safety

ASJC Scopus subject areas

  • Transplantation
  • Immunology

Cite this

Norman, D., Kahana, L., Stuart, F. P., Thistlethwaite, J. R., Shield, C. F., Monaco, A., ... Haverty, T. P. (1993). A randomized clinical trial of induction therapy with OKT3 in kidney transplantation. Transplantation, 55(1), 44-50.

A randomized clinical trial of induction therapy with OKT3 in kidney transplantation. / Norman, Douglas; Kahana, Lawrence; Stuart, Frank P.; Thistlethwaite, James R.; Shield, Charles F.; Monaco, Anthony; Dehlinger, Jennifer; Wu, Shu Chen; Van Horn, Allan; Haverty, Thomas P.

In: Transplantation, Vol. 55, No. 1, 1993, p. 44-50.

Research output: Contribution to journalArticle

Norman, D, Kahana, L, Stuart, FP, Thistlethwaite, JR, Shield, CF, Monaco, A, Dehlinger, J, Wu, SC, Van Horn, A & Haverty, TP 1993, 'A randomized clinical trial of induction therapy with OKT3 in kidney transplantation', Transplantation, vol. 55, no. 1, pp. 44-50.
Norman D, Kahana L, Stuart FP, Thistlethwaite JR, Shield CF, Monaco A et al. A randomized clinical trial of induction therapy with OKT3 in kidney transplantation. Transplantation. 1993;55(1):44-50.
Norman, Douglas ; Kahana, Lawrence ; Stuart, Frank P. ; Thistlethwaite, James R. ; Shield, Charles F. ; Monaco, Anthony ; Dehlinger, Jennifer ; Wu, Shu Chen ; Van Horn, Allan ; Haverty, Thomas P. / A randomized clinical trial of induction therapy with OKT3 in kidney transplantation. In: Transplantation. 1993 ; Vol. 55, No. 1. pp. 44-50.
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abstract = "A randomized, prospective multicenter trial was conducted to compare the safety and efficacy of OKT3 as an induction therapy with that of conventional immunosuppressive therapy administered to cadaveric renal allograft recipients. Two hundred fifteen patients were treated either with OKT3 plus azathioprine and steroids for 14 days with the delayed addition of cyclosporine on day 11, or with conventional immunosuppression (steroids, azathioprine, and cyclosporine). OKT3 patients had significantly fewer rejection episodes (51{\%} vs. 66{\%}, P=0.032), a longer time to initial rejection (46 days vs. 8 days, P=0.001), and fewer rejection episodes per patient (0.82 vs. 1.14, P=0.014) than conventionally treated patients. Kaplan-Meier estimates of two-year graft and patient survival rates were 84{\%} and 95{\%}, respectively, for the OKT3-treated group, and 75{\%} and 94{\%}, respectively, for the conventionally treated group. Following a subsequent first rejection episode, OKT3 reversed 93{\%} of the rejections in patients receiving OKT3 induction therapy and 94{\%} in patients receiving conventional therapy. Adverse experiences reported during OKT3 induction therapy were similar to those seen when the drug was used for rejection. Following initial exposure, 40.3{\%} of the patients tested were positive for anti-OKT3 antibody, only 6.7{\%} of which were of high titer (1:1000). In the presence of low titer (1:100 or less) antibody, OKT3 was successful in reversing rejection in five of six retreated patients tested. In conclusion, treatment with OKT3 (in combination with azathioprine, steroids, and the delayed addition of cyclosporine) is an effective approach for renal allograft maintenance.",
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