ATC Abstracts

American Transplant Congress abstracts

  • Home
  • Meetings Archive
    • 2020 American Transplant Congress
    • 2019 American Transplant Congress
    • 2018 American Transplant Congress
    • 2017 American Transplant Congress
    • 2016 American Transplant Congress
    • 2015 American Transplant Congress
    • 2013 American Transplant Congress
  • Keyword Index
  • Resources
    • 2016 Resources
      • 2016 Welcome Letter
      • ATC 2016 Program Planning Committees
      • ASTS Council 2015-2016
      • AST Board of Directors 2015-2016
    • 2015 Resources
      • 2015 Welcome Letter
      • ATC 2015 Program Planning Committees
      • ASTS Council 2014-2015
      • AST Board of Directors 2014-2015
      • 2015 Conference Schedule
  • Advanced Search

Evaluation of the Safety and Tolerability of Clazakizumab® (Anti-IL-6 Monoclonal) as a Desensitization Agent in Highly-HLA Sensitized ESRD Patients (nct03380962)

A. A. Vo, N. Ammerman, E. Huang, A. Peng, R. Najjar, S. Sethi, S. Williamsons, C. Myers, K. Lim, J. Choi, S. C. Jordan

Cedars Sinai Medical Ctr, Los Angeles, CA

Meeting: 2019 American Transplant Congress

Abstract number: 27

Keywords: Highly-sensitized, HLA antibodies, Kidney transplantation, Plasmapheresis

Session Information

Date: Sunday, June 2, 2019

Session Name: Concurrent Session: Kidney Immunosuppression: Desensitization

Session Time: 2:30pm-4:00pm

 Presentation Time: 2:42pm-2:54pm

Location: Ballroom A

Related Abstracts
  • Anti-HLA IgM Antibodies Are Reduced in Highly-HLA Sensitized Patients Transplanted after Imlifidase (IdeS) Treatment
  • Sequential Dosing of Rituximab and IVIg for Desensitization of Highly-HLA Sensitized (HS) Patients Awaiting HLAi Kidney Transplantation

*Purpose: Currently, there is growing interest in development of novel immune-modulatory drugs likely to improve allo-antibody reduction in transplantation. Clazakizumab (Vitaeris Inc.) is a humanized monoclonal antibody aimed at the cytokine IL-6. Here we undertook a single center Phase I/II open label pilot study to assess safety and efficacy of clazakizumab as a desensitization agent in highly-HLA sensitized (HS) patients awaiting HLAi renal transplantation.

*Methods: From March 2018 to present, 9 HS patients (cPRA >50%) received plasma exchange (PLEX) x5 sessions followed by IVIg 2gm/kg (maximum 140 grams) X 1. One week post-IVIg, the patients received clazakizumab, 25mg SC Q4W X 6 doses with monitoring of HLA antibody levels and other immune parameters. Study end point was transplantation by day 270 post-Rx. If transplanted, patients received 6 additional doses of clazakizumab, 25mg SC Q4W starting 5-7 days post-transplant, with a 6-month protocol biopsy. The primary end point of this open label study was reduction of HLA antibodies from baseline. All transplanted HS patients received antibody induction with alemtuzumab and were maintained on standard immunosuppression with tacrolimus, cellcept, and tapering prednisone.

*Results: Nine patients have been enrolled to date. Sum MFI of HLA specificities over time for individual study patient is shown {Fig 1}. Specificities ranged from 100,000-1,100,000 MFI pre-PLEX and was reduced to 0-950,000 MFI by dose #5 of clazakizumab. Previously, we noted that anti-HLA antibodies tended to rebound by approximately 1-3 months after completion of PLEX/IVIg. Here, with monthly clazakizumab, MFI values remained stable and did not rebound when compared to pre-PLEX. Four transplants were performed to date. Three of 4 patients had FCMX+ and DSA+ at time of transplant. One graft was lost to a technical issue at transplant. The patient was continued on clazakizumab post-nephrectomy with no HLA antibody rebound and with subsequent successful transplant 7 months later. SAEs included wound dehiscence requiring wound re-closure (1), hematuria and UTI (1), and bacteremia prior to receiving 1st dose of study drug (1), all felt unrelated to clazakizumab.

*Conclusions: Although preliminary, clazakizumab appears promising as a potential desensitization agent when used with PLEX + IVIg. Reducing the risk of antibody rebound post-PLEX + IVIg may aid in achieving successful HLAi transplantation for these patients.

 border=

  • Tweet
  • Email
  • Print

To cite this abstract in AMA style:

Vo AA, Ammerman N, Huang E, Peng A, Najjar R, Sethi S, Williamsons S, Myers C, Lim K, Choi J, Jordan SC. Evaluation of the Safety and Tolerability of Clazakizumab® (Anti-IL-6 Monoclonal) as a Desensitization Agent in Highly-HLA Sensitized ESRD Patients (nct03380962) [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/evaluation-of-the-safety-and-tolerability-of-clazakizumab-anti-il-6-monoclonal-as-a-desensitization-agent-in-highly-hla-sensitized-esrd-patients-nct03380962/. Accessed April 18, 2021.

« Back to 2019 American Transplant Congress

Most Viewed Abstracts

  • This Week
  • This Month
  • All Time
  • Subtherapeutic Low Tacrolimus Trough Levels (≤3.5 Ng /ml) Are A Risk Factor For Acute Rejection And Creatinine Doubling.
  • Low GFR after Kidney Donation Is Not Chronic Kidney Disease
  • Is There a Difference Between DCD and DBD Kidney Transplantation with Similar KDPI?
  • Penis Transplantation: First U.S. Experience.
  • Kidney Dialysis after Heart Transplantation: The Short and Long Term Outcomes
  • Subtherapeutic Low Tacrolimus Trough Levels (≤3.5 Ng /ml) Are A Risk Factor For Acute Rejection And Creatinine Doubling.
  • Low GFR after Kidney Donation Is Not Chronic Kidney Disease
  • Is There a Difference Between DCD and DBD Kidney Transplantation with Similar KDPI?
  • Penis Transplantation: First U.S. Experience.
  • Live Related Kidney Transplant Experience in Abuja, Nigeria – First Eight Cases Ever.
  • Penis Transplantation: First U.S. Experience.
  • Is There a Difference Between DCD and DBD Kidney Transplantation with Similar KDPI?
  • Low GFR after Kidney Donation Is Not Chronic Kidney Disease
  • Evidence of a Clinically Significant Drug-Drug Interaction between Cannabidiol and Tacrolimus: A Case Report
  • Kidney Dialysis after Heart Transplantation: The Short and Long Term Outcomes

Visit Our Partner Sites

American Transplant Congress (ATC)

Visit the official site for the American Transplant Congress »

American Journal of Transplantation

The official publication for the American Society of Transplantation (AST) and the American Society of Transplant Surgeons (ASTS) »

American Society of Transplantation (AST)

An organization of more than 3000 professionals dedicated to advancing the field of transplantation. »

American Society of Transplant Surgeons (ASTS)

The society represents approximately 1,800 professionals dedicated to excellence in transplantation surgery. »

Copyright © 2013-2021 by American Society of Transplantation and the American Society of Transplant Surgeons. All rights reserved.

Privacy Policy | Terms of Use

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.
This site uses cookies: Find out more.