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 Long-Term Outcomes with Everolimus After Calcineurin Inhibitor Withdrawal: 36M Results of the H2304 and PROTECT Extension Studies.

L. Fischer,1,2 J. Fung,1 H. Metselaar,1 G. Kaiser,1,2 P. Schemmer,2 P. Neuhaus,2 G. Dong,3 P. Lopez,4 P. Bernhardt,4 H. Schlitt.2

1H2304 study group, Hamburg, Germany
2PROTECT study group, Hamburg, Germany
3Novartis Pharmaceuticals Corporation, East Hanover, NJ
4Novartis Pharma AG, Basel, Switzerland.

Meeting: 2016 American Transplant Congress

Abstract number: 144

Keywords: Efficacy, Immunosuppression, Liver transplantation, Renal function

Session Information

Date: Sunday, June 12, 2016

Session Name: Concurrent Session: Liver: Immunosuppression and Rejection

Session Time: 4:30pm-6:00pm

 Presentation Time: 5:30pm-5:42pm

Location: Room 312

Related Abstracts
  • Evaluation of the Major Adverse Cardiac Events Risk with Everolimus-Based Calcineurin Inhibitor Reduction or Withdrawal Regimen in Liver Transplant Recipients: 3-Year Post-Hoc Analysis of the Randomized H2304 Extension Study.
  • Everolimus and Early Calcineurin Inhibitor Withdrawal Is Associated With Superior Renal Function: 5-Year Follow-Up of the Randomized PROTECT Liver Transplantation Study

Background: The H2304 and PROTECT studies demonstrated reduced nephrotoxicity with everolimus (EVR)-based calcineurin inhibitor (CNI; cyclosporine: CsA, tacrolimus: TAC)-free regimens at Month (M) 12. Here, we evaluate the approaches based on 36M results from CNI withdrawal (WD) vs standard (C) CNI regimens from these studies.

Methods: H2304 study recruited patients in CNI-WD (N = 231) arm to receive EVR (C0 3-8 ng/mL; increased to C0 6-10 ng/mL by end of M4) + rTAC (C0 3-5 ng/mL; withdrawn at M4), 1M post-liver transplantation (LTx). Enrollment into CNI-WD arm was prematurely terminated due to higher acute rejection rate during CNI withdrawal; however, patients on study treatment for >4M could continue in the regimen. In PROTECT, patients in CNI-WD (N = 101) arm received EVR + CNI (TAC or CsA) 4-8 weeks post-LTx with EVR C0 target of 5-12 when combined with TAC or 8-12 ng/mL in combination with CsA. After CNI withdrawal EVR C0 was maintained at 5-12 ng/mL.CNI was completely withdrawn when patients were stable with 70% CNI reduction (for at least 2M) latest by M6 post-LTx and all patients received basiliximab induction therapy.

Results: At M36, incidence of tBPAR was higher in CNI-WD arm vs CNI-C in both studies (Figure 1a & 1b). However, there was no increase in graft loss in CNI-WD vs CNI-C arm (H2304: 2.8% vs 4.0%; PROTECT: 2.2% vs 2.1%). In both the studies, renal function (eGFR; MDRD4) improved significantly in CNI-WD vs CNI-C arms and incidence of AEs and SAEs was similar in CNI-WD vs CNI-C arm (Table 1).

Conclusion: Although an increased risk of rejection was seen at the time of CNI withdrawal in H2304 study, complete CNI withdrawal without risk of subsequent efficacy failure, can be achieved with the introduction of induction therapy and stepwise CNI reduction as seen in PROTECT. Despite the differences in rejection rates, CNI-WD arm in both studies showed better renal function preservation vs CNI-C arm.

CITATION INFORMATION: Fischer L, Fung J, Metselaar H, Kaiser G, Schemmer P, Neuhaus P, Dong G, Lopez P, Bernhardt P, Schlitt H. Evaluation of the Long-Term Outcomes with Everolimus After Calcineurin Inhibitor Withdrawal: 36M Results of the H2304 and PROTECT Extension Studies. Am J Transplant. 2016;16 (suppl 3).

  • Tweet
  • Email
  • Print

To cite this abstract in AMA style:

Fischer L, Fung J, Metselaar H, Kaiser G, Schemmer P, Neuhaus P, Dong G, Lopez P, Bernhardt P, Schlitt H. Evaluation of the Long-Term Outcomes with Everolimus After Calcineurin Inhibitor Withdrawal: 36M Results of the H2304 and PROTECT Extension Studies. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/evaluation-of-the-long-term-outcomes-with-everolimus-after-calcineurin-inhibitor-withdrawal-36m-results-of-the-h2304-and-protect-extension-studies/. Accessed March 1, 2021.

« Back to 2016 American Transplant Congress

Most Viewed Abstracts

  • This Week
  • This Month
  • All Time
  • Low GFR after Kidney Donation Is Not Chronic Kidney Disease
  • Live Related Kidney Transplant Experience in Abuja, Nigeria – First Eight Cases Ever.
  • Low GFR after Kidney Donation Is Not Chronic Kidney Disease
  • Live Related Kidney Transplant Experience in Abuja, Nigeria – First Eight Cases Ever.
  • Left-Sided Donor Nephrectomy Predisposes Living Kidney Donors to Latent Adrenal Insufficiency with Symptoms of Fatigue and Inferior Quality of Life.
  • Home
  • Search
  • 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

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

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.