Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes
Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved..
New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant. Critical Path Institute's Transplant Therapeutics Consortium received a qualification opinion for the iBOX Scoring System as a novel secondary efficacy endpoint for kidney transplant clinical trials through European Medicines Agency's qualification of novel methodologies for drug development. This is the first qualified endpoint for any transplant indication and is now available for use in kidney transplant clinical trials. Although the current efficacy failure endpoint has typically shown the noninferiority of therapeutic regimens, the iBOX Scoring System can be used to demonstrate the superiority of a new immunosuppressive therapy compared to the standard of care from 6 months to 24 months posttransplant in pivotal or exploratory drug therapeutic studies.
| Errataetall: |
CommentIn: Am J Transplant. 2023 Oct;23(10):1481-1482. - PMID 37652175 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:23 |
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| Enthalten in: |
American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons - 23(2023), 10 vom: 19. Okt., Seite 1496-1506 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Klein, Amanda [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 04.10.2023 Date Revised 13.10.2023 published: Print-Electronic CommentIn: Am J Transplant. 2023 Oct;23(10):1481-1482. - PMID 37652175 Citation Status MEDLINE |
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| doi: |
10.1016/j.ajt.2023.04.018 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM362316449 |
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| 520 | |a New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant. Critical Path Institute's Transplant Therapeutics Consortium received a qualification opinion for the iBOX Scoring System as a novel secondary efficacy endpoint for kidney transplant clinical trials through European Medicines Agency's qualification of novel methodologies for drug development. This is the first qualified endpoint for any transplant indication and is now available for use in kidney transplant clinical trials. Although the current efficacy failure endpoint has typically shown the noninferiority of therapeutic regimens, the iBOX Scoring System can be used to demonstrate the superiority of a new immunosuppressive therapy compared to the standard of care from 6 months to 24 months posttransplant in pivotal or exploratory drug therapeutic studies | ||
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| 700 | 1 | |a Kosinski, Luke |e verfasserin |4 aut | |
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| 700 | 1 | |a Podichetty, Jagdeep T |e verfasserin |4 aut | |
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