Qualifying a Novel Clinical Trial Endpoint (iBOX) Predictive of Long-Term Kidney Transplant Outcomes

Amanda Klein; Alexandre Loupy; Mark Stegall; Ilkka Helanterä; Luke Kosinski; Eric Frey; Olivier Aubert; Gillian Divard; Kenneth Newell; Herwig Ulf Meier-Kriesche; Roslyn Mannon; Thomas Dumortier; Varun Aggarwal; Jagdeep T. Podichetty; Inish O’Doherty; Ahmed Osama Gaber; William E. Fitzsimmons

doi:10.3389/ti.2023.11951

Qualifying a Novel Clinical Trial Endpoint (iBOX) Predictive of Long-Term Kidney Transplant Outcomes

Amanda Klein, Alexandre Loupy, Mark Stegall, Ilkka Helanterä, Luke Kosinski, Eric Frey, Olivier Aubert, Gillian Divard, Kenneth Newell, Herwig Ulf Meier-Kriesche, Roslyn Mannon, Thomas Dumortier, Varun Aggarwal, Jagdeep T. Podichetty, Inish O’Doherty, Ahmed Osama Gaber, William E. Fitzsimmons

Transplant Surgery

Research output: Contribution to journal › Article › peer-review

Abstract

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.

Original language	English (US)
Article number	11951
Journal	Transplant International
Volume	36
DOIs	https://doi.org/10.3389/ti.2023.11951
State	Published - 2023

Keywords

iBox
kidney transplant
organ transplant
transplant clinical trial
transplant outcomes

ASJC Scopus subject areas

Transplantation

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10.3389/ti.2023.11951

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Klein, A., Loupy, A., Stegall, M., Helanterä, I., Kosinski, L., Frey, E., Aubert, O., Divard, G., Newell, K., Meier-Kriesche, H. U., Mannon, R., Dumortier, T., Aggarwal, V., Podichetty, J. T., O’Doherty, I., Gaber, A. O., & Fitzsimmons, W. E. (2023). Qualifying a Novel Clinical Trial Endpoint (iBOX) Predictive of Long-Term Kidney Transplant Outcomes. Transplant International, 36, Article 11951. https://doi.org/10.3389/ti.2023.11951

Klein, A, Loupy, A, Stegall, M, Helanterä, I, Kosinski, L, Frey, E, Aubert, O, Divard, G, Newell, K, Meier-Kriesche, HU, Mannon, R, Dumortier, T, Aggarwal, V, Podichetty, JT, O’Doherty, I, Gaber, AO & Fitzsimmons, WE 2023, 'Qualifying a Novel Clinical Trial Endpoint (iBOX) Predictive of Long-Term Kidney Transplant Outcomes', Transplant International, vol. 36, 11951. https://doi.org/10.3389/ti.2023.11951

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abstract = "New immunosuppressive therapies that improve long-term graft survival are needed in kidney transplant. Critical Path Institute{\textquoteright}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{\textquoteright}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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AU - O’Doherty, Inish

AU - Gaber, Ahmed Osama

AU - Fitzsimmons, William E.

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Qualifying a Novel Clinical Trial Endpoint (iBOX) Predictive of Long-Term Kidney Transplant Outcomes

Abstract

Keywords

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