@article{e5f70c0a016243b8b419d2db0128f51a,
title = "Qualifying a Novel Clinical Trial Endpoint (iBOX) Predictive of Long-Term Kidney Transplant Outcomes",
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.",
keywords = "iBox, kidney transplant, organ transplant, transplant clinical trial, transplant outcomes",
author = "Amanda Klein and Alexandre Loupy and Mark Stegall and Ilkka Helanter{\"a} and Luke Kosinski and Eric Frey and Olivier Aubert and Gillian Divard and Kenneth Newell and Meier-Kriesche, {Herwig Ulf} and Roslyn Mannon and Thomas Dumortier and Varun Aggarwal and Podichetty, {Jagdeep T.} and Inish O{\textquoteright}Doherty and Gaber, {Ahmed Osama} and Fitzsimmons, {William E.}",
note = "Funding Information: Critical Path Institute is supported by the FDA of the US Department of Health and Human Services (HHS) and is 54.2% funded by the FDA/HHS, totaling $13,239,950, and 45.8% funded by nongovernment sources, totaling $11,196,634. TTC is supported by funds from the transplant community, including the biopharmaceutical and diagnostic industries, professional societies, and regulatory agencies, combined with support from academic institutions, ensuring that people living with a transplant are at the core of all we do. Funding Information: AK, LK, EF, and VA are employed by C-Path. AL holds shares in Cibiltech. IH holds research funds from MSD and Hansa Biopharma, receives consultancy honoraria from Hansa Biopharma, MSD, Novartis, and Takeda, is an associate editor for American Journal of Transplantation, and is a Coordinating Committee member of TTC. H-UM-K is employed by Veloxis Pharmaceuticals. KN serves as a scientific advisory board member for Angion, Care Dx, CSL Behring, Hansa Biopharma, Immucor, Novartis, Sangamo Therapeutics, Sanofi, Takeda, Talaris, and Viela Bio. RM is employed by University of Nebraska Medical Center; serves as a consultant for Chinook Therapeutics and Olaris Inc; holds research funding from Transplant Genomics, Inc and Verici DX; has received honoraria from CSL Behring; holds patents or royalties with Eurofins; has an advisory or leadership role with Vitaerris VKTX01 IMAGINE Trial and Verici Dx; and is Chair, ASN Policy and Advocacy Committee; Immediate Past-Chair, Women in Transplantation; Member, ASN Grants Committee; Chair, SRTR Review Committee; Member, DSMB, NIDDK/NIH; and Deputy Editor, American Journal of Transplantation. AG receives research funding from Hansa Biopharma, Veloxis Pharmaceuticals, Novartis, and Medeor Therapeutics. WF serves on the Board of Directors of CTI Clinical Trial Services; is Adjunct Professor at University of Illinois at Chicago; is founder of Tutela Pharmaceuticals; and serves as a consultant to Azoth Immune Medicines, Tract Therapeutics, and Veloxis Pharmaceuticals. Publisher Copyright: Copyright {\textcopyright} 2023 Klein, Loupy, Stegall, Helanter{\"a}, Kosinski, Frey, Aubert, Divard, Newell, Meier-Kriesche, Mannon, Dumortier, Aggarwal, Podichetty, O{\textquoteright}Doherty, Gaber and Fitzsimmons.",
year = "2023",
doi = "10.3389/ti.2023.11951",
language = "English (US)",
volume = "36",
journal = "Transplant International",
issn = "0934-0874",
publisher = "Frontiers Media SA",
}