Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes.

Graft Rejection / etiology Immunosuppression Therapy Immunosuppressive Agents / therapeutic use Kidney Transplantation / adverse effects Clinical Trials as Topic
clinical trials data sharing drug development iBOX kidney transplantation public-private-partnership qualification

Journal

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
ISSN: 1600-6143
Titre abrégé: Am J Transplant
Pays: United States
ID NLM: 100968638

Informations de publication

Date de publication:
10 2023
Historique:
received: 30 12 2022
revised: 30 03 2023
accepted: 12 04 2023
medline: 4 10 2023
pubmed: 22 9 2023
entrez: 21 9 2023
Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.1016/j.ajt.2023.04.018 PMID: 37735044
pubmed: 37735044
pii: S1600-6135(23)00416-1
doi: 10.1016/j.ajt.2023.04.018
pii:
doi:

Substances chimiques

Immunosuppressive Agents 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, P.H.S.

Langues

eng

Sous-ensembles de citation

IM

Pagination

1496-1506

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.

Auteurs

Amanda Klein (A)

Critical Path Institute, Tucson, Arizona, USA. Electronic address: aklein@c-path.org.

Alexandre Loupy (A)

Université de Paris, Cité, Institut national de la santé et de la recherche médicale, U970, PARCC, Paris Translational Research Centre for Organ Transplantation, Paris, France.

Mark Stegall (M)

Department of Surgery, Mayo Clinic, Rochester, Minnesota, USA.

Ilkka Helanterä (I)

Department of Transplantation and Liver Surgery, Helsinki University Hospital, Helsinki, Finland.

Luke Kosinski (L)

Critical Path Institute, Tucson, Arizona, USA.

Eric Frey (E)

Critical Path Institute, Tucson, Arizona, USA.

Olivier Aubert (O)

Université de Paris, Cité, Institut national de la santé et de la recherche médicale, U970, PARCC, Paris Translational Research Centre for Organ Transplantation, Paris, France.

Gillian Divard (G)

Université de Paris, Cité, Institut national de la santé et de la recherche médicale, U970, PARCC, Paris Translational Research Centre for Organ Transplantation, Paris, France.

Kenneth Newell (K)

Division of Transplantation, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.

Herwig-Ulf Meier-Kriesche (HU)

Veloxis Pharmaceuticals, Cary, North Carolina, USA.

Roslyn B Mannon (RB)

Department of Medicine, Division of Nephrology, University of Nebraska Medical Center, Omaha, Nebraska, USA.

Thomas Dumortier (T)

Pharmacometrics, Novartis, Basel, Switzerland.

Varun Aggarwal (V)

Critical Path Institute, Tucson, Arizona, USA.

Jagdeep T Podichetty (JT)

Critical Path Institute, Tucson, Arizona, USA.

Inish O'Doherty (I)

Critical Path Institute, Tucson, Arizona, USA.

Ahmed Osama Gaber (AO)

Department of Surgery, Houston Methodist Hospital, Houston, Texas, USA, and Weill Cornell Medicine, New York, New York, USA.

William E Fitzsimmons (WE)

Critical Path Institute, Tucson, Arizona, USA.

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Classifications MeSH

questionsmedicales.fr › Phénomènes du système immunitaire › Immunologie en transplantation › Réaction de l'hôte contre le greffon › Rejet du greffon › Qualifying a novel clinical trial endpoint...
questionsmedicales.fr › Techniques d'investigation › Techniques immunologiques › Immunosuppression thérapeutique › Qualifying a novel clinical trial endpoint...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Effets physiologiques des médicaments › Facteurs immunologiques › Immunosuppresseurs › Qualifying a novel clinical trial endpoint...
questionsmedicales.fr › Procédures de chirurgie opératoire › Procédures de chirurgie urogénitale › Procédures de chirurgie urologique › Transplantation rénale › Qualifying a novel clinical trial endpoint...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Qualifying a novel clinical trial endpoint...