International Society of Nephrology first consensus guidance for preclinical animal studies in translational nephrology

Masaomi Nangaku; A Richard Kitching; Peter Boor; Alessia Fornoni; Jürgen Floege; P Toby Coates; Jonathan Himmelfarb; Rachel Lennon; Hans-Joachim Anders; Benjamin D Humphreys; Fergus J Caskey; Agnes B Fogo; TRANSFORM group

doi:10.1016/j.kint.2023.03.007

International Society of Nephrology first consensus guidance for preclinical animal studies in translational nephrology

Kidney Int. 2023 Jul;104(1):36-45. doi: 10.1016/j.kint.2023.03.007. Epub 2023 Mar 28.

Authors

Collaborators

TRANSFORM group:
Andrea Angeletti, Patricia W Bedard, Ariela Benigni, Anna Björnson Granqvist, Vera Certikova Chabova, Christos Chatziantoniou, Rolando Claure-Del Granado, Jennifer Cross, Sandrine Damster, Jo-Ann Donner, Frank Eitner, Stanislas Faguer, Antonio Fontanella, Yuri Fujimoto, Joseph Gaut, Leslie Gewin, Pernille B L Hansen, John Cijiang He, Jeremy Hughes, Reiko Inagi, Celia Jenkinson, Vivekanand Jha, Mikio Kato, Darren Kelly, Jeffrey Kopp, Ron Korstanje, Romaldas Mačiulaitis, Patrick B Mark, Hans-Peter Marti, Stephen P McAdoo, Jeffrey H Miner, Alberto Ortiz, Samir M Parikh, Ambra Pozzi, Paola Romagnani, Pierre Ronco, Brad H Rovin, Julio Saez-Rodriguez, Moin A Saleem, John A Sayer, Stuart Shankland, Andrey S Shaw, Maria José Soler, Yusuke Suzuki, Tomoko Takano, Sydney Tang, Rene Tolba, Ifeoma Ulasi, John Viel, Yoshihisa Yamada, Motoko Yanagita, Takashi Yokoo, Nobuya Yoshida, Darren Yuen, Roy Zent, Aihua Zhang

Affiliations

¹ Division of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan. Electronic address: [email protected].
² Centre for Inflammatory Diseases, Monash University Department of Medicine, Clayton, Victoria, Australia; Department of Nephrology, Monash Health, Clayton, Victoria, Australia; Department of Paediatric Nephrology, Monash Health, Clayton, Victoria, Australia.
³ Institute of Pathology, Rheinisch Westfälische Technische Hochschule (RWTH) Aachen University, Aachen, Germany.
⁴ Katz Family Division of Nephrology and Hypertension, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA; Peggy and Harold Katz Family Drug Discovery Center, University of Miami Miller School of Medicine, Miami, Florida, USA.
⁵ Division of Nephrology and Rheumatology, Rheinisch Westfälische Technische Hochschule (RWTH) University Hospital, Aachen, Germany.
⁶ Central and Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, South Australia, Australia; University of Adelaide, Medical Specialties, Adelaide, Australia; South Australian Medical Research Institute, Adelaide, South Australia, Australia.
⁷ Kidney Research Institute, Division of Nephrology, Department of Medicine, University of Washington, Seattle, Washington, USA.
⁸ Wellcome Centre for Cell-Matrix Research, Division of Cell-Matrix Biology and Regenerative Medicine, School of Biological Sciences, Faculty of Biology Medicine and Health, The University of Manchester, Manchester Academic Health Science Centre, Manchester, UK; Department of Paediatric Nephrology, Royal Manchester Children's Hospital, Manchester University Hospitals National Health Service (NHS) Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
⁹ Department of Medicine IV, Hospital of Ludwig Maximilian University of Munich, Munich, Germany.
¹⁰ Division of Nephrology, Department of Medicine, Washington University in St. Louis, St. Louis, Missouri, USA.
¹¹ Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
¹² Department of Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

PMID: 37001557
DOI: 10.1016/j.kint.2023.03.007

Abstract

Preclinical tests in animal models are key steps in early drug development. Consequently, the International Society of Nephrology held a consensus meeting that connected experts in the global kidney community in order to provide guidance on optimal management of translational animal studies for the development of new drugs to treat kidney disease, entitled "TRANSFORM; TRAnslational Nephrology Science FOR new Medications." The meeting covered various themes, including the following: (i) selection of disease model; (ii) pharmacokinetics; (iii) interventions in late preclinical models; (iv) choice of animal; (v) statistical power; (vi) organoids and organ-on-a-chip models; and (vii) reporting of results. This guidance is the first to be provided on the optimal conduct of translational animal studies for the development of new drugs to treat kidney disease. These recommendations are designed to accelerate development of new drugs for efficacious treatment of kidney diseases, and to improve the prognosis and quality of life of patients with a variety of kidney diseases.

Keywords: CKD; ISN; drug development; kidney.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Animals
Consensus
Kidney Diseases* / drug therapy
Nephrology*
Quality of Life
Societies, Medical

Abstract

Publication types

MeSH terms

Grants and funding