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