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; the TRANSFORM group

doi:10.1016/j.kint.2023.03.007

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, the TRANSFORM group

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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.

Original language	English
Pages (from-to)	36-45
Number of pages	10
Journal	Kidney International
Volume	104
Issue number	1
DOIs	https://doi.org/10.1016/j.kint.2023.03.007
Publication status	Published - Jul 2023

Keywords

CKD
drug development
ISN
kidney

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10.1016/j.kint.2023.03.007Licence: CC BY-NC-ND

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Nangaku, M., Kitching, A. R., Boor, P., Fornoni, A., Floege, J., Coates, P. T., Himmelfarb, J., Lennon, R., Anders, H. J., Humphreys, B. D., Caskey, F. J., Fogo, A. B., & the TRANSFORM group (2023). International Society of Nephrology first consensus guidance for preclinical animal studies in translational nephrology. Kidney International, 104(1), 36-45. https://doi.org/10.1016/j.kint.2023.03.007

@article{034a8b055aea49adb5d1a412f0577cab,

title = "International Society of Nephrology first consensus guidance for preclinical animal studies in translational nephrology",

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, drug development, ISN, kidney",

author = "Masaomi Nangaku and Kitching, {A. Richard} and Peter Boor and Alessia Fornoni and J{\"u}rgen Floege and Coates, {P. Toby} and Jonathan Himmelfarb and Rachel Lennon and Anders, {Hans Joachim} and Humphreys, {Benjamin D.} and Caskey, {Fergus J.} and Fogo, {Agnes B.} and Andrea Angeletti and Bedard, {Patricia W.} and Ariela Benigni and Granqvist, {Anna Bj{\"o}rnson} and Chabova, {Vera Certikova} and Christos Chatziantoniou and Jennifer Cross and Sandrine Damster and Donner, {Jo Ann} and Frank Eitner and Stanislas Faguer and Antonio Fontanella and Yuri Fujimoto and Joseph Gaut and Leslie Gewin and Hansen, {Pernille B.L.} and He, {John Cijiang} and Jeremy Hughes and Reiko Inagi and Celia Jenkinson and Vivekanand Jha and Mikio Kato and Darren Kelly and Jeffrey Kopp and Ron Korstanje and Romaldas Ma{\v c}iulaitis and Mark, {Patrick B.} and Marti, {Hans Peter} and McAdoo, {Stephen P.} and Miner, {Jeffrey H.} and Alberto Ortiz and Parikh, {Samir M.} and Ambra Pozzi and Paola Romagnani and Pierre Ronco and Rovin, {Brad H.} and Julio Saez-Rodriguez and Saleem, {Moin A.} and Sayer, {John A.} and Stuart Shankland and Shaw, {Andrey S.} and Yusuke Suzuki and Tomoko Takano and Sydney Tang and Rene Tolba and John Viel and Yoshihisa Yamada and Motoko Yanagita and Takashi Yokoo and Nobuya Yoshida and Darren Yuen and Roy Zent and Aihua Zhang and {the TRANSFORM group}",

note = "Publisher Copyright: {\textcopyright} 2023 International Society of Nephrology",

year = "2023",

month = jul,

doi = "10.1016/j.kint.2023.03.007",

language = "English",

volume = "104",

pages = "36--45",

journal = "Kidney International",

issn = "0085-2538",

publisher = "Elsevier",

number = "1",

}

Nangaku, M, Kitching, AR, Boor, P, Fornoni, A, Floege, J, Coates, PT, Himmelfarb, J, Lennon, R, Anders, HJ, Humphreys, BD, Caskey, FJ, Fogo, AB & the TRANSFORM group 2023, 'International Society of Nephrology first consensus guidance for preclinical animal studies in translational nephrology', Kidney International, vol. 104, no. 1, pp. 36-45. https://doi.org/10.1016/j.kint.2023.03.007

TY - JOUR

T1 - International Society of Nephrology first consensus guidance for preclinical animal studies in translational nephrology

AU - Nangaku, Masaomi

AU - Kitching, A. Richard

AU - Boor, Peter

AU - Fornoni, Alessia

AU - Floege, Jürgen

AU - Coates, P. Toby

AU - Himmelfarb, Jonathan

AU - Lennon, Rachel

AU - Anders, Hans Joachim

AU - Humphreys, Benjamin D.

AU - Caskey, Fergus J.

AU - Fogo, Agnes B.

AU - Angeletti, Andrea

AU - Bedard, Patricia W.

AU - Benigni, Ariela

AU - Granqvist, Anna Björnson

AU - Chabova, Vera Certikova

AU - Chatziantoniou, Christos

AU - Cross, Jennifer

AU - Damster, Sandrine

AU - Donner, Jo Ann

AU - Eitner, Frank

AU - Faguer, Stanislas

AU - Fontanella, Antonio

AU - Fujimoto, Yuri

AU - Gaut, Joseph

AU - Gewin, Leslie

AU - Hansen, Pernille B.L.

AU - He, John Cijiang

AU - Hughes, Jeremy

AU - Inagi, Reiko

AU - Jenkinson, Celia

AU - Jha, Vivekanand

AU - Kato, Mikio

AU - Kelly, Darren

AU - Kopp, Jeffrey

AU - Korstanje, Ron

AU - Mačiulaitis, Romaldas

AU - Mark, Patrick B.

AU - Marti, Hans Peter

AU - McAdoo, Stephen P.

AU - Miner, Jeffrey H.

AU - Ortiz, Alberto

AU - Parikh, Samir M.

AU - Pozzi, Ambra

AU - Romagnani, Paola

AU - Ronco, Pierre

AU - Rovin, Brad H.

AU - Saez-Rodriguez, Julio

AU - Saleem, Moin A.

AU - Sayer, John A.

AU - Shankland, Stuart

AU - Shaw, Andrey S.

AU - Suzuki, Yusuke

AU - Takano, Tomoko

AU - Tang, Sydney

AU - Tolba, Rene

AU - Viel, John

AU - Yamada, Yoshihisa

AU - Yanagita, Motoko

AU - Yokoo, Takashi

AU - Yoshida, Nobuya

AU - Yuen, Darren

AU - Zent, Roy

AU - Zhang, Aihua

AU - the TRANSFORM group

PY - 2023/7

Y1 - 2023/7

N2 - 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.

AB - 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.

KW - CKD

KW - drug development

KW - ISN

KW - kidney

UR - http://www.scopus.com/inward/record.url?scp=85151290790&partnerID=8YFLogxK

U2 - 10.1016/j.kint.2023.03.007

DO - 10.1016/j.kint.2023.03.007

M3 - Article

AN - SCOPUS:85151290790

SN - 0085-2538

VL - 104

SP - 36

EP - 45

JO - Kidney International

JF - Kidney International

IS - 1

ER -

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

Abstract

Keywords

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Corrigendum to “International Society of Nephrology first consensus guidance for preclinical animal studies in translational nephrology.” Kidney International, 2023;104:36–45 (Kidney International (2023) 104(1) (36–45), (S0085253823001746), (10.1016/j.kint.2023.03.007))

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