Kidney International Publishes ISN First Consensus Guidance for Pre-Clinical Animal Studies in Translational Nephrology
Kidney International has published the “International Society of Nephrology First Consensus Guidance for Pre-clinical Animal Studies in Translational Nephrology.” The paper was developed from the First Consensus Meeting on Guidance for Optimal Pre-Clinical Animal Studies in Translational Nephrology (TRANSFORM) hosted by the ISN in Brussels, Belgium, in October 2022.
Pre-clinical tests in animal models are key steps in early drug development. Drugs that work well in animals often fail to work in human trials, so it is critical to address the issue of translatability. Research guidelines to report animal studies exist; however, further expert guidance could provide additional value, particularly in planning animal studies.
Recognizing this, the ISN held a consensus meeting to connect experts in the global kidney care community to guide the optimal management of translational animal studies for developing new drugs to treat kidney disease: “TRANSFORM; TRAnslational Nephrology Science FOR new Medications.”
This is the first such guidance. The recommendations are designed to accelerate the development of new drugs to effectively treat kidney diseases and improve the prognosis and quality of life of people living with kidney diseases.
Consensus recommendations were developed for the following: (1) selection of the pre-clinical disease model; (2) pharmacokinetic studies; (3) interventions in late-stage pre-clinical studies; (4) choice of animals; (5) number of animals to be studied; (6) evaluation of kidney disease models; (7) controls and analysis in pre-clinical models of kidney disease; (8) organoids and organs-on-a-chip; and (9) reporting experiments and their results.
The ISN Research Working Group planned and launched the meeting, made possible with unrestricted educational grants from (in alphabetical order): Astra Zeneca, Aurinia Pharma, Daiichi Sankyo, Kyowa Kirin, Otsuka Pharmaceutical Co. Ltd., and Travere Therapeutics.
This initiative is part of ISN’s desire to grow the research capacity of the global nephrology community by identifying and coordinating strategic directions and activities aligned with ISN’s mission, vision, and values. Consider further supporting our work by becoming an ISN member.