This kidney safety project will impact public health by generating the data needed to advance, among the scientific community, clinicians and regulators the acceptance of the new biomarkers that are appropriate for monitoring kidney safety in the clinic and from reaching alignment on how these biomarkers should be used to improve clinical diagnoses of drug-induced acute kidney injury (AKI) during drug development and during patient therapy with presently marketed and well known nephrotoxic drugs.

This project is a good fit for The Biomarkers Consortium since it addresses a broad spectrum of disease and therapeutic areas, and could affect a large number of potentially effective investigational compounds whose development is halted each year due to renal toxicity issues.  If successful, the project would qualify new biomarkers to improve clinical diagnoses of acute kidney injury during drug development, providing an earlier, more precise and more effective basis for go/no-go decisions in early clinical development.  It will enable continued development of compounds of potential value to patients that might otherwise be abandoned,  provide better, more sensitive mechanisms for evaluating the safety risks to patients in clinical trials, and improve clinical diagnoses of acute kidney injury during patient therapy with presently marketed and well known nephrotoxic drugs.

While the project builds upon the substantial investment and expertise of another consortium, the PSTC, in pre-clinical biomarker qualification, it also clearly requires the specific clinical expertise and broader scale and resources of The Biomarkers Consortium in order to achieve the level of consensus and standardization required for clinical qualification of these biomarkers. The project also leverages an active, ongoing collaborative project with PSTC, which is funding a complementary baseline variation study of these biomarkers in healthy patients. Both projects will be storing their data in the same database and samples in the same biorepository, so that upon project completion both the data and samples will be open for access by the entire scientific community, thereby generating a public research resource. The project will provide valuable input to the FDA’s biomarker qualification process and a model for potential future development and qualification of important drug safety markers in other areas, such as hepatotoxicity and drug induced skeletal muscle injury.

Get involved. Partner with us.

To learn more about partnership opportunities with the Kidney Safety Biomarker Qualification program, contact us:

Paris Moore, Partnership Development Officer, Biomarkers
Phone: 301.443.2103
E-mail: pmoore [at] fnih [dot] org