Special Notice KPMP 20210916.docx

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) seeks Industry Collaborators for the Kidney Precision Medicine Project (KPMP)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) of the Department of Health and Human Services (DHHS) seeks Industry collaborators in NIH-sponsored multi-center clinical and molecular studies in people with Diabetic Kidney Disease, Hypertension-related Chronic Kidney Disease, or Acute Kidney Injury.

BACKGROUND:

In July 2017, the NIDDK’s Division of Kidney, Urologic and Hematologic Diseases initiated the Kidney Precision Medicine Project Consortium. The goal of this consortium is to obtain, under the highest ethical and safety standards, kidney tissue by renal biopsy from patients with Acute Kidney Injury (AKI) and Chronic Kidney Disease (CKD) – in whom such biopsies are not usually obtained in clinical practice. Kidney biopsies from the participants will be subject to state of the art molecular and other analyses, and the Consortium will create a kidney tissue atlas, define disease subgroups, and identify cells, pathways and targets for novel therapies. The Consortium will also collect biosamples (e.g., blood, urine, stool).

Current & future studies – The KPMP has initiated a clinical protocol for the ethical consent of participants with underlying CKD and AKI and the collection of research biopsies. The protocol can be found here: https://drive.google.com/file/d/1pFRcWRXYeswjruoG-EBz49zCA9DJPiwu/view

The KPMP supports an ongoing longitudinal study of AKI and CKD. Over 100 subjects have been recruited for this study. Further information may be found for NCT04334707 at www.clinicaltrials.gov. Opportunities for collaboration include, but are not limited to: novel diagnostics, genetic factors, proteomics, metabolomics, lipidomics, imaging studies, and determinants of disease pathogenesis, progression and severity.

STUDY GOALS:

The overall aim of the KPMP, supported by the NIDDK, is to develop a patient-centric community resource for the interrogation of molecular pathways which define healthy and diseased kidney with the overarching goal of identifying novel, druggable pathways to improve health outcomes for individuals with AKI and CKD.

The KPMP is interested in establishing collaborations with commercial organizations to conduct research that will accelerate the achievement of these goals. We aim to:

• Deeply phenotype KPMP participants with AKI or CKD using novel diagnostic devices or biomedical imaging technologies, investigating, for example, kidney function, pathologies, physiologic reserve, or metabolism.

• Interrogate biosamples (e.g., tissue blocks, blood, urine, stool), measuring aspects of, for example, the microbiome, (epi)genome, transcriptome, lipidome and proteome.

• Enhance preservation of key analytes or anatomical structures in a kidney biopsy specimen for downstream interrogation using proprietary reagents or devices.

• Streamline workflow by introducing technologies that provide immediate feedback on the size, composition, or quality of kidney biopsy specimens.

• Interrogate kidney biopsy tissue with high spatial and analytical resolution using proprietary reagents, novel bioanalytical tools, or 2- or 3-dimensional microscopic methods.

• Deeply phenotype KPMP participants with AKI or CKD using novel software apps or devices, investigating, for example, diet, environment, physical activity or energy expenditure.

• Improve the safety profile or accuracy of kidney biopsy using, for example, novel biomedical imaging techniques or simulation or training modules.

• Investigate proprietary reagents, or devices for the identification of modifiable AKI and CKD pathways.

• Evaluate nondestructive imaging methods for assessing disease activity.

PROPOSALS:

Commercial organizations interested in pursuing collaborations with NIDDK for KPMP are required to submit an on-line proposal application to the KPMP Ancillary Studies Committee.

The process for submitting proposals, as well as finding more detail regarding the KPMP network, is managed within an on-line system sponsored by the KPMP Ancillary Studies Committee.

All applications, application materials, resources and instructions for consideration of a collaboration can be found at https://www.kpmp.org/collaboration. Information for Ancillary Studies can be found at https://www.kpmp.org/ancillary-studies.

OPEN and On-Going Submissions:

Application proposal submissions for the KPMP network will be rolling, on-going, and without a specified deadline.

The Ancillary Studies Committee will review all submissions as received. NIH reserves the right to amend this notice to include deadlines in the future.

NOTE:

NO FUNDS WILL BE PROVIDED BY NIDDK TO ANY ORGANIZATION SELECTED FOR THIS RESEARCH COLLABORATION OPPORTUNITY.

SUBMISSION AND INQUIRIES:

Proposal Applications to be submitted to:

The KPMP Central Hub Email: info@kpmp.org and

For Scientific Inquiries contact:

Cindy N. Roy, PhD Program Director, Hematology Division of Kidney, Urologic and Hematologic Diseases (KUH) National Institute of Diabetes and Digestive and Kidney Diseases National Institutes of Health 6707 Democracy Blvd Bethesda, MD 20817 Office: 301-594-8805

FAX: 301-480-3510

Email: cindy.roy@nih.gov

For Inquiries Regarding Partnering with NIDDK (Intellectual Property Matters and Collaboration Agreements) contact:

Vladimir Knezevic, MD Senior Advisor for Commercial Evaluation Technology Advancement Office

NIDDK/NIH

Phone: 301-435-5560 vlado.knezevic@niddk.nih.gov

Contracting Office Address:

6100 Executive Boulevard, Room 5Z00 Bethesda, Maryland 20892-7510 (Contracting Office Address)