Key Dates

Related Announcements

• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed).  See NOFO PA-23-230.
• July 12, 2023 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed).  See NOFO PA-23-232. 

Issued by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Center for Advancing Translational Sciences (NCATS)

Purpose

This NOSI aims to support the development of innovative approaches to renal replacement therapy and address critical accompanying challenges such as vascular access and fluid management during dialysis.

Background
Chronic Kidney Disease (CKD) and Acute Kidney Injury (AKI) are interconnected syndromes which pose a substantial public health burden. Even with the best available medical therapies, the progressive loss of kidney function can lead to the need for dialysis or kidney transplantation. Hemodialysis and peritoneal dialysis are life-sustaining treatments for kidney failure, but they have substantial limitations and have not significantly improved in decades. Whereas living donor kidney transplantation is preferred, the selection process is complex and lengthy, not all patients are candidates, and organs are in short supply. Unlike dialysis, kidney transplantation cannot be offered emergently. Alternative therapies and technological advances to enhance existing therapies are needed.
Objectives
It is anticipated that the funded applications will propose to develop and test in appropriate models and/or research participants novel technologies related to renal replacement therapy. The applications must be directly related to the mission of the NIDDK, NIBIB, or NCATS. Example areas include, but are not limited to:

• Bioengineered, functional tissue or bioreactors that restore or replace kidney functions, including those that address understudied kidney compartments such as the interstitium
• Regenerative medicine approaches, including bio-printed or organoid-derived kidney tissue, stem cell therapies, or gene therapies to stimulate productive kidney repair/regeneration pathways or in vivo connectivity of bioengineered tissue
• Novel technologies that enable precision dialysis, such as real-time and personalized delivery of renal replacement therapy that leads to significantly improved outcomes, including reduced complications resulting from dialysis treatment (e.g., post dialysis fatigue, hypotension, fluid shift, cramping, nausea)
• Innovative combinations of technologies that distribute electrolyte homeostasis, toxin removal, and volume regulation across different technologies (e.g., a gastrointestinal sorbent and a complementary device, or mechanical and biologic approaches), or closed loop technologies that respond to feedback from integrated sensors.
• Biosensors that collect real-time patient data (e.g., volume status) or novel data that are relevant to improving patient care during renal replacement therapy
• Approaches that integrate real-time physiologic and/or patient-reported measures to significantly improve the patient experience for people with kidney failure (i.e., patient-centered outcomes)
• Wearable, portable, or implantable dialysis systems that improve patient outcomes, accessibility, or patient experience (as measured via robust patient-reported outcome, PRO)
• Novel vascular access or technologies that improve survival, placement, maturation, cannulation, or self-care outcomes, or reduce complications over current standard of care 
• Novel filters or chemistries (e.g., sorbents) that will enable new forms of renal replacement therapies
• Dialysis machines, technologies, or bioengineered membranes that improve patient safety outcomes in renal replacement therapy
• Tools that expand access, self-care, and feasibility of wearable, portable, or home renal replacement modalities 
• Tools to improve assessment or preservation of kidneys for transplant and reduce the organ discard rate and improve functional outcomes
• Re-engineering of existing dialysis technologies for new therapeutic indications

Applications are encouraged from researchers and innovators engaged in major initiatives such as the (Re)Building a Kidney Consortium and the Kidney Innovation Accelerator (KidneyX). Applicants are encouraged to consult the Kidney Health Initiative (KHI) Technology Roadmap For Innovative Alternatives To Renal Replacement Therapy: https://khi.asn-online.org/pages/?ID=8

Applicants who are also participating in KidneyX should be aware of sections of the NIH Grants Policy Statement (GPS) that may apply when a NIH grantee wins a Federal prize competition. Specifically, under Section 8.3.2 of the NIH GPS, the treatment of Program Income in the Notice of Award is usually “Additional Costs.” Program income is gross income--earned by a recipient, a consortium participant, or a contractor under a grant--that was directly generated by the grant-supported activity or earned as a result of the award. If Program Income is generated under this grant award, instructions must be followed for Reporting Program Income, which can be found in Section 8.3.2.1 of the NIH GPS: https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.3.2_program_income.htm

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is interested in supporting applications in all areas described in this NOSI, provided they fall within the mission of the NIDDK. Applicants are strongly encouraged to discuss potential applications with NIDDK's SBIR/STTR Scientific/Research Contacts.

National Center for Advancing Translational Sciences (NCATS)

The National Center for Advancing Translational Sciences (NCATS) mission is to support innovative platform technologies that reduce, remove or bypass costly and time-consuming bottlenecks in the translational science process, to speed the development and delivery of new drugs, diagnostics, medical devices and behavioral interventions to patients across various diseases. Under this funding announcement, NCATS is interested in supporting applications in all areas described in this NOSI that meets the NCATS mission.  Applicants are strongly encouraged to contact Scientific/Research staff about anticipated activities prior to submission.

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in supporting applications under this funding announcement that meet its mission and research priorities. Applicants are strongly encouraged to discuss potential applications with the Scientific/Research Contacts.

Application and Submission Information

This notice applies to due dates on or after January 5, 2024 and subsequent receipt dates through April 7, 2025. 

Submit applications for this initiative using one of the following notice of funding opportunity (NOFO) or any reissues of these announcements through the expiration date of this notice.

• PA-23-230 - PHS 2023-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
• PA-23-232 - PHS 2023-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed) 

All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-DK-23-015” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed notice of funding opportunity.