Limited Competition for the Continuation of Cure Glomerulonephropathy (CureGN) Data Coordinating Center (U24 Clinical Trial Not Allowed) | RFA DK 18 504

Opportunity Information: Apply for RFA DK 18 504

This funding opportunity, RFA-DK-18-504, is a limited competition run by the National Institutes of Health (NIH) to continue the Data Coordinating Center (DCC) for the Cure Glomerulonephropathy (CureGN) Network. It uses a U24 cooperative agreement mechanism and is explicitly designated as "Clinical Trial Not Allowed," meaning the work supported is intended to coordinate and sustain an observational research infrastructure rather than launch or run interventional clinical trials. The overall aim is to extend and strengthen CureGN, a large, multicenter observational cohort focused on glomerular diseases, with the long-term goal of improving care and outcomes for patients affected by these conditions.

CureGN was established in 2013 and is organized around four multi-site Participating Clinical Centers (PCCs) plus a central DCC. By the time of this announcement, the network had enrolled nearly 2,200 participants out of a planned 2,400 and had been following them through a structured schedule that includes annual in-person clinic visits complemented by interim telephone contacts. The continuation of the DCC is positioned as essential to keeping the study cohesive and productive as the network moves into its next project period, especially as the cohort matures and the value of longitudinal follow-up grows for understanding disease trajectories.

The DCCs role is described as broad and central, covering study organization, study design and implementation support, overall project management, data management and analysis, and biosample management. In practical terms, this means the DCC is expected to keep the study running smoothly across multiple sites by maintaining common procedures, coordinating operations, ensuring consistent data collection and quality control, managing databases and analytic workflows, and overseeing the handling and tracking of biospecimens. Because CureGN is a complex, multi-site effort with repeated measurements over time, the DCC functions as the hub that makes it possible to combine information across centers into a single, reliable, research-ready resource.

While this FOA focuses on the DCC, it also clarifies what the PCCs will be doing under a separate funding announcement. The clinical centers are expected to continue follow-up of already enrolled participants, with emphasis on clinical assessment of disease activity, the development of novel approaches for "virtual" participation (a nod to remote or technology-enabled follow-up methods), and semi-quantitative assessment of histopathologic lesions. The continuation strategy suggests CureGN is shifting from a primary recruitment phase toward deeper phenotyping, improved follow-up methods, and standardized pathology-related measures, all of which can enhance the scientific value of the cohort.

Scientifically, the continuation is framed around extracting more insight from the carefully curated clinical, biochemical, and pathology-related data generated by the network. The expectation is that paying close attention to disease features unique to glomerulonephropathy, along with outcomes that reflect the full range of patient experience, will help identify new predictors of disease course, clarify underlying disease mechanisms, refine disease subtypes, and point toward novel treatment targets. In that context, the DCC is expected not just to store data, but to actively lead and coordinate the study group toward these next-phase goals by enabling rigorous analyses, harmonized datasets, and efficient collaboration across sites.

Eligibility is limited. The listed eligible applicants include public and state-controlled institutions of higher education, consistent with this being a limited competition for continuation of an established coordinating function. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible. However, the announcement indicates that foreign components, as defined by NIH policy, are allowed, which typically means discrete elements of the project may involve foreign collaboration or activities if they meet NIH requirements, even though the applicant organization itself must be domestic and eligible.

Key administrative details included in the source information are: the agency is NIH; the opportunity is categorized as discretionary; the activity area is health (with CFDA number 93.847); the original closing date was 2018-11-21; and the award ceiling is listed as $1,000,000. Overall, the opportunity is designed to maintain and extend the central coordinating infrastructure that makes CureGN viable as a national multicenter observational cohort, ensuring the network can continue collecting high-quality longitudinal data and biospecimens and translate them into findings that improve understanding and management of glomerular diseases.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Limited Competition for the Continuation of Cure Glomerulonephropathy (CureGN) Data Coordinating Center (U24 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2018-08-30.
• Applicants must submit their applications by 2018-11-21. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
• Eligible applicants include: Public and State controlled institutions of higher education.

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