Opportunity Information: Apply for RFA DK 08 015
Apply for RFA DK 08 015
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Chronic Kidney Disease Biomarker Discovery and Validation Consortium (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847 Diabetes, Digestive, and Kidney Diseases Extramural Research.
- This funding opportunity was created on Jan 14, 2009 and posted on Jan 14, 2009.
- Applicants must submit their applications by Apr 1, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $2,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Tribally Controlled Colleges and Universities (TCCUs) .
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Opportunity Summary:
The Chronic Kidney Disease Biomarker Discovery and Validation Consortium (U01) opportunity (RFA-DK-08-015) is a National Institutes of Health program led by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to fund research teams that can discover new biomarkers and/or rigorously validate biomarkers that have already been proposed for clearly defined human chronic kidney diseases (CKD). The central idea is to build a multi-center consortium rather than isolated, single-site projects, with the expectation that coordinated efforts across institutions can speed up biomarker development, improve reproducibility, and generate evidence strong enough to move biomarkers closer to clinical use. This aligns with NIDDK priorities around preventing CKD progression, improving management, and supporting regression where possible by enabling earlier detection, better risk stratification, and more sensitive tracking of disease activity and treatment response than traditional measures alone.
The public health rationale for the program is the growing and costly burden of CKD in the United States and other industrialized countries. The announcement highlights a documented rise in CKD prevalence for stages 1 through 4 in the U.S., increasing from about 10.0% in the 1988-1994 period to about 13.1% in 1999-2004. It also points to the significant clinical and financial impact of end-stage kidney disease (stage 5 CKD, kidney failure), which typically requires dialysis or transplantation and is among the most resource-intensive chronic conditions to treat. By supporting biomarker discovery and validation, the FOA is aimed at improving the tools available to detect disease earlier, predict which patients are most likely to worsen, and measure whether interventions are working before irreversible damage occurs.
This funding is offered as a cooperative agreement (U01), which typically means the NIH expects substantial scientific and programmatic involvement during the award period compared with a standard research project grant. In practical terms, applicants should anticipate collaborative governance, shared consortium activities, and coordinated approaches to study design, sample handling, data standards, and analysis plans so that results from different sites can be compared and combined. The activity category is health (CFDA 93.847, Diabetes, Digestive, and Kidney Diseases Extramural Research), and the opportunity was posted January 14, 2009, with an application due date of April 1, 2009 (now archived as of May 2, 2009).
The total estimated funding level listed for the initiative is $2,500,000, with an award ceiling of $500,000. No cost sharing or matching is required. A broad range of applicant organizations were eligible, including public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (including those with and without 501(c)(3) status, other than institutions of higher education), for-profit organizations (including small businesses and other for-profits), and tribal entities. The eligibility list also explicitly includes a variety of minority-serving institutions and specialized categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs), along with Native American tribal governments (federally recognized and other than federally recognized) and Native American tribal organizations.
Overall, the opportunity is best understood as an NIH-funded, consortium-based effort focused on moving CKD biomarkers along the pipeline from discovery to credible validation in human populations with well-defined chronic kidney diseases. The emphasis on multi-center collaboration suggests that proposals were expected to be designed for scalability and comparability across sites, which is critical in biomarker research where differences in patient populations, specimen collection, assay platforms, and analytic methods can otherwise make promising findings hard to replicate and hard to translate into real-world clinical decision-making.
Frequently Asked Questions
What is the Chronic Kidney Disease Biomarker Discovery and Validation Consortium (U01) opportunity?
This opportunity (RFA-DK-08-015) is an NIH program led by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to fund research teams focused on chronic kidney disease (CKD) biomarker discovery and/or rigorous biomarker validation in humans with clearly defined CKD.
What is the main goal of this funding opportunity?
The main goal is to accelerate the development of CKD biomarkers by supporting coordinated, multi-center work that can discover new biomarkers and/or generate strong validation evidence for biomarkers that have already been proposed, helping move them closer to clinical use.
What kinds of projects are supported: biomarker discovery, validation, or both?
Both. The program is designed to support teams that can discover new biomarkers and/or rigorously validate biomarkers that have already been proposed, as long as the work is focused on clearly defined human chronic kidney diseases.
Why does the program emphasize a multi-center consortium instead of single-site studies?
The central idea is that coordinated efforts across institutions can speed up biomarker development, improve reproducibility, and allow results to be compared and combined across sites. This is especially important in biomarker research where differences in patient populations, specimen collection, assays, and analytic methods can make findings difficult to replicate or translate into clinical decision-making.
What public health problem is this program intended to address?
The program is motivated by the growing and costly burden of CKD in the United States and other industrialized countries, including increasing prevalence and the major clinical and financial impact of end-stage kidney disease (kidney failure), which often requires dialysis or transplantation.
What CKD prevalence trend is cited as part of the rationale?
The announcement highlights a documented rise in U.S. CKD prevalence for stages 1 through 4, increasing from about 10.0% in 1988-1994 to about 13.1% in 1999-2004.
How could CKD biomarkers supported by this program improve patient care?
The program is aimed at enabling earlier detection of CKD, better risk stratification to predict which patients are most likely to worsen, and more sensitive tracking of disease activity and treatment response than traditional measures alone, potentially before irreversible damage occurs.
What NIH funding mechanism is used, and what does it imply for awardees?
The funding mechanism is a cooperative agreement (U01). This typically means NIH expects substantial scientific and programmatic involvement during the award period, with collaborative governance and shared consortium activities. Applicants should anticipate coordinated approaches to study design, sample handling, data standards, and analysis plans.
Which NIH institute leads this program?
The program is led by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health (NIH).
What is the activity category and CFDA number listed for this opportunity?
The activity category is health, and the CFDA listing provided is 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
How much total funding is estimated for the initiative?
The total estimated funding level listed for the initiative is $2,500,000.
What is the award ceiling for individual awards?
The listed award ceiling is $500,000.
Is cost sharing or matching required?
No. The opportunity states that no cost sharing or matching is required.
Who is eligible to apply?
A broad range of organizations are listed as eligible, including public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (with and without 501(c)(3) status, other than institutions of higher education), for-profit organizations (including small businesses), and tribal entities.
Are minority-serving institutions and tribal organizations included in the eligibility list?
Yes. The eligibility list explicitly includes multiple categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Native American tribal governments (federally recognized and other than federally recognized), and Native American tribal organizations.
What diseases or populations are the biomarkers expected to relate to?
The focus is on biomarkers for clearly defined human chronic kidney diseases (CKD), with the intent to generate evidence relevant to human populations rather than isolated, single-site findings.
What types of coordination are applicants expected to plan for in a consortium setting?
The opportunity indicates that teams should anticipate coordinated approaches across sites, including alignment on study design, specimen/sample handling, data standards, and analysis plans, so results from different institutions can be compared and combined.
When was this opportunity posted, and when were applications due?
The opportunity was posted on January 14, 2009, and the application due date was April 1, 2009.
Is this opportunity still open?
No. It is described as archived as of May 2, 2009.
How does this program align with NIDDK priorities?
The program aligns with NIDDK priorities around preventing CKD progression, improving disease management, and supporting regression where possible, by enabling earlier detection, improved risk prediction, and better measurement of disease activity and response to treatment.
Why is validation highlighted as a key part of this program?
The program emphasizes generating rigorous, credible evidence so biomarkers can move closer to clinical use. Multi-center validation helps address reproducibility challenges caused by differences in populations, specimen handling, assay platforms, and analytic methods.
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