Opportunity Information: Apply for RFA DK 12 016
Apply for RFA DK 12 016
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Pilot Studies of Candidate Therapies for Chronic Kidney Disease (CKD) (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 Aug 30, 2012 and posted on Aug 30, 2012.
- Applicants must submit their applications by Nov 21, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) County governments For profit organizations other than small businesses Public and State controlled institutions of higher education Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities City or township governments Small businesses.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
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Opportunity Summary:
Pilot Studies of Candidate Therapies for Chronic Kidney Disease (CKD) (U01) is a National Institutes of Health (NIH) funding opportunity designed to move potential CKD treatments closer to definitive, full-scale testing. The core goal is not to run a large, practice-changing trial right away, but to fund smaller, carefully planned pilot studies that work out the most important design details needed for a later randomized controlled trial. The underlying problem this opportunity targets is that many candidate interventions for slowing or reversing CKD progression have shown promise in smaller studies, yet key practical and scientific questions often remain unanswered, such as which specific agent or combination of agents is best, which patient subgroup should be enrolled, what dose and schedule should be used, what data should be collected and how, and which outcomes are most appropriate and feasible for a larger confirmatory study.
This opportunity uses a cooperative agreement mechanism (U01), which signals a more collaborative structure than a standard research grant. In practical terms, applicants should expect an active partnership with NIH during study planning and execution, with an emphasis on coordination, harmonized approaches, and producing results that directly inform the design of later multi-site or larger randomized controlled clinical trials in CKD. The focus is on optimizing trial elements that commonly determine whether a large trial succeeds, including feasibility of recruitment and retention, adherence to the intervention, tolerability, dosing strategies, operational workflows, and the selection and measurement of endpoints that can credibly reflect CKD progression or clinically meaningful benefit.
The funding opportunity number is RFA-DK-12-016, and it is listed under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research). It was posted on August 30, 2012, with an application closing date of November 21, 2012, and it was later archived on December 22, 2012. There is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award.
Eligibility is broad across U.S.-based organizations and includes public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status, with specific provisions for institutions of higher education), state and local governments, tribal governments and tribal organizations, special district governments, public housing authorities/Indian housing authorities, independent school districts, and for-profit organizations (including small businesses). The announcement also explicitly includes categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, among others. Foreign institutions and other non-U.S. entities are not eligible to apply, and foreign components are not allowed under NIH policy for this opportunity.
Overall, the opportunity is best understood as a bridge between early clinical signals and the rigor of a definitive randomized controlled trial in CKD. It supports pilot work meant to reduce uncertainty about trial design choices, improve the chance that a later large trial is efficient and interpretable, and help the field converge on the most promising therapies, the right patient populations, and the most meaningful and measurable outcomes for chronic kidney disease progression. For full details, NIH provided the official announcement page at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-016.html, and general technical help was directed to the NIH Office of Extramural Research (OER) webmaster contacts listed in the notice.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
Pilot Studies of Candidate Therapies for Chronic Kidney Disease (CKD) (U01) is an NIH funding opportunity intended to move promising CKD interventions closer to definitive, full-scale testing. It funds smaller, carefully designed pilot studies rather than large, practice-changing trials.
What is the main goal of the program?
The main goal is to generate the practical and scientific information needed to design a later randomized controlled trial (RCT) in CKD. The emphasis is on answering key design questions before launching a larger confirmatory study.
Is this meant to fund a large clinical trial right away?
No. The opportunity is positioned as a bridge between early clinical signals and a later definitive RCT. It is intended to support pilot work that reduces uncertainty about how a future large trial should be designed and run.
What kinds of questions are these pilot studies expected to answer?
Based on the notice, pilot studies are expected to address questions such as: which agent or combination of agents should be advanced; which CKD patient subgroup should be enrolled; what dose and schedule should be used; what data should be collected and how; and which outcomes are most appropriate and feasible for a larger confirmatory trial.
What trial design elements does NIH want these pilot studies to optimize?
The opportunity highlights optimizing elements that often determine whether a large trial succeeds, including feasibility of recruitment and retention, adherence to the intervention, tolerability, dosing strategies, operational workflows, and selecting/measuring endpoints that credibly reflect CKD progression or clinically meaningful benefit.
What funding mechanism is used, and what does it imply?
The mechanism is a cooperative agreement (U01). This implies a more collaborative structure than a standard research grant, with an active partnership with NIH during planning and execution and an emphasis on coordination and harmonized approaches.
How involved is NIH expected to be during the project?
Applicants should expect active NIH involvement consistent with a U01 cooperative agreement, including collaboration in study planning and execution and a focus on producing results that directly inform the design of later larger and/or multi-site randomized controlled trials in CKD.
What disease area is targeted?
The focus is chronic kidney disease (CKD), specifically pilot studies of candidate therapies aimed at slowing or reversing CKD progression and preparing those interventions for definitive testing.
What is the funding opportunity number and program listing?
The funding opportunity number is RFA-DK-12-016. It is listed under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
When was the opportunity posted and when did it close?
It was posted on August 30, 2012. The application closing date was November 21, 2012. The opportunity was archived on December 22, 2012.
Is cost sharing or matching required?
No. The notice states there is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations and includes: public and private institutions of higher education; nonprofit organizations (including those with and without 501(c)(3) status, with specific provisions for institutions of higher education); state and local governments; tribal governments and tribal organizations; special district governments; public housing authorities/Indian housing authorities; independent school districts; and for-profit organizations (including small businesses).
Are specific institution types explicitly encouraged or included?
Yes. The announcement explicitly includes categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and faith-based or community-based organizations, among others.
Are foreign institutions eligible to apply?
No. Foreign institutions and other non-U.S. entities are not eligible to apply for this opportunity.
Are foreign components allowed if a U.S. organization applies?
No. The notice indicates that foreign components are not allowed under NIH policy for this opportunity.
What is the practical value of doing a pilot study under this program?
The program is intended to reduce uncertainty about trial design choices so that a later large trial is more efficient and interpretable. It supports pilot work that helps the field converge on the most promising therapies, the most appropriate patient populations, and outcomes that are meaningful and measurable for CKD progression.
What kinds of outcomes or endpoints does the opportunity emphasize?
It emphasizes selecting and measuring endpoints that can credibly reflect CKD progression or clinically meaningful benefit, and that are appropriate and feasible to use in later larger confirmatory trials.
Where can applicants find the official NIH announcement?
The official NIH announcement page is listed as: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-016.html
Where is general technical help directed for this opportunity?
General technical help is directed to the NIH Office of Extramural Research (OER) webmaster contacts listed in the notice.
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