Opportunity Information: Apply for RFA DK 12 010
Apply for RFA DK 12 010
- The National Institutes of Health in the food and nutrition health sector is offering a public funding opportunity titled "Novel Interventions to Reduce Morbidity and Mortality of Hemodialysis Patients Safety and Other Early Phase Studies (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 Sep 11, 2012 and posted on Sep 11, 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.)
- The funding agency has allocated a total of $1,500,000.00 to eligible and selected applicants.
- Eligible applicants include: For profit organizations other than small businesses Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities City or township governments County governments 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 Independent school districts Private institutions of higher education Small businesses Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education.
- 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:
This grant opportunity, RFA-DK-12-010, is an NIH cooperative agreement (U01) focused on building a coordinated research network to run early phase clinical studies in people with end-stage renal disease who receive chronic maintenance hemodialysis. The central idea is to bring together multiple participating clinical centers and a dedicated data coordinating center so they can rapidly test promising new approaches that might lower the very high illness burden and death rates seen in the dialysis population. Rather than jumping straight to large, expensive definitive trials, the program is designed to generate the practical early evidence needed to decide what is safe, workable, and worth scaling up into full randomized controlled trials.
The studies supported under this FOA are explicitly pilot and feasibility in nature, with an emphasis on safety and the kinds of groundwork questions that must be answered before a larger efficacy trial can be responsibly designed. That includes determining whether an intervention can be delivered reliably in dialysis settings, whether patients can be recruited and retained, and whether the protocol fits the realities of thrice-weekly dialysis care. Where it applies, projects are expected to evaluate dosing and key drug development parameters such as pharmacokinetics and pharmacodynamics. The network is also expected to identify and do preliminary evaluation of outcomes that could later serve as endpoints in larger trials, helping investigators choose measures that are realistic, clinically meaningful, and sensitive to change in the dialysis population.
The FOA encourages a broad range of intervention types as long as they are novel and relevant to reducing morbidity and mortality in hemodialysis patients. Examples called out in the announcement include anti-inflammatory therapies, device-based or procedural interventions, treatments aimed at depression, other psychosocial interventions, and combinations of therapies. This reflects the reality that outcomes in hemodialysis are influenced not only by traditional medical factors like cardiovascular disease and inflammation, but also by treatment delivery, device safety, symptom burden, mental health, adherence, and quality-of-life factors that can indirectly affect hospitalization and survival.
A key structural requirement is that each applicant must propose two studies that will be conducted sequentially over the award period. This sequential design pushes teams to think like a development pipeline: an initial study might focus on safety, tolerability, and feasibility, and the second could refine the approach with improved dosing, better eligibility criteria, stronger adherence strategies, or more targeted outcome assessment based on what was learned first. Because this is a network model, investigators are also expected to collaborate closely and, when appropriate, bring in industry partners to help provide interventions, devices, or technical support needed to meet study goals. In addition, sites are expected to work together through a Steering Committee to implement common study protocols, which helps ensure consistency across centers and makes results more comparable and scalable.
From an administrative and funding standpoint, this is a discretionary NIH opportunity using the cooperative agreement mechanism, meaning NIH is expected to have substantial involvement beyond standard grants, typically through programmatic coordination, shared governance structures, and network-level decision-making. The estimated total funding listed for the FOA is $1.5 million. The program falls under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), aligning it with the NIH institute mission area covering kidney disease research. There is no cost sharing or matching requirement stated.
Eligibility is broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofits (including both 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and multiple levels of government entities (state, county, city/township, special districts), as well as tribal governments and tribally controlled colleges and universities. The FOA also explicitly notes eligibility for several mission-focused institution categories such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations. At the same time, it clearly excludes non-U.S. entities: foreign institutions are not eligible, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.
In terms of timing and status, the announcement was posted and created on September 11, 2012, with an original and current closing date of November 21, 2012, and an archive date of December 22, 2012. The sponsoring agency is the National Institutes of Health, and the official announcement link is provided through the NIH grants guide. The long-term goal is straightforward: use these early phase, carefully coordinated studies to produce the safety, feasibility, dosing, and outcome data needed to confidently design and launch one or more large-scale randomized controlled trials aimed at meaningfully reducing hospitalization, complications, and mortality among patients receiving maintenance hemodialysis.
Frequently Asked Questions (FAQ)
What is the grant opportunity RFA-DK-12-010?
RFA-DK-12-010 is an NIH funding opportunity for a cooperative agreement (U01) focused on creating a coordinated research network to run early phase clinical studies in people with end-stage renal disease (ESRD) who receive chronic maintenance hemodialysis.
What is the main purpose of this program?
The program is designed to bring together multiple clinical centers and a dedicated data coordinating center so the network can rapidly test promising, novel approaches that may reduce the high illness burden and mortality seen in the hemodialysis population. The emphasis is on generating practical early evidence (safety, feasibility, and related groundwork) before moving to large, definitive randomized controlled trials.
What type of NIH award mechanism is being used?
This opportunity uses the NIH cooperative agreement mechanism (U01). Under a cooperative agreement, NIH is expected to have substantial involvement beyond what is typical for standard research grants, often including programmatic coordination, shared governance, and network-level decision-making.
What kinds of studies are supported under this FOA?
The FOA supports pilot and feasibility clinical studies. These are early phase studies aimed at answering critical preliminary questions needed before a larger efficacy trial can be responsibly designed and launched.
Is the goal to fund large definitive randomized controlled trials (RCTs) right away?
No. The FOA is explicitly focused on early phase pilot and feasibility work rather than immediate large, expensive definitive trials. The intended role of these studies is to generate early evidence to inform whether, how, and what to scale into later RCTs.
Who is the target patient population for the research?
The target population is people with end-stage renal disease who are receiving chronic maintenance hemodialysis.
What are the key scientific questions these early phase studies should address?
Based on the FOA description, studies should prioritize safety and feasibility questions such as whether an intervention can be delivered reliably in dialysis settings, whether patients can be recruited and retained, and whether a protocol fits the realities of thrice-weekly dialysis care.
Are safety and feasibility emphasized more than efficacy?
Yes. The FOA highlights safety and the practical groundwork questions that must be answered before designing a larger efficacy trial, including operational fit within routine dialysis care.
Does the FOA expect attention to dosing and drug development considerations?
Yes, where applicable. Projects are expected to evaluate dosing and key drug development parameters such as pharmacokinetics (PK) and pharmacodynamics (PD).
What does the FOA say about outcomes and endpoints?
The network is expected to identify and do preliminary evaluation of outcomes that could later serve as endpoints in larger trials. This is intended to help investigators choose measures that are realistic, clinically meaningful, and sensitive to change in the dialysis population.
What types of interventions are encouraged?
The FOA encourages a broad range of novel interventions relevant to reducing morbidity and mortality in hemodialysis patients. Examples explicitly mentioned include anti-inflammatory therapies, device-based or procedural interventions, treatments aimed at depression, psychosocial interventions, and combinations of therapies.
Why does the FOA include psychosocial and mental health interventions as examples?
The FOA reflects that hemodialysis outcomes are influenced not only by medical factors (such as cardiovascular disease and inflammation) but also by treatment delivery, device safety, symptom burden, mental health, adherence, and quality-of-life factors that can indirectly affect hospitalization and survival.
Is a network structure required, or can a single site apply on its own?
The FOA is centered on building a coordinated network that includes multiple participating clinical centers and a dedicated data coordinating center. The described structure emphasizes coordination across centers and standardized implementation through network governance.
What is the role of a data coordinating center in this program?
The FOA specifies a dedicated data coordinating center as part of the network model. Its role, in the context provided, is to support coordinated multi-center early phase studies so results can be consistent, comparable, and scalable across participating sites.
How many studies must an applicant propose?
Each applicant must propose two studies.
Do the two proposed studies need to be done in a particular order?
Yes. The FOA requires that the two studies be conducted sequentially over the award period.
What is the rationale for requiring two sequential studies?
The sequential design is meant to function like a development pipeline. The first study can focus on safety, tolerability, and feasibility, and the second can refine the approach using lessons learned (for example, improved dosing, better eligibility criteria, stronger adherence strategies, or more targeted outcome assessment).
Are applicants expected to collaborate with other investigators and sites?
Yes. The FOA describes a coordinated network approach with close collaboration among investigators and sites, including working together to implement common study protocols.
Does the FOA mention any shared governance or committees?
Yes. The FOA notes that sites are expected to work together through a Steering Committee to implement common study protocols, helping ensure consistency across centers.
Are industry partners allowed or encouraged?
Yes. The FOA indicates investigators are expected to collaborate closely and, when appropriate, bring in industry partners to provide interventions, devices, or technical support needed to meet study goals.
What is the estimated total funding level for this FOA?
The FOA lists an estimated total funding amount of $1.5 million.
Is cost sharing or matching required?
No cost sharing or matching requirement is stated in the information provided.
What is the CFDA number associated with this program?
The program is listed under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
Which federal agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What organizations are eligible to apply?
Eligibility is broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofit organizations (including 501(c)(3) and certain non-501(c)(3) entities), for-profit organizations (including small businesses), and various government entities (state, county, city/township, and special districts), as well as tribal governments and tribally controlled colleges and universities.
Are minority-serving institutions and community-based organizations included in eligibility?
Yes. The FOA explicitly notes eligibility for institution categories such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations.
Are foreign organizations eligible to apply?
No. The FOA excludes non-U.S. entities. Foreign institutions are not eligible, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.
What are the key dates for this opportunity?
The announcement was posted and created on September 11, 2012. The original and current closing date is November 21, 2012. The archive date is December 22, 2012.
Is this opportunity still open based on the dates provided?
Based on the provided closing date (November 21, 2012) and archive date (December 22, 2012), this opportunity is not open.
What is the long-term goal of funding this network?
The long-term goal is to use coordinated early phase studies to produce safety, feasibility, dosing, and outcome data needed to confidently design and launch one or more large-scale randomized controlled trials aimed at reducing hospitalization, complications, and mortality among patients receiving maintenance hemodialysis.
What makes this FOA different from a typical single-project clinical study grant?
From the information provided, key distinguishing features include the cooperative agreement (U01) structure with substantial NIH involvement, a required coordinated network model (clinical centers plus a data coordinating center), shared governance through a Steering Committee, and the requirement to propose two sequential studies that build on each other.
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