Opportunity Information: Apply for RFA DK 12 509
Apply for RFA DK 12 509
- 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 the Assessment, Serial Evaluation and Subsequent Sequelae of Acute Kidney Injury (ASSESS AKI) Study (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.)
- The funding agency has allocated a total of $2,200,000.00 to eligible and selected applicants.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following 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 funding opportunity (RFA DK 12-509) is a National Institutes of Health (NIH) cooperative agreement (U01) that offers a limited competition to support the continuation and extension of the ASSESS AKI consortium study. The core goal is to keep an existing, well-characterized observational cohort running long enough to generate statistically solid, clinically meaningful findings about what happens to patients after an episode of acute kidney injury (AKI). Rather than launching a new trial, the announcement is focused on extending ongoing consortium activities so that longer-term follow-up data can be collected and analyzed, strengthening the power and credibility of outcome estimates.
The scientific purpose of the extension is to track and compare long-term outcomes in several groups: patients who had an AKI episode and previously had normal kidney function, patients who had an AKI episode in the setting of chronic kidney disease (CKD), and appropriate control participants who did not experience AKI. The study is designed to determine how AKI influences multiple downstream outcomes over time, including (a) long-term kidney functional outcomes (such as progression to CKD, worsening CKD, or other measures of declining renal function), (b) long-term cardiovascular disease outcomes (recognizing the close relationship between kidney injury and cardiovascular risk), (c) patient-centered outcomes such as quality of life and cognitive functioning, and (d) survival. By extending follow-up, the consortium can better capture events that occur months to years after AKI and can more reliably quantify risk trajectories, not just short-term complications.
A major additional emphasis is biomarker evaluation. The announcement highlights assessing the usefulness of putative biomarkers for predicting both short- and long-term outcomes after AKI. In practical terms, this means the consortium intends to determine whether biological signals measured around the time of injury and during follow-up can help forecast who will recover, who will progress to chronic impairment, who may face cardiovascular complications, and who is at higher risk for mortality or functional decline. This biomarker component is important because it can move the field beyond relying only on traditional clinical measures (like serum creatinine) and toward earlier or more accurate risk stratification tools.
From an organizational standpoint, ASSESS AKI is structured as a consortium, consisting of three Participating Clinical Centers (PCCs) and a Data Coordinating Center. This arrangement supports standardized data collection, coordinated follow-up, centralized data management, and consistent analytic approaches across sites. The opportunity notes that an additional site was added as an ancillary study in 2010, indicating that the consortium has already expanded its reach and likely has established infrastructure for integrating multi-site data and ancillary efforts.
Administratively, the opportunity falls under the NIH funding activity category listed as health (with the CFDA number 93.847, associated with Diabetes, Digestive, and Kidney Diseases Extramural Research), and it uses a cooperative agreement mechanism, which generally implies substantial NIH programmatic involvement compared with a standard grant. The announcement was posted on August 30, 2012, with a single closing date of November 21, 2012, and an archive date of December 22, 2012. The estimated total funding amount is $2,200,000, and the announcement explicitly states there is no cost-sharing or matching requirement.
Eligibility is restricted, consistent with the phrase "limited competition." While the posting indicates "Others (see text field entitled Additional Information on Eligibility for clarification)," it clearly excludes non-U.S. (foreign) institutions from applying, excludes non-U.S. components of U.S. organizations, and disallows foreign components as defined by the NIH Grants Policy Statement. In other words, the competition is intended for eligible domestic entities, and, given the nature of a continuation for an established consortium, it is typically aimed at the existing participating sites or otherwise narrowly defined eligible applicants connected to the ongoing ASSESS AKI effort.
Overall, this opportunity is essentially about protecting the value of an already-built cohort and research platform by funding continued follow-up and coordinated analyses. The extension is framed as necessary to ensure statistical power and the significance of the study outcomes, reflecting the reality that long-term endpoints like CKD progression, cardiovascular events, cognitive changes, and mortality require time and adequate sample sizes to evaluate properly. For full details, NIH directed applicants to the complete announcement at the provided NIH Grants Guide link, and technical access issues were routed to the NIH Office of Extramural Research (OER) webmaster contacts.
Frequently Asked Questions (FAQs) - RFA DK 12-509 (ASSESS AKI Consortium Extension, U01)
What is RFA DK 12-509?
RFA DK 12-509 is a National Institutes of Health (NIH) funding opportunity that uses a cooperative agreement mechanism (U01) to support the continuation and extension of the ASSESS AKI consortium study. It is described as a limited competition and is focused on extending an existing observational cohort rather than starting a new study.
What is the main purpose of this funding opportunity?
The main purpose is to keep an existing, well-characterized observational cohort active long enough to generate statistically strong and clinically meaningful results about what happens to patients after an episode of acute kidney injury (AKI). The extension is intended to enable longer-term follow-up, analysis, and stronger outcome estimates.
Is this opportunity meant to launch a new clinical trial?
No. The announcement emphasizes continuation and extension of ongoing consortium activities and follow-up, not the launch of a new trial.
What type of study is being supported?
The funding supports an established observational cohort within the ASSESS AKI consortium, with continued follow-up and coordinated analyses across participating sites.
Why is extended follow-up important for this project?
Extended follow-up helps capture events that occur months to years after AKI and improves the ability to quantify long-term risk trajectories. Outcomes such as chronic kidney disease (CKD) progression, cardiovascular events, cognitive changes, quality of life impacts, and mortality often require longer time horizons and adequate sample sizes to evaluate reliably.
Which participant groups are being tracked and compared?
The extension is designed to track and compare long-term outcomes across several groups: (1) patients who experienced AKI and previously had normal kidney function, (2) patients who experienced AKI in the setting of chronic kidney disease (CKD), and (3) appropriate control participants who did not experience AKI.
What long-term kidney outcomes are of interest?
The study aims to evaluate long-term kidney functional outcomes, including progression to CKD, worsening CKD, and other measures reflecting declining renal function over time.
What cardiovascular outcomes are of interest?
The study includes long-term cardiovascular disease outcomes, reflecting the close relationship between kidney injury and cardiovascular risk.
What patient-centered outcomes are included?
The extension includes patient-centered outcomes such as quality of life and cognitive functioning.
Is survival measured as part of the study?
Yes. Survival is explicitly listed as one of the outcomes the consortium is designed to evaluate over long-term follow-up.
What role do biomarkers play in this funding opportunity?
A major additional emphasis is biomarker evaluation. The consortium is expected to assess the usefulness of putative biomarkers for predicting both short- and long-term outcomes after AKI.
What is the biomarker evaluation intended to predict?
Based on the announcement description, biomarker evaluation is intended to help forecast outcomes such as recovery versus progression to chronic impairment, cardiovascular complications, mortality risk, and functional decline.
Why is biomarker work highlighted in this extension?
The biomarker emphasis is positioned as a way to move beyond reliance on traditional clinical measures (such as serum creatinine) toward earlier or more accurate tools for risk stratification and outcome prediction after AKI.
How is the ASSESS AKI consortium organized?
The consortium is structured to include three Participating Clinical Centers (PCCs) and a Data Coordinating Center. This structure supports standardized data collection, coordinated follow-up, centralized data management, and consistent analytic methods across sites.
Does the announcement mention anything about consortium expansion?
Yes. It notes that an additional site was added as an ancillary study in 2010, suggesting existing infrastructure for incorporating multi-site data and ancillary efforts.
What NIH mechanism is used for this award?
This opportunity uses a cooperative agreement mechanism (U01), which generally indicates substantial NIH programmatic involvement compared with a standard research project grant.
What is the estimated total funding amount?
The estimated total funding amount stated in the announcement is $2,200,000.
Is cost sharing or matching required?
No. The announcement explicitly states there is no cost-sharing or matching requirement.
What is the CFDA number and program area noted for this opportunity?
The opportunity is listed under the health funding activity category with CFDA number 93.847, associated with Diabetes, Digestive, and Kidney Diseases Extramural Research.
When was the opportunity posted and what were the key dates?
The announcement was posted on August 30, 2012. It listed a single closing date of November 21, 2012, and an archive date of December 22, 2012.
How many application due dates were listed?
The announcement indicates a single closing date (November 21, 2012).
Who is eligible to apply?
Eligibility is restricted as a limited competition. The posting indicates "Others (see text field entitled Additional Information on Eligibility for clarification)" and, based on the information provided, the competition is intended for eligible domestic entities and is typically aimed at existing participating sites or otherwise narrowly defined applicants connected to the ongoing ASSESS AKI effort.
Are foreign (non-U.S.) institutions eligible to apply?
No. The announcement explicitly excludes non-U.S. (foreign) institutions from applying.
Are non-U.S. components of U.S. organizations allowed?
No. The announcement excludes non-U.S. components of U.S. organizations.
Are foreign components allowed under this opportunity?
No. It disallows foreign components as defined by the NIH Grants Policy Statement.
What is the overall rationale for funding this extension?
The rationale is to protect and increase the value of an already-built cohort and research platform by funding continued follow-up and coordinated analyses. The extension is framed as necessary to achieve adequate statistical power and to support clinically meaningful long-term conclusions.
Where were applicants directed for full details?
Applicants were directed to the complete announcement in the NIH Grants Guide link referenced in the posting.
Where were technical access issues routed?
Technical access issues were routed to the NIH Office of Extramural Research (OER) webmaster contacts.
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|---|
| Pilot Studies of Candidate Therapies for Chronic Kidney Disease (CKD) (U01) Apply for RFA DK 12 016 Funding Number: RFA DK 12 016 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Expansion of Symptoms of Lower Urinary Tract Dysfunction Research Network (LURN) (U01) Apply for RFA DK 12 017 Funding Number: RFA DK 12 017 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Chronic Renal Insufficiency Cohort (CRIC) Study (U01) Apply for RFA DK 12 508 Funding Number: RFA DK 12 508 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Advancing Clinical Research in Primary Glomerular Diseases (UM1) Apply for RFA DK 12 014 Funding Number: RFA DK 12 014 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Novel Interventions to Reduce Morbidity and Mortality of Hemodialysis Patients Safety and Other Early Phase Studies (U01) Apply for RFA DK 12 010 Funding Number: RFA DK 12 010 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Multidisciplinary K12 Urologic Research (KURe) Career Development Program Apply for RFA DK 12 013 Funding Number: RFA DK 12 013 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $600,000 |
| Limited Competition Small Grant Program for NIDDK K01/K08/K23 Recipients (R03) Apply for PAR 12 285 Funding Number: PAR 12 285 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $50,000 |
| George M. OBrien Urology Cooperative Research Centers Program (U54) Apply for RFA DK 12 009 Funding Number: RFA DK 12 009 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $650,000 |
| Ancillary Studies of Acute Kidney Injury, Chronic Kidney Disease, and End Stage Renal Disease Accessing Information from Clinical Trials, Epidemiological Studies, and Databases (R01) Apply for PA 12 299 Funding Number: PA 12 299 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Early Stage Pharmacological Validation of Novel Targets and Accompanying Pre Therapeutic Leads for Diseases of Interest to the NIDDK (R01) Apply for PAR 13 007 Funding Number: PAR 13 007 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $500,000 |
| New Directions in Hematology Research (SHINE II) (R01) Apply for PAS 13 006 Funding Number: PAS 13 006 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Limited Competition Data Coordinating Center for The Environmental Determinants of Diabetes in the Young (TEDDY) Study (UC4) Apply for RFA DK 12 510 Funding Number: RFA DK 12 510 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Research Using Biosamples from Selected Type 1 Diabetes Clinical Studies (DP3) Apply for PAR 13 013 Funding Number: PAR 13 013 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Developmental Centers for Interdisciplinary Research in Benign Urology (P20) Apply for RFA DK 12 022 Funding Number: RFA DK 12 022 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $200,000 |
| Nociceptive GenitoUrinary Development Molecular Anatomy Projects (nGUDMAP) (U01) Apply for RFA DK 12 024 Funding Number: RFA DK 12 024 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Research Using Subjects From Selected Type 1 Diabetes Clinical Studies (Living Biobank) (DP3) Apply for PAR 13 028 Funding Number: PAR 13 028 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Stimulating Hematology Investigation New Endeavors (SHINE) (R01) Apply for PAS 13 031 Funding Number: PAS 13 031 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Urologic Chronic Pelvic Pain Syndrome (UCPPS) Research (R01) Apply for RFA DK 12 025 Funding Number: RFA DK 12 025 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $250,000 |
| Erythropoiesis Components and Mechanisms (R01) Apply for PA 13 034 Funding Number: PA 13 034 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Diabetes Impact Award Closed Loop Technologies Clinical, Physiological and Behavioral Approaches to Improve Type 1 Diabetes Outcomes (DP3) Apply for RFA DK 12 020 Funding Number: RFA DK 12 020 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
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