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 Online

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is NIH Funding Opportunity Announcement (FOA) PA-12-299. It uses the R01 Research Project Grant mechanism and supports investigator-initiated ancillary studies related to kidney disease.

Which NIH institutes sponsor PA-12-299?

The FOA is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) together with the National Heart, Lung, and Blood Institute (NHLBI).

What is the main purpose of this FOA?

The purpose is to fund ancillary studies that leverage information and resources from clinical trials, epidemiological cohorts, and existing administrative or clinical databases to advance knowledge about acute kidney injury (AKI), chronic kidney disease (CKD), and end-stage renal disease (ESRD). The emphasis is on extracting additional scientific value from studies and data resources that already exist or are underway, rather than launching entirely new standalone trials or cohorts.

What does NIH mean by an "ancillary study" in this context?

In this FOA, an ancillary study is research that builds on an existing or ongoing parent study or data resource. It may involve new analyses of existing data, pooling data across studies, applying new statistical approaches, or collecting additional information within an ongoing investigation (such as new measurements, follow-up outcomes, or analyses of additional biospecimens).

Does the parent study need to be NIH-funded?

No. The FOA explicitly welcomes ancillary studies connected to both government-supported and non-government-supported trials and epidemiological studies, as long as the ancillary work is scientifically strong and feasible.

What types of existing resources can be used for an application?

Applications can leverage clinical trials, epidemiological cohorts, and existing administrative or clinical databases. The FOA also encourages analyses of large public-access databases and other established databases, including sources like claims data, electronic health records, registries, or large observational datasets, as long as the methods are rigorous and the kidney-related questions are meaningful.

What kidney conditions are within scope?

The FOA is aimed at research on acute kidney injury (AKI), chronic kidney disease (CKD), and end-stage renal disease (ESRD).

What kinds of research approaches are encouraged?

The FOA encourages a wide range of ancillary approaches, including reanalysis of completed studies, pooling across studies, applying new statistical methods to existing datasets, adding new measurements to ongoing studies, collecting follow-up outcomes, and obtaining or analyzing additional biological specimens.

Can an application propose new analyses of already completed studies?

Yes. The FOA specifically encourages new analyses of completed studies, including reanalysis of existing datasets, pooling information across studies, and testing emerging hypotheses using previously collected information.

Can an application add new data collection to an ongoing study?

Yes. The FOA allows ancillary projects that include additional data collection within ongoing investigations, such as adding new measurements, collecting follow-up outcomes, or obtaining and analyzing additional biological specimens.

Are biomarker studies allowed?

Yes. AKI research is explicitly welcomed, including studies of biomarkers. Examples described in the FOA include evaluating biomarkers for early detection of kidney injury, predicting recovery versus progression to CKD, risk stratification in hospitalized patients, and understanding mechanisms of injury in different clinical contexts.

How might an AKI-focused ancillary study fit this FOA?

Because the mechanism is designed for ancillary use of existing resources, an AKI project could test biomarkers in banked specimens from an existing trial, examine AKI episodes captured in an administrative dataset, or evaluate long-term kidney outcomes after AKI using linked healthcare records.

What scientific topics does the FOA emphasize?

The FOA is geared toward improving understanding of: (1) risk factors contributing to the development of kidney disease, (2) relationships between kidney disease and key comorbid conditions, and (3) outcomes that matter to patients.

Which comorbid conditions are highlighted?

The FOA specifically highlights comorbid illnesses such as malnutrition and cardiovascular disease, reflecting close clinical and biological links between kidney dysfunction, metabolic status, and heart and vascular disease.

Is research on CKD progression included?

Yes. The FOA places emphasis on identifying factors associated with rapid decline in kidney function among people who already have CKD, noting that progression rates vary and may be influenced by biological, behavioral, and healthcare-related factors.

Does the FOA support patient-centered outcomes research?

Yes. Beyond clinical endpoints, the FOA calls for work that clarifies how AKI, CKD, and ESRD affect quality of life and mental and physical functioning, signaling interest in patient-centered outcomes and functional status (not only laboratory measures such as creatinine or eGFR).

Can an ancillary study add kidney-related endpoints to a non-kidney parent study?

Yes. The FOA provides examples such as adding kidney-focused endpoints to an existing cardiovascular or diabetes trial, conducting deeper kidney-related phenotyping within an ongoing cohort, or testing new kidney biomarkers using stored samples.

What grant mechanism is used?

This is an R01 research project grant.

Is cost sharing or matching required?

No. The FOA is described as a discretionary grant with no cost sharing or matching requirement.

What CFDA programs are associated with this FOA?

The FOA lists CFDA 93.837 (cardiovascular diseases research) and CFDA 93.847 (diabetes, digestive, and kidney diseases extramural research), consistent with joint NIDDK/NHLBI sponsorship and the overlap between kidney and cardiometabolic conditions.

Who is eligible to apply?

Eligibility is broad and includes a wide range of U.S.-based organizations, such as public and private institutions of higher education, nonprofits (including those without 501(c)(3) status in some cases), state and local governments, tribal governments and organizations, and for-profit organizations. Small businesses are also listed as eligible.

Are foreign institutions allowed to apply?

Yes. The FOA allows applications from non-U.S. entities and foreign institutions.

Are foreign components of U.S. organizations permitted?

Yes. The FOA permits foreign components of U.S. organizations when consistent with NIH policy, which can be relevant for international cohorts, global trials, and cross-country database research.

When was this FOA posted, and is it still open?

The posting date is September 28, 2012. The listed closing date was January 7, 2016, and the archive date was February 7, 2016. Those dates indicate this specific FOA is archived.

If the FOA is archived, what is still useful about the summary?

Even though PA-12-299 is archived, the summary describes the core intent of this funding line: supporting kidney-focused ancillary studies that capitalize on existing trials, cohorts, and datasets to address questions about AKI, CKD, and ESRD risk, progression, biomarkers, comorbidities, and patient-centered outcomes.