Opportunity Information: Apply for RFA DK 12 505
Apply for RFA DK 12 505
- 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 Halt Polycystic Kidney Disease Trials Data Coordinating Center (DCC) (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 May 18, 2012 and posted on May 18, 2012.
- Applicants must submit their applications by Jul 30, 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 $1,200,000.00 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 As this FOA is a limited competition opportunity, only the institution that is the principal employer of the Program Director(s)/Principal Investigator(s) of the HALT Data Coordinating Center is eligible to apply to this FOA. 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The grant opportunity titled "Limited Competition for the Continuation of the HALT Polycystic Kidney Disease Trials Data Coordinating Center (DCC) (U01)" (Funding Opportunity Number RFA-DK-12-505) is a National Institutes of Health cooperative agreement designed to keep the HALT PKD Trials Data Coordinating Center fully operational for the last two years of participant follow-up. The central goal of this extension is to preserve the scientific integrity of the ongoing clinical trials by maintaining adequate statistical power and ensuring that final outcome analyses remain meaningful and interpretable. In practical terms, this continuation supports the coordinated data management, statistical oversight, and trial operations needed to complete follow-up and finalize analyses without losing the ability to detect clinically important differences between study arms.
This opportunity supports the coordinating infrastructure behind two fully enrolled randomized clinical trials collectively known as the HALT Polycystic Kidney Disease (PKD) Trials, made up of Study A and Study B. Both trials examine how renin-angiotensin-aldosterone system (RAAS) blockade affects disease progression in hypertensive patients with PKD, but they focus on different stages of kidney function. Study A includes 548 hypertensive PKD participants with relatively preserved kidney function (estimated GFR at or above 60 ml/min/1.73 m2). Its primary endpoint is the percent change in total kidney volume over time, measured using magnetic resonance imaging (MRI), reflecting an emphasis on structural disease progression. Study B includes 472 hypertensive PKD participants with more reduced kidney function (estimated GFR between 30 and 60 ml/min/1.73 m2). Its primary endpoint is clinical progression captured through a composite time-to-event outcome: time to a 50 percent reduction from baseline estimated GFR, end-stage renal disease (ESRD, defined as starting dialysis or receiving a preemptive transplant), or death. Together, these endpoints are intended to capture both anatomical changes and hard clinical outcomes across different phases of PKD progression.
The award mechanism is a U01 cooperative agreement, which typically means NIH will have substantial programmatic involvement compared with a standard research project grant. While the announcement is categorized broadly under health and is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), the core focus is kidney disease clinical trial coordination. The estimated total funding amount listed is $1,200,000, and the funding period covered by this specific continuation is aimed at the final two years of follow-up rather than launching a new trial or expanding enrollment.
Eligibility is tightly restricted because this is a limited competition. Only the institution that employs the current Program Director(s)/Principal Investigator(s) of the existing HALT Data Coordinating Center is allowed to apply. Foreign institutions are explicitly not eligible, and foreign components of U.S. organizations are not allowed under NIH policy for this announcement. There is no cost sharing or matching requirement. The opportunity was posted on May 18, 2012, with an original and current closing date of July 30, 2012, and it was archived on August 30, 2012, indicating it was a time-limited continuation solicitation rather than an ongoing annual program.
From an operational standpoint, the continuation funding is meant to keep the DCC functioning through the closeout phase when high-quality trial execution is especially important. That includes ensuring consistent follow-up data collection across sites, maintaining data quality control, managing databases, supporting endpoint ascertainment, and conducting or supporting the final statistical analyses tied to the primary endpoints for both Study A and Study B. The basic rationale is that without a stable coordinating center through the final follow-up window, the trials risk incomplete outcome capture or reduced analytic power, which could compromise the ability to draw clear conclusions about the benefits and risks of RAAS blockade strategies in PKD patients.
The full announcement was available through the NIH Grants Guide at the link provided in the source material: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-505.html, and administrative help was directed to the NIH Office of Extramural Research (OER) webmaster contacts listed in the notice.
Frequently Asked Questions (FAQs)
What is the title of this funding opportunity?
The opportunity is titled "Limited Competition for the Continuation of the HALT Polycystic Kidney Disease Trials Data Coordinating Center (DCC) (U01)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-DK-12-505.
What type of award mechanism is being used?
This opportunity uses a U01 cooperative agreement mechanism.
What does it mean that this is a cooperative agreement (U01)?
Based on the announcement description, the U01 mechanism indicates substantial NIH programmatic involvement compared with a standard research project grant. This opportunity is intended to support coordinated trial infrastructure rather than operate like an investigator-initiated project grant.
What is being funded under this continuation opportunity?
The continuation funds the HALT PKD Trials Data Coordinating Center (DCC) so it can remain fully operational for the last two years of participant follow-up and support final outcome analyses.
Is this funding meant to start a new clinical trial or expand enrollment?
No. The continuation is aimed at supporting the final two years of follow-up for two trials that are already fully enrolled, rather than launching a new trial or expanding enrollment.
What is the central goal of this continuation?
The central goal is to preserve the scientific integrity of the ongoing HALT PKD clinical trials by maintaining adequate statistical power and ensuring that final outcome analyses remain meaningful and interpretable through completion of follow-up.
Why is keeping the Data Coordinating Center operating through closeout important?
The continuation is intended to reduce risks such as incomplete outcome capture, reduced analytic power, and compromised interpretability of results. The DCC supports consistent follow-up, data quality control, endpoint ascertainment, and final statistical analyses during a phase when high-quality execution is especially important.
Which clinical trials does the DCC support?
The DCC supports two fully enrolled randomized clinical trials collectively known as the HALT Polycystic Kidney Disease (PKD) Trials: Study A and Study B.
What is the general research focus of the HALT PKD Trials?
Both trials examine how renin-angiotensin-aldosterone system (RAAS) blockade affects disease progression in hypertensive patients with polycystic kidney disease (PKD), focusing on different stages of kidney function.
How many participants are in Study A, and what stage of kidney function does it include?
Study A includes 548 hypertensive PKD participants with relatively preserved kidney function, defined as estimated GFR at or above 60 ml/min/1.73 m2.
What is the primary endpoint for Study A?
The primary endpoint for Study A is the percent change in total kidney volume over time, measured using magnetic resonance imaging (MRI).
How many participants are in Study B, and what stage of kidney function does it include?
Study B includes 472 hypertensive PKD participants with more reduced kidney function, defined as estimated GFR between 30 and 60 ml/min/1.73 m2.
What is the primary endpoint for Study B?
The primary endpoint for Study B is a composite time-to-event outcome: time to a 50 percent reduction from baseline estimated GFR, end-stage renal disease (ESRD, defined as starting dialysis or receiving a preemptive transplant), or death.
How do the endpoints of Study A and Study B differ?
Study A emphasizes structural disease progression (percent change in total kidney volume by MRI), while Study B emphasizes clinical progression using a composite time-to-event endpoint tied to kidney function decline and major clinical outcomes (ESRD or death).
What specific functions does the continuation support at the Data Coordinating Center?
The continuation supports coordinated data management, statistical oversight, and trial operations needed to complete follow-up and finalize analyses. The description also highlights consistent follow-up data collection across sites, data quality control, database management, endpoint ascertainment, and final statistical analyses for both trials.
What is the estimated total funding amount listed for this opportunity?
The estimated total funding amount listed is $1,200,000.
What time period does this continuation funding cover?
This continuation is intended to support the last two years of participant follow-up for the HALT PKD Trials.
Is eligibility open to all institutions?
No. This is a limited competition. Only the institution that employs the current Program Director(s)/Principal Investigator(s) of the existing HALT Data Coordinating Center is eligible to apply.
Are foreign institutions eligible to apply?
No. Foreign institutions are explicitly not eligible for this announcement.
Are foreign components of U.S. organizations allowed?
No. Foreign components of U.S. organizations are not allowed under NIH policy for this announcement.
Is cost sharing or matching required?
No. The opportunity states that there is no cost sharing or matching requirement.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research).
When was the opportunity posted, and what were the close dates?
The opportunity was posted on May 18, 2012. The original closing date and current closing date listed are both July 30, 2012.
Is this opportunity currently active?
No. The notice indicates it was archived on August 30, 2012, reflecting that it was a time-limited continuation solicitation.
Where can the full announcement be found?
The full announcement was available through the NIH Grants Guide at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-505.html.
Who was listed for administrative help in the notice?
Administrative help was directed to the NIH Office of Extramural Research (OER) webmaster contacts listed in the notice.
Browse more opportunities from the same agency: National Institutes of Health
Browse more opportunities from the same category: Food and Nutrition Health
Next opportunity: FY 2013 Funding Opportunity Announcement for Reception and Placement Program
Previous opportunity: Notice of Intent to Single Source Bird Monitoring
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA DK 12 505
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (RFA DK 12 505) also looked into and applied for these:
| Funding Opportunity |
|---|
| Limited Competition for the Continuation of Look AHEAD (Action for Health in Diabetes) Consortium (U01) Apply for RFA DK 12 502 Funding Number: RFA DK 12 502 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Renal Function and Chronic Kidney Disease in Aging (R01) Apply for PA 12 211 Funding Number: PA 12 211 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| George M. OBrien Kidney Research Core Centers (P30) Apply for RFA DK 12 008 Funding Number: RFA DK 12 008 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $750,000 |
| Research Enhancement for NIDDK Hematology Grantees (Admin Supp) Apply for PA 12 242 Funding Number: PA 12 242 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| New Technologies for the Study of Lymphatics in the Digestive and Urinary Systems (R43/R44) Apply for PA 12 258 Funding Number: PA 12 258 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $150,000 |
| Lymphatics in Health and Disease in the Digestive, Urinary, Cardiovascular and Pulmonary Systems (R01) Apply for PAR 12 259 Funding Number: PAR 12 259 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $250,000 |
| Lymphatics in Health and Disease in the Digestive, Cardiovascular and Pulmonary Systems (R21) Apply for PAR 12 260 Funding Number: PAR 12 260 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: $125,000 |
| Ancillary Studies to Major Ongoing Clinical Research Studies to Advance Areas of Scientific Interest within the Mission of the NIDDK (R01) Apply for PAR 12 265 Funding Number: PAR 12 265 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| Limited Competition for the Continuation of the Assessment, Serial Evaluation and Subsequent Sequelae of Acute Kidney Injury (ASSESS AKI) Study (U01) Apply for RFA DK 12 509 Funding Number: RFA DK 12 509 Agency: National Institutes of Health Category: Food and Nutrition Health Funding Amount: Case Dependent |
| 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 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA DK 12 505", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.