This grant is for the purpose of extending the activities of the Data Coordinating Center (DCC) during the final two years of patient follow-up for the ongoing HALT-Polycystic Kidney Disease (PKD) clinical trials. This extension is crucial to ensure the statistical power and significance of the study outcomes. The HALT-PKD Trials encompass two fully enrolled studies. Study A evaluates the impact of renin-angiotensin-aldosterone system (RAAS) blockade on disease progression in 548 hypertensive PKD patients with GFR > 60 ml/min/1.73 m2, with total kidney volume as the primary endpoint. Study B assesses RAAS blockade in 472 hypertensive PKD patients with GFR 30-60 ml/min/1.73 m2, using a composite endpoint including GFR reduction, ESRD, or death.
Opportunity ID: 171553
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DK-12-505 |
| Funding Opportunity Title: | Limited Competition for the Continuation of the Halt-Polycystic Kidney Disease Trials Data Coordinating Center (DCC) (U01) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Food and Nutrition Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.847 — Diabetes, Digestive, and Kidney Diseases Extramural Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | May 18, 2012 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Jul 30, 2012 |
| Current Closing Date for Applications: | Jul 30, 2012 |
| Archive Date: | Aug 30, 2012 |
| Estimated Total Program Funding: | $1,200,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) |
| Additional Information on Eligibility: | 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. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this limited competition is to extend the activities of the Data Coordinating Center (DCC) during the final two years of patient follow-up of the two ongoing HALT-Polycystic Kidney Disease (PKD) clinical trials. The extension will insure the statistical power and significance of the study outcomes. The HALT-PKD Trials are comprised of two studies (A & B) that are both fully enrolled. HALT-PKD Study A is evaluating the impact of renin-angiotensin-aldosterone system (RAAS) blockade on progression of disease in 548 hypertensive PKD patients with estimated glomerular filtration rate (GFR) > 60ml/min/1.73 m2. The primary endpoint of the study is the percent change in total kidney volume, as measured by magnetic resonance imaging (MRI) over time. HALT-PKD Study B is evaluating the impact of RAAS blockade on progression of disease in 472 hypertensive PKD patients with estimated GFR 30-60 ml/min/1.73 m2. The primary endpoint of Study B is a composite endpoint of time to the 50% reduction of baseline estimated GFR, ESRD (initiation of dialysis or preemptive transplant), or death. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-505.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| 93.847 | ADOBE-FORMS-B2 | ADOBE-FORMS-B2 | PKG00122610 | Jun 30, 2012 | Jul 30, 2012 | View |
Package 1
Mandatory forms
171553 RR_SF424_1_2-1.2.pdf
171553 PerformanceSite_1_4-1.4.pdf
171553 RR_OtherProjectInfo_1_3-1.3.pdf
171553 RR_KeyPersonExpanded_1_2-1.2.pdf
171553 PHS398_CoverPageSupplement_1_4-1.4.pdf
171553 PHS398_ResearchPlan_1_3-1.3.pdf
171553 PHS398_Checklist_1_3-1.3.pdf
Optional forms
171553 RR_SubawardBudget30-1.2.pdf
171553 PHS398_ModularBudget_1_2-1.2.pdf
171553 RR_Budget-1.1.pdf
171553 PHS_CoverLetter_1_2-1.2.pdf
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