Department of Health and Human Services Grant: Extended Support for HALT-PKD Trials Data Coordinating Center

This grant is designed to support the Data Coordinating Center (DCC) for the final two years of patient follow-up in the HALT-Polycystic Kidney Disease (PKD) trials. The goal is to ensure statistical power and significance of outcomes for both fully enrolled studies, HALT-PKD Study A and Study B, evaluating the impact of renin-angiotensin-aldosterone system (RAAS) blockade on the progression of disease in hypertensive PKD patients. Study endpoints include total kidney volume change and a composite endpoint related to renal function. Applications are accepted until July 30, 2012.

Opportunity ID: 171553

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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::
Category of Funding Activity::	Food and Nutrition
Category Explanation::
Expected Number of Awards::
Assistance Listings Number(s)::	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.
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.

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::
Grantor Contact Information::	If you have difficulty accessing the full announcement electronically, please contact:

Version History

Version	Modification Description	Updated Date
Synopsis 1

Package Status

Below are CLOSED Opportunity Package(s) no longer available for this Funding Opportunity:

Package No: 1

Assistance Listings:	93.847
Competition ID:	ADOBE-FORMS-B2
Competition Title:	ADOBE-FORMS-B2
Opportunity Package ID:	PKG00122610
Opening Date:	Jun 30, 2012
Closing Date:	Jul 30, 2012
Agency Contact Information::	Grants Info
Who Can Apply::	Organization Applicants
mendatory_forms	SF424 (R & R) [V1.2] Project/Performance Site Location(s) [V1.4] Research And Related Other Project Information [V1.3] Research And Related Senior/Key Person Profile (Expanded) [V1.2] PHS 398 Cover Page Supplement [V1.4] PHS 398 Research Plan [V1.3] PHS 398 Checklist [V1.3]
optional_forms	R & R Subaward Budget Attachment(s) Form 5 YR 30 ATT [V1.2] PHS 398 Modular Budget [V1.2] Research & Related Budget [V1.1] PHS Cover Letter [V1.2]