Limited Competition for the Continuation of the Halt-Polycystic Kidney Disease Trials Data Coordinating Center (DCC) (U01)

Post Date

May 18th 2012

Application Due Date

July 30th 2012

Funding Opportunity Number

RFA-DK-12-505

CFDA Number(s)

93.847

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Food and Nutrition
Health

Eligibility Categories

Other

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.

Funding

• Estimated Total Funding:

  $1200000

• Award Range:

  $None - $None

Grant 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.Ф The extension will insure the statistical power and significance of the study outcomes. ФThe HALT-PKD Trials are comprised of two studies (A & B) that are both fully enrolled. ФHALT-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. ФHALT-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.

Contact Information

• Agency

  Department of Health and Human Services

• Office:

  National Institutes of Health

• Agency Contact:

  NIH OER Webmaster
  FBOWebmaster@OD.NIH.GOV
  

• Agency Mailing Address:

  If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

• Agency Email Address:

  FBOWebmaster@OD.NIH.GOV

• More Information:

  http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-505.html