Novel Interventions to Reduce Morbidity and Mortality of Hemodialysis Patients Safety and Other Early Phase Studies (U01)

Post Date

September 11th 2012

Application Due Date

November 21st 2012

Funding Opportunity Number

RFA-DK-12-010

CFDA Number(s)

93.847

Funding Instrument Type(s)

Cooperative Agreement

Funding Activity Categories

Food and Nutrition
Health

Eligibility Categories

State Governments
County Governments
City or Township Governments
Special District Governments
Independent School Districts
Public and State Controlled Institutions of Higher Education
Federally Recognized Native American Tribal Governments
Public Housing Authorities or Indian Housing Authorities
Non-Federally Recognized Native American Tribal Organizations
Non-Profits With 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Non-Profits Without 501 (c) (3) Status With The IRS (Except Higher Education Institutions)
Private Institutions of Higher Education
For-Profit Organizations (Except Small Businesses)
Small Businesses
Other

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; 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:

  $1500000

• Award Range:

  $None - $None

Grant Description

The purpose of this Funding Opportunity Announcement (FOA) is to initiate and implement a network of participating clinical centers and a data coordinating center to perform pilot and feasibility studies of novel therapies and procedures, including anti-inflammatory therapies, device or procedural interventions, anti-depressive therapies and other psychosocial interventions, and/or combination therapies, in end-stage renal disease (ESRD) patients undergoing chronic maintenance hemodialysis (HD). Studies will focus on safety; feasibility; identification of dosing, pharmacokinetic, and pharmacodynamic aspects (where appropriate); and identification and preliminary evaluation of potential outcomes. Applicants are required to propose two studies to be performed sequentially over the funding period. When applicable, clinical site investigators will enlist industry collaboration to achieve the goals of the network. Investigators will also work collaboratively to implement common study protocols developed by the Steering Committee. The ultimate goal of this FOA is to obtain the necessary information to design and implement one or more full-scale randomized controlled clinical trials of therapies or interventions to reduce morbidity and mortality in patients undergoing maintenance hemodialysis.

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-12-010.html