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

 

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.

Deleted 12/22/2012 (Archived.) RFA-DK-12-010 Agency: Department of Health and Human Services
Office: National Institutes of Health Cooperative Agreement 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. 11/21/2012 This program does not have cost sharing or matching requirements. NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV
http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-010.html FBOWebmaster@OD.NIH.GOV $1,500,000.00