This department offers a grant to establish a network of clinical and data coordinating centers. This grant is for conducting pilot and feasibility studies on novel interventions for End-Stage Renal Disease (ESRD) patients undergoing chronic hemodialysis. Interventions may include anti-inflammatory, device, psychosocial, and combination therapies. Studies will assess safety, feasibility, dosing, and preliminary outcomes. Applicants must propose two sequential studies, ideally with industry collaboration, to develop common protocols. The ultimate goal is to gather data for designing and implementing larger randomized controlled trials. These trials aim to significantly reduce morbidity and mortality, improving outcomes for maintenance hemodialysis patients.
Opportunity ID: 200553
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-DK-12-010 |
| Funding Opportunity Title: | Novel Interventions to Reduce Morbidity and Mortality of Hemodialysis Patients Safety and Other Early Phase Studies (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: | Sep 11, 2012 |
| Last Updated Date: | – |
| Original Closing Date for Applications: | Nov 21, 2012 |
| Current Closing Date for Applications: | Nov 21, 2012 |
| Archive Date: | Dec 22, 2012 |
| Estimated Total Program Funding: | $1,500,000 |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments Public and State controlled institutions of higher education For profit organizations other than small businesses County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education State governments Small businesses Native American tribal governments (Federally recognized) Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts City or township governments |
| Additional Information on Eligibility: | 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| 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. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-12-010.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 | PKG00146170 | Oct 19, 2012 | Nov 21, 2012 | View |
Package 1
Mandatory forms
200553 RR_SF424_1_2-1.2.pdf
200553 PerformanceSite_1_4-1.4.pdf
200553 RR_OtherProjectInfo_1_3-1.3.pdf
200553 RR_KeyPersonExpanded_1_2-1.2.pdf
200553 PHS398_CoverPageSupplement_1_4-1.4.pdf
200553 PHS398_ResearchPlan_1_3-1.3.pdf
200553 PHS398_Checklist_1_3-1.3.pdf
Optional forms
200553 RR_SubawardBudget30-1.2.pdf
200553 PHS398_ModularBudget_1_2-1.2.pdf
200553 RR_Budget-1.1.pdf
200553 PHS_CoverLetter_1_2-1.2.pdf
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