Notice to Clarify Eligible Populations and to Exclude Diseases Eligible for Study under RFA-DK-16-026, "Kidney Precision Medicine Project -Recruitment Sites (UG3/UH3)"

Notice Number: NOT-DK-16-031

Key Dates
Release Date: October 5, 2016

Related Announcements
RFA-DK-16-026

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Purpose

The purpose of this Notice is to update RFA-DK-16-026, Kidney Precision Medicine Project - Recruitment Sites (UG3/UH3) to clarify that only adult populations are eligible for participation in studies, and to exclude specific diseases (lupus nephritis and glomerulonephritis) from this Funding Opportunity Announcement (FOA) since they are under the scope of other FOAs.

Part 2. Section I., Funding Opportunity Description

Purpose

Currently reads:
Applicant teams should have documented experience with patient recruitment and safely obtaining kidney biopsies for clinical and/or research purposes. The primary objective of the UG3 exploratory phase will be to demonstrate that the site can recruit participants with either AKI or CKD and obtain high-quality research kidney biopsies, while ensuring safety, minimizing risk and conforming to the highest ethical, research and clinical standards. UG3 awards that have met their milestones will be administratively considered by the NIDDK and prioritized for transition to the UH3 implementation phase. UH3 awards will support continued recruitment into successively larger cohort studies. Projects proposed in response to this FOA will require a multidisciplinary team including nephrologists, critical care physicians, primary care physicians, radiologists, pathologists, statisticians, ethicists, patients, and patient advocates. Investigators responding to this FOA must address both the UG3 and UH3 phases. This FOA is intended to support only human studies and applications that include animal or model systems are not responsive.

Modified to read (paragraph added):

Applicant teams should have documented experience with patient recruitment and safely obtaining kidney biopsies for clinical and/or research purposes. The primary objective of the UG3 exploratory phase will be to demonstrate that the site can recruit participants with either AKI or CKD and obtain high-quality research kidney biopsies, while ensuring safety, minimizing risk and conforming to the highest ethical, research and clinical standards. UG3 awards that have met their milestones will be administratively considered by the NIDDK and prioritized for transition to the UH3 implementation phase. UH3 awards will support continued recruitment into successively larger cohort studies. Projects proposed in response to this FOA will require a multidisciplinary team including nephrologists, critical care physicians, primary care physicians, radiologists, pathologists, statisticians, ethicists, patients, and patient advocates. Investigators responding to this FOA must address both the UG3 and UH3 phases. This FOA is intended to support only human studies and applications that include animal or model systems are not responsive.

The Kidney Precision Medicine Project (KPMP) Recruitment Sites aim to recruit adult men and women with either acute kidney injury (AKI) or chronic kidney disease (CKD) for longitudinal cohort studies that include a research kidney biopsy. Pediatric patients are not within the scope of the KPMP. Moreover, any patient groups currently being recruited or studied by other publicly funded consortia obtaining kidney tissue are not within scope.  Specifically, these include lupus nephritis [AMP lupus (http://www.niams.nih.gov/Funding/Funded_Research/AMP_RA_lupus/default.asp)] and glomerulonephritis [NEPTUNE (http://www.neptune-study.org/) and Cure GN (https://curegn.org/)].

All other aspects of this Funding Opportunity Announcement remain the same.

Inquiries

Please direct all inquiries to:

For Chronic Kidney Disease Recruitment Sites:
Michael Flessner, M.D., Ph.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-4901
Email: flessnermf@mail.nih.gov 

For Acute Kidney Injury Recruitment Sites:
Paul L. Kimmel, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-1409
Email: kimmelp@mail.nih.gov