Department of Health
and Human Services (HHS)
and Human Services (HHS)
August 25, 2020
RFA-DK-20-011 - Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) – Clinical Centers (U01 Clinical Trial Required)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
On July 7, 2020, the NIDDK issued Funding Opportunity Announcement (FOA) RFA-DK-20-011 “Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) – Clinical Centers (U01 Clinical Trial Required)".
This Notice provides details for applicants regarding study population eligibility requirements. This FOA is limited to the adult population. The following sections of the FOA are revised accordingly:
Funding Opportunity Purpose
Current Language
There is limited evidence to inform recommendations for processes of care or therapeutic interventions targeting progression of kidney disease and the associated morbidity and mortality in AKI survivors. This is a missed opportunity to prevent chronic disease and premature death.
The Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Consortium composed of 3 to 4 Clinical Centers (CCs) and a Scientific and Data Research Center (SDRC) will develop and test interventions that aim to reduce morbidity compared with usual care in Stage 2 and 3 AKI survivors.
Revised Language
There is limited evidence to inform recommendations for processes of care or therapeutic interventions targeting progression of kidney disease and the associated morbidity and mortality in adult AKI survivors. This is a missed opportunity to prevent chronic disease and premature death.
The Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Consortium composed of 3 to 4 Clinical Centers (CCs) and a Scientific and Data Research Center (SDRC) will develop and test interventions that aim to reduce morbidity compared with usual care in adult Stage 2 and 3 AKI survivors.
Part 2. Section I. Funding Opportunity Description
Research Objectives
Current Language
The ‘Caring for OutPatiEnts after Acute Kidney Injury’ (COPE-AKI)’ Consortium intends to develop and test interventions that aim to reduce morbidity compared with usual care in patients after hospitalization with Stage 2 and 3 AKI. Whether a medical intervention in AKI survivors, such as nephrology clinic follow-up education and clinical care and therapy with available treatments, can improve outcomes is unknown in this population.
Revised Language
The ‘Caring for OutPatiEnts after Acute Kidney Injury’ (COPE-AKI)’ Consortium intends to develop and test interventions that aim to reduce morbidity compared with usual care in adult patients after hospitalization with Stage 2 and 3 AKI. Whether a medical intervention in adult AKI survivors, such as nephrology clinic follow-up education and clinical care and therapy with available treatments, can improve outcomes is unknown in this population.
The intent of this FOA is to focus on the adult population and their presentation of AKI during and after hospitalization. We appreciate that children also experience AKI; however, the causes, complications, outcomes, and course are different compared to adults. While it is equally important to examine these factors in the pediatric population, the inclusion of pediatric patients in the study solicited by this FOA would introduce sufficient heterogeneity as to make robust conclusions about pediatric AKI difficult. Therefore, this FOA is limited to adult participants.
All other aspects of this FOA remain the same.
Ivonne H. Schulman, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-385-5744
Email: [email protected]