Single Source for the Continuation of the Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Scientific and Data Research Center (U01 Clinical Trial Required)
Can you apply?
This grant is for institutions seeking NIH funding to establish or continue a clinical research center focused on acute kidney injury (AKI) care outcomes and follow-up treatment. Eligible applicants include academic medical centers, research hospitals, and nonprofit research institutions with established clinical research infrastructure and the capacity to conduct multi-site clinical trials. The grant supports U01 Clinical Trial Required applications, which means applicants must be prepared to conduct or participate in clinical trials as a core component of their research. Federal agencies, universities, and foreign institutions may apply, though U.S. institutions typically have competitive advantages. Geographic scope is national and international, allowing qualified institutions worldwide to apply. Supported activities include establishing data research centers, conducting longitudinal patient outcomes studies, managing patient cohorts with AKI history, and generating evidence on optimal post-AKI care strategies.
Key dates
- Sep 3, 2025 Applications open
- Jul 1, 2026 Application deadline in 30 days
- Jan 1, 2027 Award announced
- Feb 1, 2027 Project start
This grant is for institutions seeking NIH funding to establish or continue a clinical research center focused on acute kidney injury (AKI) care outcomes and follow-up treatment. Eligible applicants include academic medical centers, research hospitals, and nonprofit research institutions with established clinical research infrastructure and the capacity to conduct multi-site clinical trials. The grant supports U01 Clinical Trial Required applications, which means applicants must be prepared to conduct or participate in clinical trials as a core component of their research. Federal agencies, universities, and foreign institutions may apply, though U.S. institutions typically have competitive advantages. Geographic scope is national and international, allowing qualified institutions worldwide to apply. Supported activities include establishing data research centers, conducting longitudinal patient outcomes studies, managing patient cohorts with AKI history, and generating evidence on optimal post-AKI care strategies.
Program description
Applications for a 3-year extension/renewal of the Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) clinical trial consortium, which includes three clinical centers (CCs) and one scientific and data research center (SDRC), are requested to fully meet the enrollment targets, complete participant follow-up, and provide resources for data analysis and dissemination of study findings. This NOFO is for the SDRC application.
There is currently no standard of care for patients after hospitalization with acute kidney injury (AKI). Successful completion of the COPE-AKI study will provide key insights that are expected to directly inform improved clinical management strategies and the development of standard of care for Stage 2 and 3 AKI survivors.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for institutions seeking NIH funding to establish or continue a clinical research center focused on acute kidney injury (AKI) care outcomes and follow-up treatment. Eligible applicants include academic medical centers, research hospitals, and nonprofit research institutions with established clinical research infrastructure and the capacity to conduct multi-site clinical trials. The grant supports U01 Clinical Trial Required applications, which means applicants must be prepared to conduct or participate in clinical trials as a core component of their research. Federal agencies, universities, and foreign institutions may apply, though U.S. institutions typically have competitive advantages. Geographic scope is national and international, allowing qualified institutions worldwide to apply. Supported activities include establishing data research centers, conducting longitudinal patient outcomes studies, managing patient cohorts with AKI history, and generating evidence on optimal post-AKI care strategies.
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) application form
- Project narrative/specific aims (typically 10-15 pages)
- Research plan including methodology, clinical trial design, and data management
- Budget and budget justification with institutional cost-share documentation
- Biographical sketches of key personnel (senior key personnel and other significant contributors)
- Current and pending support documentation
- Letters of institutional commitment and/or MOU from partner sites
- IRB approval documentation or commitment to obtain approval
- Data management and security plan
- Patient recruitment and retention plan
- References and subaward budget details (if applicable)
Program contact
- 👤 Ivonne Schulman
- 📧 ivonne.schulman@nih.gov
- 📞 301.435.3350
Funding track record
Recent awards under CFDA 93.847 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$152,979,352
-
$112,529,392
-
$66,521,567
-
$45,186,589
-
$37,867,943
-
$37,490,770
-
$34,242,949
-
$31,624,784
-
$31,124,496
-
$31,065,476
Top States by Funding
- FL 2 awards $184.1M
- MA 6 awards $165.7M
- PA 6 awards $165.0M
- NY 4 awards $143.8M
- MD 2 awards $143.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.847). How funding has trended year over year.
| 2024 | $1,971,472,000 | |
| 2025 | $2,043,166,000 | |
| 2026 est. | $111,289,000 |
FAQ
Who is eligible to apply for this grant?
Academic medical centers, hospitals, research institutions, and universities with established clinical research infrastructure. Applicants must have capacity to conduct clinical trials or clinical research with patient populations.
What type of research does this grant support?
This grant supports establishment of scientific and data research centers focused on caring for patients after acute kidney injury. It requires a clinical trial component and data management infrastructure for longitudinal patient outcomes research.
Is this a single-year or multi-year grant?
This is a continuation/renewal program, suggesting multi-year funding. The specific award period and budget caps are determined by NIH and should be verified in the full NOFO (Notice of Funding Opportunity).
How competitive is this grant?
U01 grants are moderately to highly competitive. Success requires strong preliminary data, experienced research teams, institutional commitment, and clear clinical significance. Competition is typically strong among established research centers.
What is the typical funding range?
NIH U01 grants vary widely, but clinical research centers typically receive $250,000–$500,000+ in annual funding depending on scope. Exact amounts should be confirmed in the NOFO.
💡 Tips for applicants
- Establish clear preliminary data showing the clinical need for post-AKI care research and demonstrate your institution's capacity to recruit and follow patient cohorts longitudinally.
- Design a rigorous data management and informatics plan that shows how you will capture, standardize, and analyze outcomes across your patient population and any partner sites.
- Build a multidisciplinary team including nephrologists, cardiologists, epidemiologists, biostatisticians, and data scientists to strengthen the research design and credibility.
- Clearly articulate the clinical trial component early in your application, as this is required for U01 awards; explain study design, patient enrollment targets, and compliance with IND/IDE requirements if applicable.
- Demonstrate institutional support and commitment through letters of commitment, facilities documentation, and evidence of institutional funding or cost-sharing for research infrastructure and patient recruitment.
⚠️ Common mistakes
Applicants often underestimate the data management and informatics burden required for U01 research centers, leading to underfunded or unrealistic data plans. Another common pitfall is weak preliminary data or insufficient evidence of the clinical problem being addressed. Finally, many applications fail to clearly articulate how the clinical trial component will be executed, including regulatory compliance, recruitment strategy, and patient retention plans.
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