Limited Competition for the Continuation of the Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Clinical Centers (U01 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 18, 2026
Can you apply?
This grant is for experienced research institutions and healthcare centers seeking to continue or participate in clinical trial research focused on post-acute kidney injury patient care and outcomes. Applicants must be U.S.-based institutions capable of conducting a U01 clinical trial (indicating the application requires an active human subjects protocol and substantial research infrastructure). Eligible recipients typically include research universities, major medical centers, academic health systems, and organizations with established Clinical and Translational Science Award (CTSA) infrastructure or similar research capability. The program supports continuation of the COPE-AKI clinical centers network, meaning new applicants are less likely to succeed than incumbent sites. Geographic scope is nationwide with preference for sites that contribute to geographically diverse patient populations and diverse research teams.
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Key dates
- Aug 31, 2026 Applications open
- Nov 6, 2026 Application deadline in 18 days
- Jan 1, 2027 Award announced
- Feb 1, 2027 Project start
Program description
This NOFO requests limited competition applications for a 3-year extension of the 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. 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.
This is a forecast for a limited competition Notice of Funding Opportunity (NOFO) that will invite application(s) from eligible organizations to apply. Application(s) will be peer-reviewed and only funded if meritorious.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- NIH Form SF-424 (R&R) and associated forms (PHS 398 or 2590)
- Project narrative/research plan (typically 6–15 pages depending on continuation vs. new application)
- Detailed budget and budget justification for clinical trial operations
- Letters of institutional commitment and support from leadership
- IRB approval letter or evidence of protocol review initiation
- Biosketches of key personnel (PD/PI, coordinators, biostatistician)
- Letters of collaboration from participating clinical sites (if multicenter)
- Data management and quality assurance plan
- Human subjects protection and recruitment/retention plan with diversity considerations
- Preliminary data demonstrating site capacity (enrollment metrics, retention rates, data quality)
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
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$444,814,918
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$200,221,259
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$181,279,494
-
$112,529,392
-
$82,457,560
-
$79,214,478
-
$48,585,892
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$45,186,589
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$37,997,540
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$34,242,949
Top States by Funding
- WA 4 awards $520.0M
- NC 4 awards $293.3M
- FL 3 awards $291.6M
- NY 5 awards $184.3M
- PA 6 awards $176.9M
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 U01 clinical trial grant?
Institutional applicants with established research infrastructure, IRB protocols, and the capacity to conduct clinical trials. This includes research universities, medical schools, teaching hospitals, and academic health systems. Individual researchers cannot apply; applications must be submitted by the institution.
What does "limited competition" mean for this grant?
Limited competition typically means the funding opportunity is restricted to specific institutions or applicants (in this case, likely continuation of existing COPE-AKI sites), making it more difficult for new applicants to compete. Previous awardees may have a competitive advantage.
What are the main research activities this grant supports?
The grant funds clinical trial research examining patient care and outcomes following acute kidney injury. This includes patient recruitment, data collection, clinical assessments, and participation in the multicenter COPE-AKI trial network.
What should a competitive application emphasize?
Strong emphasis on institutional commitment, experienced research staff, established patient recruitment pathways, preliminary data from your site, participation in the broader COPE-AKI network, and plans for diverse participant enrollment. Detailed budget justification for clinical trial operations is essential.
How much funding should I expect and what is the timeline?
U01 grants typically range from $250,000–$500,000+ annually depending on site complexity and patient population. Grant terms are often 5 years for continuation funding. Check NIH RePORTER and the specific RFP for exact funding amounts and duration information.
💡 Tips for applicants
- Emphasize your institution's track record in kidney disease research and clinical trial management; provide metrics on past enrollment and retention rates from similar studies
- Clearly articulate your site's unique value to the COPE-AKI network, including patient population characteristics, geographic region, and ability to reach underrepresented groups
- Budget conservatively but realistically; include line items for research coordinators, patient recruitment, IRB/regulatory compliance, and data management specific to clinical trial operations
- Engage your institutional grants office and Clinical Research Center early; U01 applications require substantial institutional support letters and assurances
- Address potential recruitment and retention challenges upfront; provide concrete mitigation strategies based on your institution's experience with similar patient populations
⚠️ Common mistakes
Applicants often underestimate the administrative and regulatory burden of clinical trial management, leading to unrealistic budgets and timelines. Another frequent error is failing to demonstrate genuine institutional commitment—NIH reviewers scrutinize whether the organization will sustain this work beyond the grant period. Finally, new applicants frequently misunderstand "limited competition" and submit applications despite explicit eligibility restrictions, wasting time and resources; carefully review the RFP to confirm your site is eligible before investing in an application.
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