Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA) (U01 Clinical Trial Optional) | RFA AI 20 029

Opportunity Information: Apply for RFA AI 20 029

The Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA) funding opportunity (RFA AI 20 029) is an NIH cooperative agreement (U01, clinical trial optional) designed to build a coordinated clinical studies program focused on improving long-term outcomes after transplantation in both pediatric and adult patients. The program is centered on reducing the major drivers of poor post-transplant outcomes, especially immune-related complications (such as rejection and other immune-mediated injury) and infection-related morbidity and mortality that can arise from immunosuppression and the transplant process itself. In practical terms, the FOA is looking for teams that can run well-organized, multi-site transplant studies that produce actionable evidence to improve patient survival, graft function, and quality of life over the long term.

CTOT-CA supports cooperative, multi-institutional consortia to conduct either interventional clinical trials (Phase 1, 2, or 3) or observational clinical studies in a broad range of allotransplantation areas. This includes thoracic organ transplantation (such as heart and lung), abdominal organ transplantation (such as kidney, liver, pancreas, and intestine), vascularized composite tissue allotransplantation (for example, hand or face transplants), and cellular replacement approaches. The emphasis on both trials and observational studies means applicants can propose rigorous evaluations of new or optimized therapeutic strategies, monitoring approaches, immunosuppression modifications, tolerance-induction concepts, infection prevention strategies, or other clinically meaningful interventions, as well as high-quality prospective observational work when that is the most appropriate design for the question.

A defining requirement of this FOA is that each applicant institution must apply on behalf of a consortium that includes two or more clinical sites. That structure reflects the reality that many transplant questions require larger and more diverse patient populations than a single center can provide, and it pushes applicants to demonstrate strong multi-site coordination, consistent clinical protocols, and the operational capacity to recruit, follow, and analyze transplant cohorts across institutions. Because the award mechanism is a cooperative agreement, projects are expected to operate in close collaboration with NIH program leadership, which typically means more active federal involvement than a standard grant in areas such as study oversight, milestone tracking, and coordination across the broader CTOT-CA program.

Another core feature is the required pairing of every clinical study with mechanistic investigations. Each proposed trial or observational study must include associated mechanistic studies focused on immune-mediated processes directly relevant to the clinical question being asked. This requirement is meant to ensure that CTOT-CA awards do not only measure whether an intervention works, but also help explain why it works (or fails), for whom it works best, and what biological pathways or biomarkers predict outcomes. In the transplant context, that can include immune monitoring, immunogenetics, donor-recipient immune interactions, signatures of rejection risk, immune tolerance markers, correlates of infection susceptibility, and other mechanistic endpoints that connect clinical events with underlying immune biology. The broader intent is to accelerate progress by integrating patient-oriented outcomes with deep biological insight, ultimately enabling more individualized, safer, and more durable transplant management.

Eligibility is broad and includes many U.S.-based organization types such as state, county, and local governments; public and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses) and small businesses; independent school districts; special district governments; and various Native American tribal governments and organizations. The FOA also explicitly highlights additional eligible applicant categories that NIH often seeks to include in research participation, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, the FOA makes clear that non-U.S. (foreign) institutions are not eligible to apply as applicant organizations, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components as defined under the NIH Grants Policy Statement are allowed, meaning certain project elements can involve international collaborations or activities if they meet NIH policy requirements and are justified within the application.

Administratively, the opportunity is categorized as discretionary funding under the health activity area, with CFDA number 93.855, and is administered by NIH. The original application closing date listed for this specific announcement was October 9, 2020, and the FOA was created on April 15, 2020. While the summary provided does not include an award ceiling or expected number of awards, the key take-home point is that NIH is using this FOA to assemble strong, multi-center transplant research teams capable of running complex clinical studies that also deliver mechanistic immune insights, with the end goal of lowering rejection and infection burdens and improving the long-term trajectory of transplant recipients across organ types and age groups.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA) (U01 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2020-04-15.
• Applicants must submit their applications by 2020-10-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, 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, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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