Amendment: RFA-AI-08-015 Clinical Trials in Organ Transplantation (CTOT) (U01)

Notice Number: NOT-AI-08-067

Key Dates
Release Date: September 25, 2008

Issued by
National Institute of Allergy and Infectious Diseases (NIAID) (


The National Institute of Allergy and Infectious Diseases has amended RFA number AI-08-015 (, entitled “Clinical Trials in Organ Transplantation (CTOT)(U01)”, with regard to language Under Section IV: Application and Submission Information, Item 6: Other Submission Requirements & Information. Specifically, under item 2. Research Plan; a. Concept proposals for clinical studies, the RFA states:

“The application must include a detailed concept proposal for one or more interventional or observational clinical studies, each of which will have associated mechanistic studies that meet the objectives and scope of this FOA. Proposed studies must address questions with broad relevance in the field of transplantation. Applicants may propose either (1) a single study with a target population that includes recipients of different organs (e.g., kidney transplant recipients AND liver transplant recipients), or (2) two studies, each of which targets recipients of a single organ (e.g., a study of heart transplant recipients, and another study of pancreas transplant recipients). The applicant must explain how the results will have a broad impact on the field of transplantation, and must address any relevant health disparity issues. The proposed study or studies must not exceed the clinical and scientific resources of the applicant’s team of institutions (e.g., the applicant group must be able to recruit the required number of study subjects from within their own institutions) and must not exceed 5 years in duration.”

For further clarification NIAID is adding the following language to the above paragraph: The application must propose to study two different transplanted organs; e.g., kidney and lung, heart and kidney, liver and heart, etc. This can be accomplished with either a single study involving 2 different organs, OR with two separate studies, each of which addresses a single organ (but not the same organ in both studies.)


Direct inquiries regarding this Notice to:

Nancy D. Bridges, M.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Disease
Room 3035, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 451-4406
FAX: (301)480-0693

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