Pilot and Feasibility Clinical Research Grants in Kidney or Urologic Diseases (R21)

Article excerpt

The Division of Kidney, Urologic, and Hematologic Diseases of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has a longstanding and substantial interest in research concerning the prevention and treatment of kidney or urologic disorders. This program announcement is a reissuance of PAR-04-065, and specifically encourages the submission of applications for pilot and feasibility clinical and translational research studies, including clinical trials, and epidemiologic studies, related to kidney or urologic disease research that address important clinical and translational questions and are potentially of high impact. It is anticipated that applications for pilot and feasibility studies may lead to full-scale clinical studies, including diagnostic strategies, epidemiologic studies, or trials in the diagnosis, prevention, preemption, or treatment of kidney or urologic disease.

These grants may be used for plan, pilot, or implement trials that evaluate pharmacologic, dietary, surgical, or behavioral interventions for the prevention or treatment of kidney or urologic disease. Pilot epidemiologic studies are also encouraged. It is anticipated that these grants will in some cases serve as a basis of planning future multicenter research project grant applications (R01), or for cooperative agreement (U01) applications. The purpose of the planning grant is to provide support for investigators at different institutions to meet and design common protocols, entry criteria, data management systems, analysis plans and pilot data for a clinical trial. This would allow investigators to obtain additional expertise during the trial planning phase in areas such as clinical trial design and statistics to develop an R01 grant to support the clinical trial. A pilot clinical grant to plan a large clinical trial (defined as a trial projected to exceed $500,000 direct costs per year) will only be accepted after prior discussions and approval from NIDDK staff. Both new and experienced investigators in relevant fields and disciplines are encouraged to apply for these grants.

It is anticipated that applications submitted in response to this PAR will focus on clinical studies. Basic laboratory research, studies of laboratory animals, or clinical hematology studies are not appropriate for this program announcement. Studies that do not involve human subjects or are nor human studies will not be supported through this funding opportunity. Applications that focus on experimental models of disease are not appropriate for this PAR, but should be submitted to PA-05-103.

Recent estimates of chronic kidney disease (CKD) in the U.S. population, obtained through analysis of the Third National Health and Nutrition Examination Survey (NHANES III), indicate that it is a common medical problem, affecting [greater than or equal to] 10 million people in the U.S. population. Most cases of CKD observed in the United States occur in the setting of diabetes, hypertension, glomerulonephritis, and polycystic kidney disease. The incidence of end-stage renal disease (ESRD) has also been steadily increasing in the adult US population. U.S. Renal Data System (USRDS) data indicate that from 1992-2003 the number of patients with ESRD has increased from 250 to 338 per million population. Although these rates are finally stabilizing, these increases in ESRD rates reflect a marked increase in patient morbidity and mortality related to underlying kidney disease, as well as a significant increase in use of health care resources to provide appropriate care for affected patients. The increasing rate of ESRD has also markedly increased waiting time for cadaveric transplantation such that the rate of kidney transplants per patient year on dialysis has steadily declined over the last decade, from 6.7 per 100 dialysis patients in 1991 to 4.7 in 2003.

Acute kidney injury (AKI; also called acute renal failure) in hospitalized patients is also a significant problem in the United States. …