Research Updates in Kidney and Urologic Health
Two Researchers Join DKUHD
Robert A. Star, M.D., a nephrologist with extensive experience in renal transport mechanisms and acute renal failure, has joined the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) as a senior investigator and scientific advisor to extramural programs for the Division of Kidney, Urologic, and Hematologic Diseases. Dr. Star comes from the faculty of the University of Texas Southwestern School of Medicine.
No stranger to the National Institutes of Health (NIH) campus, Dr. Star began his career in medicine in 1983 with a postdoctoral fellowship at the National Heart, Lung, and Blood Institute, where he worked on kidney and electrolyte metabolism. He graduated cum laude from the Harvard Medical School MIT Joint Program in Health Sciences and Technology after earning his bachelor's degree in applied mathematics with summa cum laude honors at Harvard.
Dr. Star has a special interest in translational research in the diagnosis and treatment of renal disease, particularly acute renal failure (ARF), which lacks a rapid and simple standardized test for earlier diagnosis and more effective treatment. No specific treatment is available for ARF, which has a 50 percent mortality rate.
While at the University of Texas Southwestern Medical Center, Dr. Star and his colleagues also found a pituitary protein, alpha-melanocyte stimulating hormone (a-MSH), to be a very potent anti-inflammatory agent in both laboratory and animal studies. Since much of the tissue injury in animal ARF results from inflammation, a-MSH seemed to have potential for treating that condition. Further investigation uncovered additional characteristics of this hormone, which might enhance its value in treating ARF. Phase 1 safety and dose-ranging clinical trials are now under way.
Dr. Star has published his work with a-MSH, nitric oxide, and other facets of kidney physiology in more than 50 articles in peer-reviewed journals. He has also written chapters for several nephrology textbooks. In 1998, he was invited by NIH to present his work on a-MSH at the 50th Anniversary of the Laboratory of Kidney and Electrolyte Metabolism. He has also addressed the American Society of Nephrology and other scientific forums.
His strong professional interest in the clinical translation of scientific research has also found expression in his work on the American Heart Association's Program Committee of Kidney in Cardiovascular Disease. He contributes to the American Heart Association newsletter, Kidney in Cardiovascular Disease, as well.
Since coming to NIDDK, Dr. Star has established the Renal Diagnostic and Therapeutic Unit. He envisions the long-term goals of this unit to be "to find markers to detect human ARF and to discover therapies to treat and prevent ARF that also enhance the safety and reduce the waiting time for renal transplantation."
Monica Liebert, Ph.D., joined DKUHD in February 2000 to direct the urology basic science program. Dr. Liebert comes to NIH from the University of Texas-M.D. Anderson Cancer Center in Houston, where she served as associate professor in the urology and cell biology departments since 1994. She also served as an associate professor of surgery in the urology division at the University
of Texas Health Sciences Center at Houston.
Dr. Liebert earned her bachelor's degree with distinction in medical technology at the University of Wisconsin-Madison and her Ph.D. in experimental pathology at the University of Pittsburgh, where she was designated a "University Scholar." After an American Cancer Society-supported postdoctoral fellowship in urologic surgery at the University of Pittsburgh, she joined the University of Michigan Medical Center in 1984 as a laboratory director, leaving in 1994 as associate research scientist and assistant professor of surgery/urology.
Dr. Leibert has received several honors and awards, including the Interstitial Cystitis Association Service Award in 1993. She has served on a number of advisory and review committees, such as NIDDK's Biological Resources Advisory Committee and the American Cancer Society's Cell Structure and Metastasis Panel Review Panel. She was also deputy director of the prostate cancer program for the congressionally directed medical research programs of the U.S. Army from 1997 to 1999.
Dr. Liebert has written or contributed to more than 70 journal articles and book chapters. Her research focuses on bladder cancer and urothelial differentiation, and she is continuing her work in these areas in the laboratories of Dr. W. Marston Linehan at the Urologic Oncology Branch of the National Cancer Institute.
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National Institutes of Health Launches ClinicalTrials.gov
Database Gives Public Easy Access to Information About Research Studies
The National Institutes of Health (NIH) has launched the first phase of a consumer-friendly database, ClinicalTrials.gov, which contains information on more than 4,000 Federal and private medical studies involving patients and others at more than 47,000 locations nationwide. The new database may be reached at ClinicalTrials.gov on the Internet.
Clinical trials are medical research studies that seek to evaluate the safety and effectiveness of new drugs, medical procedures, or other means of treating, diagnosing, or preventing diseases. This type of research helps investigators learn how people respond to medications or other therapeutic approaches and may lead to new or improved treatments. Trials are conducted when there is
no proven treatment for a particular disease or to test which treatment works best for a disease or condition.
ClinicalTrials.gov provides patients, families, and the public with easy access to information about the location of clinical trials, their design and purpose, criteria for participation, and, in many cases, further information about the disease and treatment under study. Links to those responsible for recruiting participants for each study are also provided.
Acting NIH Director Ruth L. Kirschstein, M.D., said, "Through this new database, NIH offers up-to-date information on promising patient-oriented research on hundreds of diseases and conditions. Most of the 4,000 clinical trials now in the database are funded by NIH Institutes and Centers and result from a long, fruitful partnership between NIH and the American people who support and participate in our work."
NIH's National Library of Medicine (NLM) developed and administers the new database. ClinicalTrials.gov grew out of 1997 legislation that required the Department of Health and Human Services, through the NIH, to broaden the public's access to information about clinical trials on a wide range of diseases by establishing a registry for both federally and privately funded trials "on drugs for serious or life-threatening diseases and conditions" (Section 113, "Information Program on Clinical Trials for Serious or Life-Threatening Diseases," Food and Drug Administration Modernization Act of 1997, Public Law 105–115).
"The project is proceeding in several major phases," noted Alexa T. McCray, Ph.D., who directs the ClinicalTrials.gov project at NLM. "In the first phase we were interested in collecting information primarily about studies that are being funded by NIH, or that are being conducted right here on the NIH campus. With the release of ClinicalTrials.gov, the first phase is well under
way. In the next phase we will include non-NIH-sponsored trials from other Federal agencies and private industry."
ClinicalTrials.gov is a completely confidential web site. No registration or personal identification of any kind is required, and people who search the site will not be contacted by the sponsors of clinical trials or by anyone else.
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New DKUHD Programs for 2000
Through its Division of Kidney, Urologic,
and Hematologic Diseases (DKUHD), the
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) provides leadership for a national research program in kidney and urologic diseases. Each year, DKUHD works with NIDDK's Advisory Council—representing a broad range of non-Federal scientific, educational, and medical institutions—to plan
and develop a set of program initiatives designed to yield fundamental, innovative, and valuable contributions to human health. The following list of DKUHD initiatives for 2000 demonstrates the division's commitment to maintaining the phenomenal progress of recent years in understanding the biological processes that result in kidney and urologic diseases.
Hemodialysis Vascular Access Clinical Trials Consortium
DKUHD has a longstanding interest in research on the care of patients with end-stage renal disease (ESRD). Despite substantial advances in the care of hemodialysis patients over the past decade, this population continues to experience high rates of morbidity and mortality. One important aspect essential to treating hemodialysis patients, namely the establishment and maintenance of access to the central circulation, has recently received increasing attention. While many clinical epidemiological studies have shown that arteriovenous (AV) fistulas are less prone to failure and complications than AV grafts, only about 18 percent of patients with ESRD in 1996 had a functioning AV fistula 60 days after initiating hemodialysis.
To identify effective therapies to reduce the rate of AV graft and fistula failure, NIDDK has invited cooperative agreement applications for investigators to design and implement a series of multicenter, randomized, controlled clinical trials. These cooperative agreements will support a collaborative network of clinical centers and a data coordinating center to conduct well-designed clinical trials over a 5-year period.
Because more than 40 percent of the new cases
of ESRD are attributed to diabetes mellitus and because both AV fistulas and AV grafts are more likely to fail in such patients, special emphasis will be given to seeing that at least 50 percent of the patients recruited have diabetes, in order to permit adequate subgroup and comparative analyses.
To view the full RFA for this program, go to grants.nih.gov/grants/guide/rfa-files/RFA-DK-00-012.html on the Internet. For more information or clarification, contact
John W. Kusek, Ph.D.
NIDDK DKUHD
6707 Democracy Boulevard, Room 617
MSC 5458
Bethesda, MD 20892–5458
Phone: 301–594–7735
Fax: 301–480–3510
Email: kusekj@ep.niddk.nih.gov
Gastrointestinal and Renal Complications of Foodborne Illness
NIDDK, in partnership with the American Digestive Health Foundation, has invited experienced and new investigators to submit research grant applications to pursue basic and clinical investigations to further the understanding of foodborne illnesses and especially the gastrointestinal disease and renal injury of Escherichia coli 015:H7-induced hemolytic uremic syndrome. This program will foster and extend understanding of the pathogenesis and pathophysiology of foodborne disease, including the mechanisms by which bacterial toxins induce endothelial cell damage and renal injury and bacterial, viral, and fungal organisms and products cause gastrointestinal and extragastrointestinal injury.
Other areas with the potential for further investigation include genetic factors that determine gastrointestinal as well as systemic disease expression; markers of genetic susceptibility to complications of foodborne disease; the natural history and epidemiology of the enteric infection and its extraintestinal manifestations; the risk factors for acquiring, transmitting, and expressing foodborne disease, particularly in children and older people; human markers of genetic susceptibility to complications of foodborne disease; developing experimental models of foodborne diseases; and identifying and testing interventions that might lead to improved management of gastrointestinal disease and extragastrointestinal complications. Developing new diagnostic and therapeutic techniques that could lead to early medical intervention and prevention of complications of foodborne illnesses is particularly important.
The American Digestive Health Foundation—a cooperative effort of the American Gastroenterological Association, the American Society of Gastrointestinal Endoscopy, and the American Association for the Study of Liver Diseases—is cosponsoring this solicitation and will be providing partial funding through NIH for the direct costs of the portfolio of grants that will be supported under this initiative.
The full RFA for this program can be viewed at grants.nih.gov/grants/guide/rfa-files/RFA-DK-00-005.html on the Internet. For more information, contact
Gladys Hirschman, M.D.
Director, Chronic Renal Diseases and Pediatric Nephrology Program
NIDDK DKUHD
6707 Democracy Boulevard, Room 609
MSC 5458
Bethesda, MD 20892–5458
Phone: 301–594–7717
Fax: 301–480–3510
Email: gladys_hirschman@nih.gov
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NIDDK Web Site Redesigned for Enhanced Usability
To coincide with its 50th anniversary year, NIDDK has redesigned its web site. Added features  include an "A to Z" list of all publications available on the site and a dynamic "What's New" area on the front page. Usability testing and comments have been evaluated to create
an intuitive site, and features were added to make it more accessible to people with disabilities. Users will notice that the new look is dominated by text, not graphics. Current trends in web design are much more sensitive to audience needs for information—rather than entertainment—and task-oriented sites like NIDDK's are now less likely to include many graphics.
NIDDK web site users include biomedical researchers, patients, health professionals, and members of the media. They may use the site to obtain requests for applications, clinical trials listings, health publications, or NIDDK press releases.
To transmit your opinions about the usability of the new web site, fill out and submit the online comment form.
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