| January 23, 2002
Massive Effort to Study the Kidney
Disease Connection to Heart Disease: Penn Leads a Nationwide
$40 Million Study
Termed the "Framingham Study" of Kidney Disease
PA) - It is a curious medical fact that people who suffer
from kidney disease are not only at great risk from
kidney failure requiring dialysis or transplantation,
but are more likely than most to die from heart problems.
Over 10 million Americans suffer from Chronic Renal
Insufficiency (CRI), a disease that, for many sufferers,
leads to death from cardiovascular complications related
to high blood pressure before their kidney disease progresses
To understand the progression of CRI, researchers at
the University of Pennsylvania School of Medicine
will track the health of 3,000 CRI sufferers from seven
clinical sites across the country. The National Institute
of Diabetes and Digestive and Kidney Disease (NIDDK)
of the National Institutes of Health has committed over
$40 million to begin the project and see it through
the first seven years of operation. The funding will
go to seven clinical centers, including Penn, and one
scientific data-coordinating center. The latter, also
based at Penn, will coordinate the scientific conduct
of the study, analyze all study data, and disseminate
their findings. Penn will receive about $17 million
of the grant to fund both the clinical and data coordinating
centers on its campus.
"We will serve as the nerve center of the operation,
collecting data from the individual centers and coordinating
the scientific efforts to sort out the long-term factors
that put CRI sufferers at greater risk." said Harold
I. Feldman, MD, associate professor of medicine
and epidemiology at the Penn Center for Clinical Epidemiology
and Biostatistics (CCEB) and principal investigator
of the CRI Scientific and Data Coordinating Center (CRI-SDCC).
Dr. Feldman is joined by co-principal investigator J.
Richard Landis, PhD, professor of biostatistics
also at the CCEB.
CRI is an important risk factor for end stage renal
disease (ESRD). In 1999, over 300,000 patients were
treated for ESRD in the United States, incurring $11.3
billion in Medicare payments. Among patients with end-stage
kidney disease, heart-related mortality rates are 10
to 20 times that of the general population - and account
for nearly half of all deaths in hemodialysis patients
older than 20.
As one of the nation's leading centers for epidemiological
and biostatistical research, the Penn group will use
its scientific and logistical expertise to coordinate
the multi-institutional effort using web-based data/specimen
collection, quality assurance programs, and data analysis.
"It is a massive undertaking; some have taken to
calling this study the 'Framingham Study' of kidney
disease," said John W. Kusek, PhD, director of
the Clinical Trials Program in the NIDDK Division of
Kidney, Urologic, and Hematologic Diseases. Since 1948,
the Framingham Study has followed the health of over
5000 volunteers from Framingham, Massachusetts, in order
to study the long-term progress of cardiovascular disease.
"Unlike Framingham, this effort will study a less
homogeneous patient population, incorporating the ethnic
and racial groups in which CRI has become more prevalent."
Because CRI is found in disproportionately high numbers
among minority groups, the researchers will make special
efforts to ensure that minorities are adequately represented
in the study. Each of the seven clinical centers will
recruit people with mild to moderate kidney disease
and track how kidney and heart disease progress over
time, while at the same time ensuring that the subjects
receive the current standard of care for their disease.
About one-half of the study participants will also suffer
from diabetes, the cause of about 50% of the cases of
ESRD. The clinical centers plan to complement - but
not replace - the subjects' current source of health
"In each patient, we plan to take a comprehensive
look at the state-of-the-moment in their health,"
said Raymond R. Townsend, MD, professor of medicine
in Penn's Renal-Electrolyte and Hypertension Division,
and Director of one of the seven clinical centers soon
to be opened at the Hospital of the University of Pennsylvania
(HUP). "Over time, these discrete moments, taken
from the best clinical technologies available, will
form a look at kidney disease that is complete from
every possible angle, be it genetic, physical, environmental,
The clinical center at HUP will begin recruiting study
participants late in 2002, as will centers at Case Western
Medical Center, University of Illinois, Johns Hopkins
University - University of Maryland, Kaiser Permanente-San
Francisco, University of Michigan, and Tulane University.
Lifestyle factors will also be examined, including diet,
exercise, smoking, and drinking. Quality of life will
also be studied over time. The researchers will also
give close scrutiny to two factors that have been shown
to affect the progression of CRI - the control of blood
pressure and management of blood sugar in patients with
"We expect that what we learn here will serve patients
with CRI long into the future," said Feldman, "This
study is sure to stimulate new avenues of research,
shaping both our understanding of the mechanisms of
disease as well as the development of new clinical interventions
aimed at reducing the burden of end-stage renal disease
in the U.S."
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