1. health and fitness
2. disease

Division of Nephrology
WINTER – SPRING 2015
CHIEF’S REPORT
www.icahn.mssm.edu/nephrology
Accelerating Science—Advancing Medicine
Integrating clinical services at the seven hospital campuses in the
Mount Sinai Health System presented a rare opportunity to align
and expand our nephrology programs.
Today, in addition to high-volume chronic
kidney disease clinics at each hospital,
we manage five acute and seven chronic
hemodialysis units that treat more than
1,000 patients. We also are well positioned
for an increased shift toward home therapies:
Our peritoneal dialysis program is the largest
in the city, and we will soon launch a new
home hemodialysis program.
The Division established a center for genetic
kidney disease at Mount Sinai Beth Israel,
which will leverage the outstanding resources
available through our Icahn Institute
for Genomics and Multiscale Biology. In
collaboration with other divisions and
departments, we are establishing lupus
nephritis, vasculitis, kidney stone, and
diabetic nephropathy clinics in our health
system.
John Ci-jiang He, MD, PhD, Chief, Division of
Nephrology, Irene and Dr. Arthur M. Fishberg
Professor of Medicine, and Professor of
Pharmacology and Systems Therapeutics
Among research highlights: The faculty
in the Division of Nephrology received
four new R01 grants in 2014, and National
Institutes of Health funding is nearly
$10 million.
We anticipate new and exciting opportunities
as we further integrate our programs.
INNOVATIVE RESEARCH
Facilitating More Efficient, Less Costly Clinical Trials
Cases of acute and chronic kidney diseases
and syndromes have risen significantly.
Despite a better understanding of kidney
pathophysiology, effective treatments are
few. Many trials have not demonstrated
benefit, and there is a pressing need to
find new therapies. Low-risk patient data
dilute the ability to detect signals from new
interventions, but we can facilitate future
trial conduct by enrolling only high-risk
patients. This can be accomplished by:
• Leveraging data capabilities, particularly
the BioMe™ Biobank, a unique collection
of plasma and DNA samples from nearly
30,000 consented patients;
• Incorporating genotypic data with robust
phenotypic clinical data;
• Selectively measuring biomarkers of
inflammation, kidney injury, and fibrosis
that hold promise.
Whether they are smaller efficacy trials or
larger pragmatic trials, the higher event
rates achieved by enrollment of high-risk
Selective Enrollment of “High-Risk” Patients into Clinical Trials
Intervention
Genotype + Biomarker Panel
+ Clinical Variables = XYZ
“High risk”
Randomization
Control
BioMe™
Biobank
Genotype + Biomarker Panel
+ Clinical Variables ≠ XYZ
“Low Risk”
Assess Impact on
Clinical Outcomes
Assess Impact on
Surrogate Biomarkers
(efficacy & safety)
Find New
Therapies for
Kidney Disease
No
enrollment
An outline to attain more efficient
clinical trials by selectively
enrolling high-risk patients
Blood and urine collected and stored in Biobank Repository
individuals will reduce sample size and
duration of follow-up needed to detect the
efficacy of various interventions. This
means more efficient, less costly trials,
says Steven Coca, DO, MS, Associate
Professor of Medicine (Nephrology).
(See figure.)
An additional goal is to identify and validate
the most promising biomarkers as surrogates
for long-term renal and nonrenal clinical
endpoints, and subsequently employ the
biomarkers as early signals for efficacy (or
safety) when conducting Phase 2 trials of
novel interventions.
Icahn School of Medicine at Mount Sinai | One Gustave L. Levy Place, Box 1243 | New York, NY 10029-6574 | www.icahn.mssm.edu/nephrology
CHIEF’S REPORT | WINTER – SPRING 2015
DIVISION OF NEPHROLOGY
NEW DIAGNOSTIC FRONTIERS
Launching a Biopsy Service and Biorepository for Glomerular Disorders
The Division of Nephrology has initiated a
Kidney Biopsy Service and Glomerular Disease
Biorepository to help physicians address an
increase in glomerular disease cases.
Led by Joji Tokita, MD, Assistant Professor
and Clinical Director of Nephrology, the
Kidney Biopsy Service facilitates safe,
efficient real-time ultrasound-guided tissue
procurement for diagnosing primary and
secondary glomerular disorders. The number
of biopsies performed has doubled, with a
safety record and glomerular yield well above
published estimates. It complements the
Glomerular Disease Biorepository directed by
Kirk Campbell, MD, Assistant Professor of
Medicine. This IRB-approved project has
established a repository on consented patients
of banked blood (for serum biomarker and
DNA), urine (supernatant and RNA), and
tissue to support ongoing, actively funded
translational research studies.
These initiatives enhance the quality of care
offered to patients and support efforts to
identify new therapeutic targets and strategies
for glomerular disease.
ADVANCING OUTPATIENT CLINICAL CARE
New Dialysis Unit to Open in Harlem
The number of patients with end-stage renal disease (ESRD) requiring
dialysis continues to grow, and is projected to reach an annual
incident rate of more than 150,000, with prevalent patients adding up
to an all-time high of more than 750,000 per year. With improving
care and greater life expectancy, the volume of elderly patients
requiring dialysis is expected to increase at a much faster rate, too.
Confocal imaging of immuno-fluorescence
staining performed on human kidney cortex.
Left: Non-diseased glomerulus with appropriate
expression of podocyte marker synaptopodin
(red) colabeled with nuclear marker DAPI (blue).
Right: Glomerulus of a patient with focal segmental
glomerulosclerosis showing reduced expression of
synaptopodin in a segmental pattern.
SERVING THE COMMUNITY
Expanding Mount Sinai’s
Home Dialysis Program
The Mount Sinai Kidney Center Home Dialysis Program trains endstage renal disease (ESRD) patients for peritoneal dialysis (PD) or
home hemodialysis (HHD). Since its inception in 1981, the program
has initiated and trained about 800 patients. Currently, 80 PD patients
are being treated, making it the largest program in the New York City
area. Benchmarks for dialysis adequacy, incidence of peritonitis, and
nutritional markers continue to be at or above national standards.
The program is staffed with a medical director, four registered nurses,
a nutritionist, a social worker, and a full-time coordinator. Staff
members visit patients at home at the beginning of therapy, and every
year thereafter, to provide further support.
Building on this success, Mount Sinai recently initiated a Home
Hemodialysis Program (HHD), providing easy-to-use, state-of-the-art
machines.
From left: Members of the Mount Sinai Kidney Center team: Edward Gelfand,
Administrative Director; Vijay Lapsia, MBBS, MD, Medical Director, MSKC;
Yvette Cummings, RN, Associate Director of Nursing; Brian Libed, RN,
Dialysis Nurse; and Tarah Paul, RN, Clinical Coordinator.
To keep pace with increased demand and changing demographics,
Mount Sinai is opening a state-of-the-art outpatient dialysis unit
early this year that will serve Mount Sinai’s predominantly Harlem
patient population. At this new location, which has more than 18,000
square feet of space and 36 stations, the Mount Sinai Kidney Center
team will have the ability to identify and treat more patients, at the
center and in their own homes. Space has also been allocated for an
interventional suite to perform radiological procedures.
Expert nursing care is provided by Magnet Recognition Program®
award-winning nurses in collaboration with an experienced team of
outstanding nephrologists, dietitians, and social workers. A rigorous
quality assurance program also drives superior clinical outcomes at
this site.
Treating Polycystic Kidney Disease
Mount Sinai Beth Israel’s Polycystic Kidney Disease (PKD)
Program has been approved for the Otsuka REPRISE clinical drug
trial to evaluate the safety and efficacy of tolvaptan in autosomal
dominant PKD patients with late stage 2 to early stage 4 chronic
kidney disease. Irina Barash, MD, MS, Assistant Professor of
Medicine (Nephrology), Icahn School of Medicine at Mount Sinai,
is the principal investigator.
Researchers plan to conduct a separate investigational drug
Phase 2 clinical trial by Kadmon Pharmaceuticals. Academic
collaborations include translational research with Rockefeller
University and joint PKD research with investigators from Yale
School of Medicine to conduct a therapeutic multicenter clinical
trial. Mount Sinai intends to establish a PKD biorepository to study
PKD microbiome and other biomarkers of disease progression.
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