MANHASSET, N.Y., Nov. 8, 2019 /PRNewswire/ -- As published in
The New England Journal of Medicine, Feinstein
Institutes for Medical Research investigators found that
patients undergoing hemodialysis who had moderate-to-severe
pruritus experience a significant reduction in itch intensity and
an increase in quality of life after they received the drug
difelikefalin (CR845). The results, part of a phase 3 clinical
trial called KALM-1, were presented by Steven Fishbane, MD, at the American
Society of Nephrology 2019 Kidney Week on November 8.
Kidney failure occurs when the renal system loses the
ability to sufficiently filter waste from the bloodstream, forcing
patients to undergo hemodialysis, or dialysis treatment, to help
purify the blood. About 60 percent of patients on dialysis
experience uraemic pruritus, an intense and generalized itching.
The pruritus is associated with poor sleep quality, depression,
reduced quality of life, risk of infection and potential increased
risk of mortality. Difelikefalin (CR845) is an intravenous agent
being developed by Cara Therapeutics to treat pruritus.
Currently, there is no approved therapy in the United States or Europe.
"The trial's positive results are another step forward in
achieving approval for a therapy to help the many patients
suffering from kidney disease-associated pruritus," said Dr.
Fishbane, the trial's lead investigator and professor in the Health
Innovations & Outcomes Research Institute at Feinstein.
"We look forward to working with Cara Therapeutics to further our
The double-blind, placebo-controlled trial consisted of 378
randomized patients across 56 sites in the US who had
moderate-to-severe pruritus. At the end of the 12-week trial,
difelikefalin resulted in significant improvements and a rapid
reduction in itch intensity among the patients' group versus the
placebo (49.1 percent vs. 27.9
"The findings from Dr. Fishbane's clinical trial give hope for
dialysis patients needing better therapies," said Kevin J. Tracey, CEO and president of the
About the Feinstein Institutes
Feinstein Institutes for Medical Research is the
research arm of Northwell Health, the largest health care provider
and private employer in New York.
Home to 50 research labs, 2,500 clinical research studies and 4,000
researchers and staff, the Feinstein Institutes is raising the
standard of medical innovation through its five institutes of
behavioral science, bioelectronic medicine, cancer, health
innovations and outcomes, and molecular medicine. We're making
breakthroughs in genetics, oncology, brain research, mental health,
autoimmunity, and bioelectronic medicine – a new field of science
that has the potential to revolutionize medicine. For more
information about how we're producing knowledge to cure disease,
Contact: Matthew Libassi
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SOURCE The Feinstein Institutes for Medical Research