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Kidney failure patients find relief in new clinical dialysis drug trial

Feinstein Institutes for Medical Research.

Dr. Steven Fishbane presents clinical trial results at ASN's Kidney Week

MANHASSET, NY —

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 research.”

Difelikefalin trial patients see improvement

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 percent).

“The findings from Dr. Fisbane’s clinical trial give hope for dialysis patients needing better therapies,” said Kevin J. Tracey, CEO and president of the Feinstein Institutes.