As published in , 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 at the 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 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 at Feinstein. “We look forward to working with Cara Therapeutics to further our research.”
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.