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Kidney Week

Abstract: SA-PO286

Improvement of Itch With Difelikefalin in CKD Patients on Dialysis by Baseline Itch Severity

Session Information

Category: Dialysis

  • 701 Dialysis: Hemodialysis and Frequent Dialysis


  • Weiner, Daniel E., Tufts Medical Center, Boston, Massachusetts, United States
  • Vervloet, Marc G., Amsterdam University Medical Center, Amsterdam, Netherlands
  • Menzaghi, Frederique, Cara Therapeutics Inc, Stamford, Connecticut, United States
  • Wen, Warren, Cara Therapeutics Inc, Stamford, Connecticut, United States
  • Walpen, Sebastian, Vifor Pharma Ltd, Glattbrugg, Zurich, Switzerland
  • Schaufler, Thilo, Vifor Pharma Ltd, Glattbrugg, Zurich, Switzerland
  • Morin, Isabelle, Vifor Pharma Ltd, Glattbrugg, Zurich, Switzerland
  • Germain, Michael J., Baystate Medical Center, Springfield, Massachusetts, United States

Difelikefalin (DFK) is a peripherally restricted κ-opioid receptor agonist that reduces itch severity in patients with chronic kidney disease-associated pruritus (CKD-aP) undergoing hemodialysis (HD). The purpose of this analysis was to determine if baseline severity of itch impacts the efficacy of DFK.


This was a secondary analysis of a multicenter, open-label study (3105) of intravenous DFK treatment (0.5 µg/kg, 3x per week) in patients on HD with moderate-to-severe CKD-aP (worst itch numerical rating scale [WI-NRS] ≥5). Participants were categorized based on itch severity at baseline as assessed by WI-NRS scores as either moderate (WI-NRS <7) or severe (WI-NRS ≥7). Patients were treated for 12 weeks and mean change in WI-NRS from baseline to the end of week 12 was determined.


Among 222 participants, 70 patients had moderate pruritus (mean ±standard deviation WI-NRS: 6.0 ±0.5) and 152 patients had severe pruritus (8.3 ±0.9) at baseline. Patients with moderate and severe itch at baseline reported on average mild pruritus (WI-NRS <4) at Week 12 (2.9 ±2.2 and 3.1 ±2.3) following an improvement of -3.0 ±2.0 and -5.2 ±2.4 points, respectively, with similar relative improvements in the means from baseline of 51.7% and 62.7%, respectively (Figure).


Following 12 weeks’ treatment with DFK, itch was on average reduced to mild intensity in patients with both moderate and severe disease at baseline. Together, these data suggest that DFK effectively reduces itch severity in patients with CKD-aP on HD, irrespective of baseline itch severity.


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