Abstract: SA-PO1067
Real-World Effect of Difelikefalin on Missed Dialysis Treatment Burden in Adult Patients on Hemodialysis
Session Information
- Kidney Replacement Therapy and Care Delivery Innovations
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Desai, Tejas, CSL, Charlotte, North Carolina, United States
- Soro, Marco, CSL, Rome, Italy
- Gil Mir, Maria, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany
- Arens, Hans-Juergen, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Germany
- Lasky, Rachel A., Renal Research Institute, New York, New York, United States
Background
Chronic kidney disease–associated pruritus (CKD-aP) is common in hemodialysis patients. Difelikefalin (DFK) is the only FDA approved treatment for moderate-to-severe pruritus in this population. However, various non-approved medications are frequently used for treatment of CKD-aP in clinical practice. Additionally, DFK is sometimes used in ways that differ from the approved label, which is based on evidence from randomized clinical trials. Inappropriately managed CKD-aP can significantly impact patients' daily activities and quality of life and can have further consequences, potentially even missing dialysis sessions. This study evaluated real-world missed dialysis treatment burden and different treatment options of CKD-aP.
Methods
This real-world study of electronic records from adult hemodialysis patients treated at Fresenius Kidney Care clinics who initiated DFK between 9/1/2021 and 2/28/2024, had dialysis vintage ≥3 months, and Worst Itch Numerical Rating Scale (WI-NRS) ≥4 at baseline (3 months prior to first DFK prescription). Patients were grouped in four unmatched groups: randomized clinical trial (RCT)-aligned, non-RCT aligned, and non-DFK controls with or without other non-FDA approved anti-pruritus therapy and followed for up to 12 months. The mean baseline age was ~64 years and diabetes and hypertension were common co-morbidities. Multivariate regression models adjusted for demographic and clinical covariates (age, sex, body mass index, dialysis vintage, diabetes Y/N, chronic heart failure Y/N, and ethnicity) were used for analysis.
Results
During follow-up, missed dialysis treatment rates were lowest in the RCT-aligned DFK group. In unadjusted analyses, rates declined from 16.5 to 12.8 per patient-year in the RCT-aligned group, compared with 21.5 to 19.4 in the non-RCT aligned group, 16.6 to 15.9 in the other antipruritic therapy group, and 22.3 to 19.8 in the non-treated group. In adjusted analyses, missed treatment rates were significantly higher in the non-RCT aligned, other antipruritic therapy, and non-treated groups versus the RCT-aligned group (rate ratios 1.50 [1.43–1.57], 1.22 [1.13–1.31], and 1.48 [1.42–1.55], respectively; all p<0.0001).
Conclusion
RCT-aligned DFK treatment in hemodialysis patients was associated with a lower rate of missed dialysis treatments compared with non-RCT aligned or non-FDA approved therapies.
Funding
- Commercial Support – This analysis was funded by Vifor Fresenius Medical Care Renal Pharma Ldt.