Observational studyInternational urology and nephrology2026
Real-world effectiveness and tolerability of difelikefalin over 12 months for hemodialysis-associated pruritus.
Observational study in International urology and nephrology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it.
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundChronic kidney disease-associated pruritus (CKD-aP) is a prevalent symptom in hemodialysis (HD) patients, negatively impacting quality of life and sleep. Difelikefalin, a selective κ-opioid receptor agonist, has shown efficacy in short-term trials. We hypothesized that Difelikefalin would demonstrate sustained efficacy and acceptable safety over 12 months in a real-world setting for refractory CKD-aP.
methodsThis retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP. Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months. Pruritus severity (Worst Itch Numeric Rating Scale, WI-NRS), pruritus-related sleep disturbance (Pruritus-Related Sleep Disturbance Scale, PSDS), quality of life (SF-12) and adverse events were assessed at baseline (T0), 6 months (T6), and 12 months (T12).
resultsA significant reduction in WI-NRS scores was observed from baseline (mean 8.00) to T12 (mean 3.92; p = 0.0001). PSDS scores also significantly improved from baseline (mean 2.90) to T12 (mean 1.17; p = 0.002). No significant changes were observed in SF-12 physical or mental component scores. Twelve patients (60%) completed 12 months of treatment. Discontinuation (n = 8, 40%) was due to adverse events (n = 3, 15%; primarily diarrhoea, mild cognitive impairment), mortality (n = 3, 15%; unrelated cardiovascular events), and patient refusal (n = 2, 10%).
conclusionsIn this real-world cohort of HD patients with refractory CKD-aP, 12 months of Difelikefalin treatment significantly reduced pruritus severity and associated sleep disturbance. Despite a 40% discontinuation rate, the safety profile was consistent with previous reports. These findings support Difelikefalin as a long-term therapeutic option, although larger studies are needed to confirm these results.
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