Trial reportJournal of renal care2025
Influence of Baseline Itch Severity on Treatment Outcomes With Difelikefalin in Adults With Moderate-to-Severe Pruritus Receiving Maintenance Haemodialysis: An Exploratory Analysis.
Trial report in Journal of renal care, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03998163 (An Open-Label, Multicenter Study to Evaluate the Safety and Effectiveness of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus), which is not on this map. Cited by 1 paper.
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.
An Open-Label, Multicenter Study to Evaluate the Safety and Effectiveness of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Who cites it
1 citing paper in PubMed.
- [Systemic pruritus: focus on hematological, nephrogenic, and hepatobiliary etiologies].Dermatologie (Heidelberg, Germany) · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundDifelikefalin is well-tolerated and reduces itch among adults undergoing haemodialysis (HD), with chronic kidney disease-associated pruritus (CKD-aP).
objectiveThis study aims to explore the influence of baseline itch severity on difelikefalin treatment outcomes.
designStudy 3105 (NCT03998163) was a 12-week, phase 3, single-arm, open-label trial assessing safety and effectiveness of difelikefalin 0.5 µg/kg. We report key endpoints from 3105 by baseline itch severity, determined using the Worst Itching Intensity Numerical Rating Scale (WI-NRS [moderate: WI-NRS < 7; severe: WI-NRS ≥ 7]).
participantsAdult participants undergoing maintenance HD (n = 222) with mild-to-moderate CKD-aP (WI-NRS score ≥ 5 at baseline). MEASUREMENTS: The primary endpoint of 3105 was safety; secondary endpoints included reduction in itch intensity (WI-NRS), and improvements in itch-related quality of life (QoL; 5-D itch scale) and sleep quality (Sleep Quality Numerical Rating Scale).
findingsMean (SD) age was 57.1 (13.3) years; mean (SD) baseline WI-NRS scores were 6.0 (0.5) and 8.3 (0.9) for participants with moderate (n = 70/222) or severe (n = 152/222) itch, respectively. No treatment-related deaths occurred, and there were no safety concerns according to baseline itch severity. By week 12, both groups reported residual 'mild itch' according to mean (SD) WI-NRS scores (moderate: 2.9 [2.2]; severe: 3.1 [2.3]). Approximately one in four participants demonstrated 'complete response' in itch reduction (moderate: 27.1%; severe: 25.0%). Clinically relevant improvements in itch-related QoL and sleep quality occurred among both subgroups.
conclusionsDifelikefalin was well-tolerated and effective in reducing itch in participants with moderate and severe baseline itch, supporting its broad use in a range of individuals on HD with CKD-aP.
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