Trial reportThe patient2024
Impact of Difelikefalin on the Health-Related Quality of Life of Haemodialysis Patients with Moderate-To-Severe Chronic Kidney Disease-Associated Pruritus: A Single-Arm Intervention Trial.
Trial report in The patient, 2024. 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 10 papers, 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.
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
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.
- Difelikefalin in the treatment of hemodialysis patients with pruritus: a systematic review and meta-analysis.Frontiers in pharmacology · 2024Pooled it
- Psychometric validation and meaningful change thresholds of the Skindex-10 questionnaire and 5-D Itch scale for assessing itch in patients with chronic kidney disease-associated pruritus.Journal of patient-reported outcomes · 2025Trial
- Exploratory Analysis of Pruritus and Sleep Outcomes After LCR35 Supplementation in Maintenance Hemodialysis: A Randomized, Open-Label Controlled Study.Life (Basel, Switzerland) · 2026Article
- Comparative performance of EQ-5D-5L bolt-ons in China and the Netherlands: results from the EQ-DAPHNIE project.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026Article
- Chronic Kidney Disease-Associated Pruritus in Patients on Home Haemodialysis.Nephrology (Carlton, Vic.) · 2026Article
- Chronic kidney disease associated pruritus and healthcare resource utilization in European hemodialysis patients: results from an electronic patient-reported outcome survey.BMC nephrology · 2025Article
- The efficacy and safety of kappa opioid receptor (KOR) agonists in patients with uraemic pruritus: a systematic review and network meta-analysis.Clinical kidney journal · 2025Article
- CKD-associated pruritus in haemodialysis: a road map for diagnosis and treatment.Clinical kidney journal · 2025Review
- Exploring the content validity of the EQ-5D-5L and four bolt-ons (skin irritation, self-confidence, sleep, social relationships) in atopic dermatitis and chronic urticaria.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Article
- Qualitative evidence on EQ-5D-5L skin irritation and self-confidence bolt-ons in Darier's disease and Hailey-Hailey disease.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 6 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveChronic kidney disease-associated pruritus (CKD-aP) can have a substantial negative impact on health-related quality of life (HRQoL), including an increased risk of depression, anxiety and sleep disturbance. This trial aimed to assess the impact of intravenous difelikefalin on HRQoL in haemodialysis patients with moderate-to-severe CKD-aP.
methodsPost hoc analysis of an open-label, multicentre, single-arm intervention trial assessed pruritus severity and HRQoL at baseline and at 12 weeks of difelikefalin treatment using Worst Itching Intensity Numerical Rating Scale (WI-NRS), Sleep Quality Numeric Rating Scale (SQ-NRS), 5-D itch scale, Skindex-10 scale, EQ-5D-5L with Pruritus Bolt-On (EQ-PSO).
resultsA total of 222 patients received ≥ 1 dose of difelikefalin, and 197 patients completed 12 weeks of difelikefalin treatment. Clinically meaningful changes from baseline to 12 weeks were observed in all disease-specific measures: 73.7% of patients achieved a ≥ 3-point reduction in the weekly mean of 24 h WI-NRS scores and 66% of patients experienced ≥ 3-point improvements in SQ-NRS scores. Improvements were also observed in all Skindex-10 scale and 5-D itch scale domain scores. The percentage of patients reporting no problems in all EQ-PSO domains increased from 1.4 to 24.7% (p < 0.001), respectively. Patients' generic HRQoL EQ-5D-5L mean utility and EQ-5D visual analogue scale scores increased from baseline to 12 weeks: mean changes 0.04 (p = 0.001) and 2.8 (p = 0.046), respectively.
conclusionsPatients undergoing haemodialysis with moderate-to-severe CKD-aP receiving difelikefalin reported experiencing clinically meaningful improvements in both their pruritus symptoms and itch-related QoL. CLINICALTRIALS: gov registration number, NCT03998163; first submitted, 7 May 2019.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.