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ArticleClinical kidney journal2025

Difelikefalin for CKD-aP: real world evidence of efficacy and safety in Italian patients.

Filippo Aucella, Simona Zerbi, Maria Pia Monaco, Mario Bonomini, Federico Alberici, Vincenzo Losappio, Giovanni Stallone, Federica Tagliente, Federica Urciuolo, Giuseppe Grandaliano and 3 more

Abstract read
In one paragraph

Article in Clinical kidney journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Filippo AucellaDepartment of Medical Sciences, Nephrology and Dialysis Unit, Research Hospital "Fondazione Casa Sollievo della Sofferenza", San Giovanni Rotondo, FG, Italy.ORCID https://orcid.org/0000-0003-1027-7049
Simona ZerbiUO Nefrologia e Dialisi, Ospedale di Treviglio - Asst Bergamo Ovest, Italy.
Maria Pia MonacoNephrology and Dialysis Unit, Department of Medicine, SS. Annunziata Hospital, G. d'Annunzio University, Chieti, Italy.
Mario BonominiNephrology and Dialysis Unit, Department of Medicine, SS. Annunziata Hospital, G. d'Annunzio University, Chieti, Italy.
Federico AlbericiNephrology Unit, Spedali Civili Hospital, ASST Spedali Civili of Brescia, Italy.ORCID https://orcid.org/0000-0002-1686-5709
Vincenzo LosappioNephrology, Dialysis and Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Italy.
Giovanni StalloneNephrology, Dialysis and Transplantation Unit, Department of Medical and Surgical Sciences, University of Foggia, Italy.
Federica TaglienteDipartimento di Scienze Mediche e Chirurgiche, U.O.C. Nefrologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Federica UrciuoloDipartimento di Scienze Mediche e Chirurgiche, U.O.C. Nefrologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Giuseppe GrandalianoDipartimento di Scienze Mediche e Chirurgiche, U.O.C. Nefrologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Francesco AucellaDepartment of Medical Sciences, Nephrology and Dialysis Unit, Research Hospital "Fondazione Casa Sollievo della Sofferenza", San Giovanni Rotondo, FG, Italy.ORCID https://orcid.org/0009-0009-1643-5213
Maria NardellaDepartment of Medical Sciences, Nephrology and Dialysis Unit, Research Hospital "Fondazione Casa Sollievo della Sofferenza", San Giovanni Rotondo, FG, Italy.
Lucio ManentiAzienda Socio-Sanitaria Liguria 5, Nephrology Unit, La Spezia, Italy.ORCID https://orcid.org/0000-0002-4144-2142

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Chronic kidney disease-associated pruritus (CKD-aP), defined as moderate to severe itching directly related to kidney disease, affects about one-third of haemodialysis patients and has been associated with poor quality of life, poor sleep, depression and increased mortality. Difelikefalin (DFK) is the first-in-class therapy approved by Food and Drug Administration and European Medicines Agency for this condition. The aim of the present study was to evaluate DFK efficacy and safety in a real-world setting in Italy. Methods: We retrospectively collected data for 20 patients treated with DFK in a compassionate manner, before the drug was commercialized, after obtaining approval by the relevant Ethics Committee for each individual case. Mean age and dialysis vintage were 72 ± 11 years and 54 ± 44 months, respectively; basal WI-NRS (24-h Worst Itching Intensity Numerical Rating Scale) score was 8.2 and 5D-ITCH was 18.6. Scratching lesions were detected in 15/20 patients. DFK was administered intravenously with weight-based dosing at the end of each dialysis session. Results: Eighteen of 20 patients were treated for 12 weeks; 2 patients stopped treatment for dizziness ( Conclusions: In haemodialysis patients affected by CKD-aP, DFK is an effective and safe treatment that might clearly improve this distressing and overlooked condition.

Indexed as

chronic kidney disease associated pruritusdifelikefalinend stage renal diseasehaemodialysistherapy

Identifiers

PMID40989995
PMCPMC12451441

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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.