Difelikefalin for Hemodialysis Patients with Pruritus in Japan.

Narita I, Tsubakihara Y, Takahashi N, Ebata T, Uchiyama T, Marumo M, Okamura S, Gejyo F

NEJM evidence17 Oct 2023Cited by 6 (Europe PMC)

PMID38320524DOI10.1056/evidoa2300094PepBankPUB-38320524

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In hemodialysis patients at week 4, NRS changes were −2.06 (95% CI −2.45 to −1.66) with difelikefalin versus −1.09 (−1.47 to −0.70) with placebo, a difference of −0.97 (−1.52 to −0.42, P<0.001).
In plain wordsIn hemodialysis patients, difelikefalin reduced itch more than placebo at week 4.
Peptide
Difelikefalin
Outcome
DecreaseWorst Itching Intensity NRS change at week 4
Study
n = 178
Comparator
Placebo
Analysis
Primary
Outcome group
Skin and hair · Skin and wound
Studied dose
0.5 μg/kg three times per week · intravenous · 6 weeksAs given in this study (human).
Measurements
Change from baseline in weekly adjusted mean Worst Itching Intensity NRS score at week 4
−1.09 NRS points
placebo
95% CI of change from baseline in NRS score at week 4
−1.47 to −0.7 NRS points
placebo
Change from baseline in weekly adjusted mean Worst Itching Intensity NRS score at week 4
−2.06 NRS points
difelikefalin
95% CI of change from baseline in NRS score at week 4
−2.45 to −1.66 NRS points
difelikefalin
Between-group difference in NRS change at week 4
−0.97 NRS points
difelikefalin versus placebo
95% CI of between-group difference in NRS change at week 4
−1.52 to −0.42 NRS points
difelikefalin versus placebo
P value for between-group difference
< 0.001 p-value
difelikefalin versus placebo
Source sentences
Summary
The change from baseline in the weekly adjusted mean NRS score (95% confidence interval) at week 4 in the placebo and difelikefalin groups was −1.09 (−1.47 to −0.70) and −2.06 (−2.45 to −1.66), respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
The difference between the groups was −0.97 (−1.52 to −0.42), demonstrating that difelikefalin was superior to placebo (P<0.001).
Summary · context
In this double-blind, placebo-controlled, phase 3 trial in Japan, patients with moderate to severe pruritus were randomly allocated 1:1 to receive either placebo or 0.5 μg/kg of difelikefalin three times per week intravenously for 6 weeks.
Summary · context
The primary end point was change from baseline in the Worst Itching Intensity Numerical Rating Scale (NRS; 0 to 10; higher scores indicate more severe itching) score at week 4.
Report a problemFND-3832052401
02HumanRandomized controlled trialSafety outcome
In hemodialysis patients, treatment-related adverse events occurred in 13 of 89 difelikefalin recipients (15%) versus 3 of 89 placebo recipients (3%).
In plain wordsIn hemodialysis patients, treatment-related adverse events occurred in 15% with difelikefalin versus 3% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseTreatment-related adverse events
Study
n = 178
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
0.5 μg/kg three times per week · intravenous · 6 weeksAs given in this study (human).
Measurements
Patients with treatment-related adverse events
13 patients
difelikefalin group, of 89
Incidence of treatment-related adverse events
15%
difelikefalin group
Patients with treatment-related adverse events
3 patients
placebo group, of 89
Incidence of treatment-related adverse events
3%
placebo group
Source sentences
Summary
The incidence of treatment-related adverse events in the placebo and difelikefalin groups was 3 of 89 patients (3%) and 13 of 89 patients (15%), respectively, of which the majority in the difelikefalin group were gastrointestinal (e.g., constipation and abdominal discomfort).
2 context sentences(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, phase 3 trial in Japan, patients with moderate to severe pruritus were randomly allocated 1:1 to receive either placebo or 0.5 μg/kg of difelikefalin three times per week intravenously for 6 weeks.
Summary · context
The primary end point was change from baseline in the Worst Itching Intensity Numerical Rating Scale (NRS; 0 to 10; higher scores indicate more severe itching) score at week 4.
Report a problemFND-3832052403
03HumanNon-randomized trialEfficacy outcome
In hemodialysis patients, prespecified secondary quality-of-life outcomes consistently improved with difelikefalin.
In plain wordsIn hemodialysis patients, quality-of-life outcomes consistently improved with difelikefalin.
Peptide
Difelikefalin
Outcome
Direction not reportedQuality of life
Study
n = 178
Analysis
Secondary
Outcome group
Quality of life · Whole body
Studied dose
0.5 μg/kg three times per week · intravenous · 6 weeksAs given in this study (human).
Source sentences
Summary
Prespecified secondary quality-of-life end points showed consistent improvement associated with difelikefalin.
2 context sentences(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, phase 3 trial in Japan, patients with moderate to severe pruritus were randomly allocated 1:1 to receive either placebo or 0.5 μg/kg of difelikefalin three times per week intravenously for 6 weeks.
Summary · context
The primary end point was change from baseline in the Worst Itching Intensity Numerical Rating Scale (NRS; 0 to 10; higher scores indicate more severe itching) score at week 4.
Report a problemFND-3832052402
04HumanNon-randomized trialSafety outcome
In hemodialysis patients, most treatment-related adverse events with difelikefalin were gastrointestinal.
In plain wordsIn hemodialysis patients, most treatment-related adverse events with difelikefalin affected the digestive system.
Peptide
Difelikefalin
Outcome
Direction not reportedGastrointestinal treatment-related adverse events
Study
n = 89
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 μg/kg three times per week · intravenous · 6 weeksAs given in this study (human).
Source sentences
Summary
The incidence of treatment-related adverse events in the placebo and difelikefalin groups was 3 of 89 patients (3%) and 13 of 89 patients (15%), respectively, of which the majority in the difelikefalin group were gastrointestinal (e.g., constipation and abdominal discomfort).
2 context sentences(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, phase 3 trial in Japan, patients with moderate to severe pruritus were randomly allocated 1:1 to receive either placebo or 0.5 μg/kg of difelikefalin three times per week intravenously for 6 weeks.
Summary · context
The primary end point was change from baseline in the Worst Itching Intensity Numerical Rating Scale (NRS; 0 to 10; higher scores indicate more severe itching) score at week 4.
Report a problemFND-3832052404

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

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