Difelikefalin in Chinese patients with chronic kidney disease-associated pruritus.

Zuo L, Gan L, Guan T, He W, Ye H, Peng Q, Liu B, Dai H, Ba Y, Xue L, Lowe M, Enoiu M

Clinical kidney journal6 Feb 2026Cited by 1 (Europe PMC)

PMID41948117PMCIDPMC13053084DOI10.1093/ckj/sfag031PepBankPUB-41948117

Summary

BackgroundChronic kidney disease-associated pruritus (CKD-aP) is a common and debilitating condition in patients receiving in-centre haemodialysis. This study evaluated the efficacy and safety of difelikefalin (a new, intravenous treatment for moderate-to-severe CKD-aP approved in >40 countries) in a Chinese population receiving haemodialysis.MethodsThis Phase 3, multicentre, randomized placebo-controlled study included a 12-week double-blind treatment period, during which patients received either difelikefalin or placebo, followed by an optional 14-week open-label extension, in which all patients received difelikefalin. Endpoints included change from baseline in the Worst Itching Intensity Numerical Rating Scale (WI-NRS) at Week 4 (primary endpoint), the percentage of patients achieving a clinically relevant ≥3-point change in WI-NRS, patient-reported health-related quality-of-life measures, and incidence of adverse events.ResultsDifelikefalin-treated patients showed significantly greater improvements in least squares mean change from baseline in WI-NRS at Week 4 of the double-blind period compared with placebo [difelikefalin minus placebo: -0.81 (95% confidence interval: -1.25, -0.37); P = .0003], and patients with ≥3-point improvement in WI-NRS at Week 12 (48.7% versus 33.8%, nominal P = .0235). Difelikefalin also improved health-related quality of life, with clinically relevant changes observed in 5-D itch and Skindex-10 in most patients at Week 4 of the open-label extension (estimated ≥62% and ≥56%, respectively). Adverse events were mostly mild or moderate in severity and generally consistent with the known safety profile of difelikefalin.ConclusionDifelikefalin effectively reduced pruritus intensity and improved quality of life in Chinese patients with CKD-aP receiving haemodialysis, supporting its use in this population.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Chinese haemodialysis patients, difelikefalin reduced WI-NRS more than placebo at Week 4, with a difference of -0.81.
In plain wordsIn Chinese haemodialysis patients, difelikefalin reduced itch more than placebo at Week 4.
Peptide
Difelikefalin
Outcome
DecreaseWI-NRS change at Week 4
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Skin and hair · Skin and wound
Studied dose
Dose not stated · intravenousAs given in this study (human).
Measurements
WI-NRS difference
−0.81 points
difelikefalin minus placebo
95% CI lower
−1.25 points
WI-NRS difference
95% CI upper
−0.37 points
WI-NRS difference
P
0.0003
WI-NRS difference
Source sentences
Summary
Difelikefalin-treated patients showed significantly greater improvements in least squares mean change from baseline in WI-NRS at Week 4 of the double-blind period compared with placebo [difelikefalin minus placebo: -0.81 (95% confidence interval: -1.25, -0.37); P = .0003]
2 context sentences(design, population, supporting numbers)
Summary · context
This study evaluated the efficacy and safety of difelikefalin (a new, intravenous treatment for moderate-to-severe CKD-aP approved in >40 countries) in a Chinese population receiving haemodialysis.
Summary · context
This Phase 3, multicentre, randomized placebo-controlled study included a 12-week double-blind treatment period, during which patients received either difelikefalin or placebo, followed by an optional 14-week open-label extension, in which all patients received difelikefalin.
Show in the study text Report a problemFND-4194811701
02HumanRandomized controlled trialEfficacy outcome
In Chinese haemodialysis patients, ≥3-point WI-NRS improvement occurred in 48.7% with difelikefalin versus 33.8% with placebo at Week 12.
In plain wordsIn Chinese haemodialysis patients, more patients achieved itch improvement with difelikefalin than placebo.
Peptide
Difelikefalin
Outcome
IncreaseAt least 3-point WI-NRS improvement at Week 12
Study
n: not reported in source
Comparator
Placebo
Outcome group
Skin and hair · Skin and wound
Studied dose
Dose not stated · intravenousAs given in this study (human).
Measurements
Response
48.7%
difelikefalin; ≥3-point WI-NRS improvement
Response
33.8%
placebo; ≥3-point WI-NRS improvement
Nominal P
0.0235
Week 12 response comparison
Source sentences
Summary
and patients with ≥3-point improvement in WI-NRS at Week 12 (48.7% versus 33.8%, nominal P = .0235).
2 context sentences(design, population, supporting numbers)
Summary · context
This study evaluated the efficacy and safety of difelikefalin (a new, intravenous treatment for moderate-to-severe CKD-aP approved in >40 countries) in a Chinese population receiving haemodialysis.
Summary · context
This Phase 3, multicentre, randomized placebo-controlled study included a 12-week double-blind treatment period, during which patients received either difelikefalin or placebo, followed by an optional 14-week open-label extension, in which all patients received difelikefalin.
Show in the study text Report a problemFND-4194811702
03HumanNon-randomized trialEfficacy outcome
In Chinese haemodialysis patients receiving difelikefalin, an estimated ≥62% had clinically relevant 5-D itch improvements at extension Week 4.
In plain wordsIn Chinese haemodialysis patients, itch-related quality of life improved during the difelikefalin extension.
Peptide
Difelikefalin
Outcome
Direction not reported5-D itch improvement during extension
Study
n: not reported in source
Outcome group
Skin and hair · Skin and wound
Studied dose
Dose not stated · intravenousAs given in this study (human).
Measurements
5-D itch improvement
≥ 62%
extension Week 4
Source sentences
Summary
Difelikefalin also improved health-related quality of life, with clinically relevant changes observed in 5-D itch and Skindex-10 in most patients at Week 4 of the open-label extension (estimated ≥62% and ≥56%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
This study evaluated the efficacy and safety of difelikefalin (a new, intravenous treatment for moderate-to-severe CKD-aP approved in >40 countries) in a Chinese population receiving haemodialysis.
Summary · context
This Phase 3, multicentre, randomized placebo-controlled study included a 12-week double-blind treatment period, during which patients received either difelikefalin or placebo, followed by an optional 14-week open-label extension, in which all patients received difelikefalin.
Show in the study text Report a problemFND-4194811703
04HumanNon-randomized trialEfficacy outcome
In Chinese haemodialysis patients receiving difelikefalin, an estimated ≥56% had clinically relevant Skindex-10 improvements at extension Week 4.
In plain wordsIn Chinese haemodialysis patients, skin-related quality of life improved during the difelikefalin extension.
Peptide
Difelikefalin
Outcome
Direction not reportedSkindex-10 improvement during extension
Study
n: not reported in source
Outcome group
Skin and hair · Skin and wound
Studied dose
Dose not stated · intravenousAs given in this study (human).
Measurements
Skindex-10 improvement
≥ 56%
extension Week 4
Source sentences
Summary
Difelikefalin also improved health-related quality of life, with clinically relevant changes observed in 5-D itch and Skindex-10 in most patients at Week 4 of the open-label extension (estimated ≥62% and ≥56%, respectively).
2 context sentences(design, population, supporting numbers)
Summary · context
This study evaluated the efficacy and safety of difelikefalin (a new, intravenous treatment for moderate-to-severe CKD-aP approved in >40 countries) in a Chinese population receiving haemodialysis.
Summary · context
This Phase 3, multicentre, randomized placebo-controlled study included a 12-week double-blind treatment period, during which patients received either difelikefalin or placebo, followed by an optional 14-week open-label extension, in which all patients received difelikefalin.
Show in the study text Report a problemFND-4194811704
05HumanNon-randomized trialSafety outcome
In Chinese haemodialysis patients receiving difelikefalin, adverse events were mostly mild or moderate.
In plain wordsIn Chinese haemodialysis patients receiving difelikefalin, most adverse events were mild or moderate.
Peptide
Difelikefalin
Outcome
Not applicableAdverse event severity
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · intravenousAs given in this study (human).
Source sentences
Summary
Adverse events were mostly mild or moderate in severity and generally consistent with the known safety profile of difelikefalin.
2 context sentences(design, population, supporting numbers)
Summary · context
This study evaluated the efficacy and safety of difelikefalin (a new, intravenous treatment for moderate-to-severe CKD-aP approved in >40 countries) in a Chinese population receiving haemodialysis.
Summary · context
This Phase 3, multicentre, randomized placebo-controlled study included a 12-week double-blind treatment period, during which patients received either difelikefalin or placebo, followed by an optional 14-week open-label extension, in which all patients received difelikefalin.
Show in the study text Report a problemFND-4194811705

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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Keywords

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