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

Aucella F, Zerbi S, Monaco MP, Bonomini M, Alberici F, Losappio V, Stallone G, Tagliente F, Urciuolo F, Grandaliano G, Aucella F, Nardella M, Manenti L

Clinical kidney journal18 Feb 2025Cited by 1 (Europe PMC)

PMID40989995PMCIDPMC12451441DOI10.1093/ckj/sfaf050PepBankPUB-40989995

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Summary

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Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanObservational studySafety outcome
Among patients receiving difelikefalin, one stopped treatment for dizziness.
In plain wordsOne patient receiving difelikefalin stopped treatment because of dizziness.
Peptide
Difelikefalin
Outcome
Not applicableDiscontinuation for dizziness
Study
n = 20
Outcome group
Adverse events · Nervous system and cognition
Studied dose
weight-based dosing at the end of each dialysis session · intravenousAs given in this study (human).
Measurements
Patients stopping treatment for dizziness
1 patients
of 20 treated
Source sentences
Summary
Eighteen of 20 patients were treated for 12 weeks; 2 patients stopped treatment for dizziness (n = 1) and discomfort (n = 1).
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
DFK was administered intravenously with weight-based dosing at the end of each dialysis session.
Report a problemFND-4098999501
02HumanObservational studySafety outcome
Among patients receiving difelikefalin, one stopped treatment for discomfort.
In plain wordsOne patient receiving difelikefalin stopped treatment because of discomfort.
Peptide
Difelikefalin
Outcome
Not applicableDiscontinuation for discomfort
Study
n = 20
Outcome group
Adverse events · Whole body
Studied dose
weight-based dosing at the end of each dialysis session · intravenousAs given in this study (human).
Measurements
Patients stopping treatment for discomfort
1 patients
of 20 treated
Source sentences
Summary
Eighteen of 20 patients were treated for 12 weeks; 2 patients stopped treatment for dizziness (n = 1) and discomfort (n = 1).
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
DFK was administered intravenously with weight-based dosing at the end of each dialysis session.
Report a problemFND-4098999502
03HumanObservational studyEfficacy outcome
In haemodialysis patients receiving difelikefalin, WI-NRS improved by more than 3 in 11/18 (61%) at Week 4.
In plain wordsDifelikefalin treatment was linked to improved itching scores in 61% of patients at Week 4.
Peptide
Difelikefalin
Outcome
Direction not reportedWI-NRS improvement at Week 4
Study
n = 18
Outcome group
Skin and hair · Skin and wound
Studied dose
weight-based dosing at the end of each dialysis session · intravenous · 4 weeksAs given in this study (human).
Measurements
Patients with WI-NRS improvement >3
11 patients
Week 4; of 18
Patients with WI-NRS improvement >3
61%
Week 4; 11/18
Source sentences
Summary
WI-NRS score improved >3 in 11/18 (61%) at Week 4 and in 16/18 (88%) at Week 12.
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
DFK was administered intravenously with weight-based dosing at the end of each dialysis session.
Report a problemFND-4098999503
04HumanObservational studyEfficacy outcome
In haemodialysis patients receiving difelikefalin, WI-NRS improved by more than 3 in 16/18 (88%) at Week 12.
In plain wordsDifelikefalin treatment was linked to improved itching scores in 88% of patients at Week 12.
Peptide
Difelikefalin
Outcome
Direction not reportedWI-NRS improvement at Week 12
Study
n = 18
Outcome group
Skin and hair · Skin and wound
Studied dose
weight-based dosing at the end of each dialysis session · intravenous · 12 weeksAs given in this study (human).
Measurements
Patients with WI-NRS improvement >3
16 patients
Week 12; of 18
Patients with WI-NRS improvement >3
88%
Week 12; 16/18
Source sentences
Summary
WI-NRS score improved >3 in 11/18 (61%) at Week 4 and in 16/18 (88%) at Week 12.
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
DFK was administered intravenously with weight-based dosing at the end of each dialysis session.
Report a problemFND-4098999504
05HumanObservational studyEfficacy outcome
In haemodialysis patients receiving difelikefalin, scratching lesions disappeared in 12/15 (80%).
In plain wordsDifelikefalin treatment was linked to disappearance of scratching lesions in 80% of affected patients.
Peptide
Difelikefalin
Outcome
DecreaseScratching lesion disappearance
Study
n = 15
Outcome group
Skin and hair · Skin and wound
Studied dose
weight-based dosing at the end of each dialysis session · intravenousAs given in this study (human).
Measurements
Patients with scratching lesions that disappeared
12 patients
of 15 with lesions
Patients with scratching lesions that disappeared
80%
12/15
Source sentences
Summary
5D-ITCH decreased from basal 18.6 to 10.5 at Week 12, while sleep quality at the same time points changed from 2.6 to 5.8; scratching lesions disappeared in 12/15 (80%).
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
DFK was administered intravenously with weight-based dosing at the end of each dialysis session.
Report a problemFND-4098999507
06HumanObservational studyEfficacy outcome
In haemodialysis patients receiving difelikefalin, 5D-ITCH decreased from 18.6 to 10.5 at Week 12.
In plain wordsDifelikefalin treatment was linked to a lower 5D-ITCH score at Week 12.
Peptide
Difelikefalin
Outcome
Decrease5D-ITCH score
Study
n: not reported in source
Outcome group
Skin and hair · Skin and wound
Studied dose
weight-based dosing at the end of each dialysis session · intravenous · 12 weeksAs given in this study (human).
Measurements
5D-ITCH score
18.6 points
basal
5D-ITCH score
10.5 points
Week 12
Source sentences
Summary
5D-ITCH decreased from basal 18.6 to 10.5 at Week 12, while sleep quality at the same time points changed from 2.6 to 5.8; scratching lesions disappeared in 12/15 (80%).
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
DFK was administered intravenously with weight-based dosing at the end of each dialysis session.
Report a problemFND-4098999505
07HumanObservational studyEfficacy outcome
In haemodialysis patients receiving difelikefalin, sleep quality scores changed from 2.6 to 5.8 at Week 12.
In plain wordsDifelikefalin treatment was linked to a sleep quality score change from 2.6 to 5.8.
Peptide
Difelikefalin
Outcome
IncreaseSleep quality
Study
n: not reported in source
Outcome group
Sleep · Sleep
Studied dose
weight-based dosing at the end of each dialysis session · intravenous · 12 weeksAs given in this study (human).
Measurements
Sleep quality score
2.6 points
basal time point
Sleep quality score
5.8 points
Week 12
Source sentences
Summary
5D-ITCH decreased from basal 18.6 to 10.5 at Week 12, while sleep quality at the same time points changed from 2.6 to 5.8; scratching lesions disappeared in 12/15 (80%).
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
DFK was administered intravenously with weight-based dosing at the end of each dialysis session.
Report a problemFND-4098999506
08HumanObservational studySafety outcome
In haemodialysis patients receiving difelikefalin, no other side effects were reported beyond the two early therapy breaks.
In plain wordsNo other side effects were reported with difelikefalin beyond those responsible for the two early treatment stops.
Peptide
Difelikefalin
Outcome
Not applicableOther side effects
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
weight-based dosing at the end of each dialysis session · intravenousAs given in this study (human).
Source sentences
Summary
Except for the two early therapy breaks, no other side effects were reported.
2 context sentences(design, population, supporting numbers)
Summary · context
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.
Summary · context
DFK was administered intravenously with weight-based dosing at the end of each dialysis session.
Report a problemFND-4098999508

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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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