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.

Fotheringham J, Guest J, Latus J, Lerma E, Morin I, Schaufler T, Soro M, Ständer S, Zeig S

The patient9 Jan 2024Cited by 12 (Europe PMC)

PMID38196014PMCIDPMC10894140DOI10.1007/s40271-023-00668-1PepBankPUB-38196014

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

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanNon-randomized trialEfficacy outcome
In difelikefalin-treated haemodialysis patients, EQ-5D-5L utility increased by 0.04 from baseline to 12 weeks (p = 0.001).
In plain wordsWith difelikefalin, patients reported better overall health utility than at baseline.
Peptide
Difelikefalin
Outcome
IncreaseEQ-5D-5L utility
Study
n = 197
Outcome group
Quality of life · Whole body
Studied dose
Dose not stated · intravenous · 12 weeksAs given in this study (human).
Measurements
EQ-5D-5L mean utility change from baseline
0.04 utility score
difelikefalin, baseline to 12 weeks
Source sentences
Summary
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.
1 context sentence(design, population, supporting numbers)
Summary · context
Post 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, Skind…
Report a problemFND-3819601406
02HumanNon-randomized trialEfficacy outcome
In difelikefalin-treated haemodialysis patients, EQ-5D visual analogue scores increased by 2.8 from baseline to 12 weeks (p = 0.046).
In plain wordsWith difelikefalin, patients reported higher overall health scores than at baseline.
Peptide
Difelikefalin
Outcome
IncreaseEQ-5D visual analogue score
Study
n = 197
Outcome group
Quality of life · Whole body
Studied dose
Dose not stated · intravenous · 12 weeksAs given in this study (human).
Measurements
EQ-5D visual analogue scale mean change from baseline
2.8 points
difelikefalin, baseline to 12 weeks
Source sentences
Summary
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.
1 context sentence(design, population, supporting numbers)
Summary · context
Post 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, Skind…
Report a problemFND-3819601407
03HumanNon-randomized trialEfficacy outcome
In haemodialysis patients receiving difelikefalin, 73.7% achieved a ≥3-point WI-NRS reduction at 12 weeks.
In plain wordsWith difelikefalin, 73.7% of patients reported a meaningful decrease in itching from baseline.
Peptide
Difelikefalin
Outcome
DecreaseWI-NRS response
Study
n: not reported in source
Outcome group
Skin and hair · Skin and wound
Studied dose
Dose not stated · intravenous · 12 weeksAs given in this study (human).
Measurements
Patients with ≥3-point WI-NRS reduction
73.7%
baseline to 12 weeks
Source sentences
Summary
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.
1 context sentence(design, population, supporting numbers)
Summary · context
Post 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, Skind…
Report a problemFND-3819601401
04HumanNon-randomized trialEfficacy outcome
In haemodialysis patients receiving difelikefalin, 66% experienced ≥3-point SQ-NRS improvements at 12 weeks.
In plain wordsWith difelikefalin, 66% of patients reported meaningful sleep improvements from baseline.
Peptide
Difelikefalin
Outcome
Direction not reportedSQ-NRS response
Study
n: not reported in source
Outcome group
Sleep · Sleep
Studied dose
Dose not stated · intravenous · 12 weeksAs given in this study (human).
Measurements
Patients with ≥3-point SQ-NRS improvement
66%
baseline to 12 weeks
Source sentences
Summary
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.
1 context sentence(design, population, supporting numbers)
Summary · context
Post 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, Skind…
Report a problemFND-3819601402
05HumanNon-randomized trialEfficacy outcome
In haemodialysis patients receiving difelikefalin, all Skindex-10 domain scores improved from baseline.
In plain wordsWith difelikefalin, patients reported improvements in all Skindex-10 domains from baseline.
Peptide
Difelikefalin
Outcome
Direction not reportedSkindex-10 domain scores
Study
n: not reported in source
Outcome group
Quality of life · Whole body
Studied dose
Dose not stated · intravenous · 12 weeksAs given in this study (human).
Source sentences
Summary
Improvements were also observed in all Skindex-10 scale and 5-D itch scale domain scores.
1 context sentence(design, population, supporting numbers)
Summary · context
Post 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, Skind…
Report a problemFND-3819601403
06HumanNon-randomized trialEfficacy outcome
In haemodialysis patients receiving difelikefalin, all 5-D itch domain scores improved from baseline.
In plain wordsWith difelikefalin, patients reported improvements in all 5-D itch domains from baseline.
Peptide
Difelikefalin
Outcome
Direction not reported5-D itch domain scores
Study
n: not reported in source
Outcome group
Skin and hair · Skin and wound
Studied dose
Dose not stated · intravenous · 12 weeksAs given in this study (human).
Source sentences
Summary
Improvements were also observed in all Skindex-10 scale and 5-D itch scale domain scores.
1 context sentence(design, population, supporting numbers)
Summary · context
Post 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, Skind…
Report a problemFND-3819601404
07HumanNon-randomized trialEfficacy outcome
In difelikefalin-treated haemodialysis patients, the proportion reporting no EQ-PSO problems increased from 1.4 to 24.7% (p < 0.001).
In plain wordsWith difelikefalin, more patients reported no quality-of-life problems than at baseline.
Peptide
Difelikefalin
Outcome
IncreaseNo problems in all EQ-PSO domains
Study
n: not reported in source
Outcome group
Quality of life · Whole body
Studied dose
Dose not stated · intravenous · 12 weeksAs given in this study (human).
Measurements
Patients reporting no problems in all EQ-PSO domains
1.4%
baseline
Patients reporting no problems in all EQ-PSO domains
24.7%
12 weeks
p value
< 0.001
1.4% to 24.7%
Source sentences
Summary
The percentage of patients reporting no problems in all EQ-PSO domains increased from 1.4 to 24.7% (p < 0.001), respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Post 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, Skind…
Report a problemFND-3819601405

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03998163

CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Cara Therapeutics, Inc.n = 2226 May 2019 to 6 Mar 2020

Uremic Pruritus

Trial page ClinicalTrials.govUpdated 15 Oct 2021

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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