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Study · Non-randomized trial · 2024

6 results

Chronic kidney disease-associated pruritus and quality of life with difelikefalin treatment: a post hoc analysis of phase 3 data using the Skindex-10 questionnaire.

Ständer S, Fishbane S, Schaufler T, Ruessmann D, Morin I, Menzaghi F, Wen W, Kalantar-Zadeh K

Clinical kidney journal6 Sept 2024Cited by 4 (Europe PMC)

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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In haemodialysis patients, difelikefalin improved Skindex-10 total scores versus placebo (difference -3.4, 95% CI -5.5, -1.3, P = .002).

    In plain wordsDifelikefalin was linked to greater improvement in itch-related quality of life than placebo.

    Outcome
    DecreaseSkindex-10 total score versus placebo
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Measurements

    LS mean treatment difference in Skindex-10 total score
    −3.4 points
    difelikefalin versus placebo, Week 12
    95% CI of LS mean treatment difference in Skindex-10 total score
    −5.5 to −1.3 points
    difelikefalin versus placebo, Week 12

    Source sentences

    Summary
    Patients receiving difelikefalin had greater improvements in Skindex-10 total scores than those receiving placebo [LS mean treatment difference -3.4; 95% confidence interval (CI) -5.5, -1.3; P = .002] and greater improvements across Skindex-10 domains (disease, mood and social functioning) at Week 12.
  2. 02HumanNon-randomized trialEfficacy outcome

    In haemodialysis patients, difelikefalin was linked to greater improvement in the Skindex-10 disease domain than placebo.

    In plain wordsDifelikefalin was linked to greater improvement in the disease domain than placebo.

    Outcome
    Direction not reportedSkindex-10 disease domain versus placebo
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Patients receiving difelikefalin had greater improvements in Skindex-10 total scores than those receiving placebo [LS mean treatment difference -3.4; 95% confidence interval (CI) -5.5, -1.3; P = .002] and greater improvements across Skindex-10 domains (disease, mood and social functioning) at Week 12.
  3. 03HumanNon-randomized trialEfficacy outcome

    In haemodialysis patients, difelikefalin was linked to greater improvement in the Skindex-10 mood domain than placebo.

    In plain wordsDifelikefalin was linked to greater improvement in the mood domain than placebo.

    Outcome
    Direction not reportedSkindex-10 mood domain versus placebo
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Patients receiving difelikefalin had greater improvements in Skindex-10 total scores than those receiving placebo [LS mean treatment difference -3.4; 95% confidence interval (CI) -5.5, -1.3; P = .002] and greater improvements across Skindex-10 domains (disease, mood and social functioning) at Week 12.
  4. 04HumanNon-randomized trialEfficacy outcome

    In haemodialysis patients, difelikefalin was linked to greater improvement in Skindex-10 social functioning than placebo.

    In plain wordsDifelikefalin was linked to greater improvement in social functioning than placebo.

    Outcome
    Direction not reportedSkindex-10 social functioning versus placebo
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Patients receiving difelikefalin had greater improvements in Skindex-10 total scores than those receiving placebo [LS mean treatment difference -3.4; 95% confidence interval (CI) -5.5, -1.3; P = .002] and greater improvements across Skindex-10 domains (disease, mood and social functioning) at Week 12.
  5. 05HumanObservational studyEfficacy outcome

    Difelikefalin recipients with ≥3-point itch improvement had greater Skindex-10 improvement than lesser responders (difference 14.2, 95% CI 11.0, 17.3, P < .001).

    In plain wordsAmong difelikefalin recipients, greater itch improvement was linked to greater quality-of-life improvement than lesser itch improvement.

    Outcome
    Direction not reportedSkindex-10 total score by itch response
    Study

    n: not reported in source

    Comparator
    <3-point WI-NRS reduction
    Outcome group
    Quality of life · Whole body
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Measurements

    Mean difference in Skindex-10 total score improvement
    14.2 points
    difelikefalin recipients with >=3-point WI-NRS reduction versus <3-point reduction, Week 12
    95% CI of mean difference in Skindex-10 total score improvement
    11 to 17.3 points
    difelikefalin recipients with >=3-point WI-NRS reduction versus <3-point reduction, Week 12

    Source sentences

    Summary
    In patients receiving difelikefalin, those with clinically meaningful improvements in pruritus (≥3-point reduction in WI-NRS score) at Week 12 had a greater improvement in Skindex-10 total score (mean difference 14.2; 95% CI 11.0, 17.3; P < .001) and Skindex-10 domains than those with a <3-po…
  6. 06HumanObservational studyEfficacy outcome

    Difelikefalin recipients with ≥3-point WI-NRS reduction had greater Skindex-10 domain improvements than those with <3-point reduction.

    In plain wordsAmong difelikefalin recipients, greater itch improvement was linked to greater improvement across quality-of-life domains than lesser itch improvement.

    Outcome
    Direction not reportedSkindex-10 domains by itch response
    Study

    n: not reported in source

    Comparator
    <3-point WI-NRS reduction
    Outcome group
    Quality of life · Whole body
    Studied dose
    Dose not stated · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    In patients receiving difelikefalin, those with clinically meaningful improvements in pruritus (≥3-point reduction in WI-NRS score) at Week 12 had a greater improvement in Skindex-10 total score (mean difference 14.2; 95% CI 11.0, 17.3; P < .001) and Skindex-10 domains than those with a <3-po…

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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