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Study · Randomized controlled trial · n = 249 · 2024

5 results

Difelikefalin in Black/African American Hemodialysis Patients with Moderate-to-Severe Pruritus: Post hoc Analysis of KALM-1 and KALM-2.

Fishbane S, Clegg DJ, Lerma EV, Rastogi A, Budden J, Morin I, Wen W, Menzaghi F, Topf J

American journal of nephrology22 Jan 2024Cited by 1 (Europe PMC)

PMID38253036 (opens in a new tab)PMCIDPMC11152003 (opens in a new tab)DOI10.1159/000534227 (opens in a new tab)PepBankPUB-38253036
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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 study5

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Black/AA haemodialysis patients, ≥3-point WI-NRS reduction occurred in 47.9% with difelikefalin versus 24.6% with placebo (p < 0.001).

    In plain wordsBlack/AA patients receiving difelikefalin more often achieved meaningful itch relief than those receiving placebo.

    Peptide
    Difelikefalin
    Outcome
    Increase≥3-point WI-NRS reduction in Black/AA patients
    Study

    n = 249

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 µg/kg · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Patients with >=3-point WI-NRS reduction
    47.9%
    Black/AA patients, difelikefalin 0.5 µg/kg
    Patients with >=3-point WI-NRS reduction
    24.6%
    Black/AA patients, placebo

    Source sentences

    Summary
    Clinically meaningful (≥3-point) reduction in WI-NRS score was achieved by 47.9% of Black/AA patients with difelikefalin versus 24.6% with placebo (p < 0.001).
    3 context sentences
    Summary · context
    This was a post hoc, pooled exploratory subgroup analysis of the Phase 3 KALM-1 and -2 studies.
    Summary · context
    Patients undergoing hemodialysis (HD) who had moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) at enrollment were stratified into self-reported Black/AA or White subgroups.
    Summary · context
    Patients were randomized (1:1) to receive intravenous (IV) difelikefalin 0.5 µg/kg or placebo for 12 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    Black/AA patients achieved ≥5-point 5-D itch improvement in 54.9% with difelikefalin versus 35.7% with placebo (p = 0.013).

    In plain wordsBlack/AA patients receiving difelikefalin more often improved their 5-D itch score than those receiving placebo.

    Peptide
    Difelikefalin
    Outcome
    Increase≥5-point 5-D itch improvement in Black/AA patients
    Study

    n = 249

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 µg/kg · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Patients with >=5-point 5-D itch total improvement
    54.9%
    Black/AA patients, difelikefalin 0.5 µg/kg
    Patients with >=5-point 5-D itch total improvement
    35.7%
    Black/AA patients, placebo

    Source sentences

    Summary
    More Black/AA patients achieved a ≥5-point 5-D itch total improvement (54.9% vs. 35.7%; p = 0.013) and a ≥15-point Skindex-10 score improvement with difelikefalin versus placebo (49.0% vs. 28.9%; p = 0.006) compared with White patients.
    3 context sentences
    Summary · context
    This was a post hoc, pooled exploratory subgroup analysis of the Phase 3 KALM-1 and -2 studies.
    Summary · context
    Patients undergoing hemodialysis (HD) who had moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) at enrollment were stratified into self-reported Black/AA or White subgroups.
    Summary · context
    Patients were randomized (1:1) to receive intravenous (IV) difelikefalin 0.5 µg/kg or placebo for 12 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    Black/AA patients achieved ≥15-point Skindex-10 improvement in 49.0% with difelikefalin versus 28.9% with placebo (p = 0.006).

    In plain wordsBlack/AA patients receiving difelikefalin more often improved itch-related quality of life than those receiving placebo.

    Peptide
    Difelikefalin
    Outcome
    Increase≥15-point Skindex-10 improvement in Black/AA patients
    Study

    n = 249

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.5 µg/kg · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Patients with >=15-point Skindex-10 improvement
    49%
    Black/AA patients, difelikefalin 0.5 µg/kg
    Patients with >=15-point Skindex-10 improvement
    28.9%
    Black/AA patients, placebo

    Source sentences

    Summary
    More Black/AA patients achieved a ≥5-point 5-D itch total improvement (54.9% vs. 35.7%; p = 0.013) and a ≥15-point Skindex-10 score improvement with difelikefalin versus placebo (49.0% vs. 28.9%; p = 0.006) compared with White patients.
    3 context sentences
    Summary · context
    This was a post hoc, pooled exploratory subgroup analysis of the Phase 3 KALM-1 and -2 studies.
    Summary · context
    Patients undergoing hemodialysis (HD) who had moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) at enrollment were stratified into self-reported Black/AA or White subgroups.
    Summary · context
    Patients were randomized (1:1) to receive intravenous (IV) difelikefalin 0.5 µg/kg or placebo for 12 weeks.
  4. 04HumanRandomized controlled trialSafety outcome

    In Black/AA patients, treatment-emergent adverse events occurred in 78.5% with difelikefalin versus 70.8% with placebo.

    In plain wordsBlack/AA patients receiving difelikefalin had more treatment-emergent adverse events than those receiving placebo.

    Peptide
    Difelikefalin
    Outcome
    IncreaseTEAEs in Black/AA patients
    Study

    n = 249

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 µg/kg · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Treatment-emergent adverse events incidence
    78.5%
    Black/AA patients, difelikefalin
    Treatment-emergent adverse events incidence
    70.8%
    Black/AA patients, placebo

    Source sentences

    Summary
    Incidence of treatment-emergent adverse events (TEAEs) was higher for Black/AA patients (difelikefalin: 78.5%; placebo: 70.8%) versus White patients (difelikefalin: 64.8%; placebo: 61.8%).
    3 context sentences
    Summary · context
    This was a post hoc, pooled exploratory subgroup analysis of the Phase 3 KALM-1 and -2 studies.
    Summary · context
    Patients undergoing hemodialysis (HD) who had moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) at enrollment were stratified into self-reported Black/AA or White subgroups.
    Summary · context
    Patients were randomized (1:1) to receive intravenous (IV) difelikefalin 0.5 µg/kg or placebo for 12 weeks.
  5. 05HumanRandomized controlled trialSafety outcome

    In White patients, treatment-emergent adverse events occurred in 64.8% with difelikefalin versus 61.8% with placebo.

    In plain wordsWhite patients receiving difelikefalin had more treatment-emergent adverse events than those receiving placebo.

    Peptide
    Difelikefalin
    Outcome
    IncreaseTEAEs in White patients
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Exploratory
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 µg/kg · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Treatment-emergent adverse events incidence
    64.8%
    White patients, difelikefalin
    Treatment-emergent adverse events incidence
    61.8%
    White patients, placebo

    Source sentences

    Summary
    Incidence of treatment-emergent adverse events (TEAEs) was higher for Black/AA patients (difelikefalin: 78.5%; placebo: 70.8%) versus White patients (difelikefalin: 64.8%; placebo: 61.8%).
    3 context sentences
    Summary · context
    This was a post hoc, pooled exploratory subgroup analysis of the Phase 3 KALM-1 and -2 studies.
    Summary · context
    Patients undergoing hemodialysis (HD) who had moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) at enrollment were stratified into self-reported Black/AA or White subgroups.
    Summary · context
    Patients were randomized (1:1) to receive intravenous (IV) difelikefalin 0.5 µg/kg or placebo for 12 weeks.

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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