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Study · Randomized controlled trial · n = 174 · 2020

10 results

Randomized Controlled Trial of Difelikefalin for Chronic Pruritus in Hemodialysis Patients.

Fishbane S, Mathur V, Germain MJ, Shirazian S, Bhaduri S, Munera C, Spencer RH, Menzaghi F

Kidney international reports28 Jan 2020Cited by 75 (Europe PMC)

PMID32405581 (opens in a new tab)PMCIDPMC7210745 (opens in a new tab)DOI10.1016/j.ekir.2020.01.006 (opens in a new tab)PepBankPUB-32405581
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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-ND. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In hemodialysis patients, pooled difelikefalin doses reduced itch intensity more than placebo at week 8 (P = 0.002).

    In plain wordsIn hemodialysis patients, difelikefalin reduced itching more than placebo.

    Peptide
    Difelikefalin
    Outcome
    DecreaseItch intensity
    Study

    n = 174

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Pruritus · Skin and wound
    Studied dose
    0.5, 1.0, or 1.5 μg/kg thrice weekly · intravenous · 8 weeksAs given in this study (human).

    Measurements

    P value for all difelikefalin doses combined versus placebo
    0.002
    change in itch intensity score from baseline at week 8

    Source sentences

    Summary
    A significant reduction from baseline in itch intensity scores at week 8 favored all difelikefalin doses combined versus placebo (P = 0.002).
    1 context sentence
    Summary · context
    In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 μg/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In hemodialysis patients, difelikefalin improved Skindex-10 scores versus placebo (P ≤ 0.005).

    In plain wordsIn hemodialysis patients, difelikefalin improved itch-related quality of life on Skindex-10 more than placebo.

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedSkindex-10 score
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Quality of life · Skin and wound
    Studied dose
    0.5, 1.0, or 1.5 μg/kg thrice weekly · intravenous · 8 weeksAs given in this study (human).

    Measurements

    P value for difelikefalin versus placebo
    ≤ 0.005
    Skindex-10 score

    Source sentences

    Summary
    Difelikefalin also showed improvement over placebo in Skindex-10, 5-D itch, and sleep disturbance scores (P ≤ 0.005).
    1 context sentence
    Summary · context
    In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 μg/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In hemodialysis patients, difelikefalin improved 5-D itch scores versus placebo (P ≤ 0.005).

    In plain wordsIn hemodialysis patients, difelikefalin improved itch scores more than placebo.

    Peptide
    Difelikefalin
    Outcome
    Direction not reported5-D itch score
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Pruritus · Skin and wound
    Studied dose
    0.5, 1.0, or 1.5 μg/kg thrice weekly · intravenous · 8 weeksAs given in this study (human).

    Measurements

    P value for difelikefalin versus placebo
    ≤ 0.005
    5-D itch score

    Source sentences

    Summary
    Difelikefalin also showed improvement over placebo in Skindex-10, 5-D itch, and sleep disturbance scores (P ≤ 0.005).
    1 context sentence
    Summary · context
    In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 μg/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In hemodialysis patients, difelikefalin improved sleep disturbance scores versus placebo (P ≤ 0.005).

    In plain wordsIn hemodialysis patients, difelikefalin improved sleep disturbance more than placebo.

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedSleep disturbance score
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Sleep · Sleep
    Studied dose
    0.5, 1.0, or 1.5 μg/kg thrice weekly · intravenous · 8 weeksAs given in this study (human).

    Source sentences

    Summary
    Difelikefalin also showed improvement over placebo in Skindex-10, 5-D itch, and sleep disturbance scores (P ≤ 0.005).
    1 context sentence
    Summary · context
    In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 μg/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial.
  5. 05HumanRandomized controlled trialSafety outcome

    In hemodialysis patients, treatment-emergent adverse events occurred in 78% with difelikefalin versus 42% with placebo.

    In plain wordsIn hemodialysis patients, adverse events occurred more often with difelikefalin than placebo.

    Peptide
    Difelikefalin
    Outcome
    IncreaseTreatment-emergent adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5, 1.0, or 1.5 μg/kg thrice weekly · intravenous · 8 weeksAs given in this study (human).

    Measurements

    Treatment-emergent adverse events
    78%
    difelikefalin
    Treatment-emergent adverse events
    42%
    placebo

    Source sentences

    Summary
    Overall, 78% of patients receiving difelikefalin reported treatment-emergent adverse events versus 42% of patients given placebo, with diarrhea, dizziness, nausea, somnolence, and fall being the most frequent (≥5%).
    1 context sentence
    Summary · context
    In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 μg/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial.
  6. 06HumanNon-randomized trialSafety outcome

    In hemodialysis patients receiving difelikefalin, diarrhea was among the most frequent adverse events (≥5%).

    In plain wordsIn hemodialysis patients receiving difelikefalin, diarrhea was among the most frequent adverse events.

    Peptide
    Difelikefalin
    Outcome
    Not applicableDiarrhea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.5, 1.0, or 1.5 μg/kg thrice weekly · intravenous · 8 weeksAs given in this study (human).

    Measurements

    Diarrhea frequency threshold
    ≥ 5%
    among the most frequent adverse events

    Source sentences

    Summary
    Overall, 78% of patients receiving difelikefalin reported treatment-emergent adverse events versus 42% of patients given placebo, with diarrhea, dizziness, nausea, somnolence, and fall being the most frequent (≥5%).
    1 context sentence
    Summary · context
    In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 μg/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial.
  7. 07HumanNon-randomized trialSafety outcome

    In hemodialysis patients receiving difelikefalin, dizziness was among the most frequent adverse events (≥5%).

    In plain wordsIn hemodialysis patients receiving difelikefalin, dizziness was among the most frequent adverse events.

    Peptide
    Difelikefalin
    Outcome
    Not applicableDizziness
    Study

    n: not reported in source

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    0.5, 1.0, or 1.5 μg/kg thrice weekly · intravenous · 8 weeksAs given in this study (human).

    Measurements

    Dizziness frequency threshold
    ≥ 5%
    among the most frequent adverse events

    Source sentences

    Summary
    Overall, 78% of patients receiving difelikefalin reported treatment-emergent adverse events versus 42% of patients given placebo, with diarrhea, dizziness, nausea, somnolence, and fall being the most frequent (≥5%).
    1 context sentence
    Summary · context
    In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 μg/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial.
  8. 08HumanNon-randomized trialSafety outcome

    In hemodialysis patients receiving difelikefalin, nausea was among the most frequent adverse events (≥5%).

    In plain wordsIn hemodialysis patients receiving difelikefalin, nausea was among the most frequent adverse events.

    Peptide
    Difelikefalin
    Outcome
    Not applicableNausea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.5, 1.0, or 1.5 μg/kg thrice weekly · intravenous · 8 weeksAs given in this study (human).

    Measurements

    Nausea frequency threshold
    ≥ 5%
    among the most frequent adverse events

    Source sentences

    Summary
    Overall, 78% of patients receiving difelikefalin reported treatment-emergent adverse events versus 42% of patients given placebo, with diarrhea, dizziness, nausea, somnolence, and fall being the most frequent (≥5%).
    1 context sentence
    Summary · context
    In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 μg/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial.
  9. 09HumanNon-randomized trialSafety outcome

    In hemodialysis patients receiving difelikefalin, somnolence was among the most frequent adverse events (≥5%).

    In plain wordsIn hemodialysis patients receiving difelikefalin, sleepiness was among the most frequent adverse events.

    Peptide
    Difelikefalin
    Outcome
    Not applicableSomnolence
    Study

    n: not reported in source

    Outcome group
    Adverse events · Sleep
    Studied dose
    0.5, 1.0, or 1.5 μg/kg thrice weekly · intravenous · 8 weeksAs given in this study (human).

    Measurements

    Somnolence frequency threshold
    ≥ 5%
    among the most frequent adverse events

    Source sentences

    Summary
    Overall, 78% of patients receiving difelikefalin reported treatment-emergent adverse events versus 42% of patients given placebo, with diarrhea, dizziness, nausea, somnolence, and fall being the most frequent (≥5%).
    1 context sentence
    Summary · context
    In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 μg/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial.
  10. 10HumanNon-randomized trialSafety outcome

    In hemodialysis patients receiving difelikefalin, fall was among the most frequent adverse events (≥5%).

    In plain wordsIn hemodialysis patients receiving difelikefalin, falls were among the most frequent adverse events.

    Peptide
    Difelikefalin
    Outcome
    Not applicableFall
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5, 1.0, or 1.5 μg/kg thrice weekly · intravenous · 8 weeksAs given in this study (human).

    Measurements

    Fall frequency threshold
    ≥ 5%
    among the most frequent adverse events

    Source sentences

    Summary
    Overall, 78% of patients receiving difelikefalin reported treatment-emergent adverse events versus 42% of patients given placebo, with diarrhea, dizziness, nausea, somnolence, and fall being the most frequent (≥5%).
    1 context sentence
    Summary · context
    In this study, 174 hemodialysis patients with moderate-to-severe pruritus were randomly assigned to receive difelikefalin (0.5, 1.0, or 1.5 μg/kg) or placebo intravenously thrice weekly after each hemodialysis session for 8 weeks in a double-blind, controlled trial.

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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