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Study · Randomized controlled trial · 2023

14 results

A phase 2 study of oral difelikefalin in subjects with chronic kidney disease and moderate-to-severe pruritus.

Yosipovitch G, Awad A, Spencer RH, Munera C, Menzaghi F

Journal of the American Academy of Dermatology12 Apr 2023Cited by 25 (Europe PMC)

PMID37059302 (opens in a new tab)DOI10.1016/j.jaad.2023.03.051 (opens in a new tab)PepBankPUB-37059302
Publisher pagePubMedAsk about this study
Jump to 14 results

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 study14

14 results from studies that gave the peptide. 14 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In CKD patients with pruritus, difelikefalin 1.0 mg reduced WI-NRS scores versus placebo at week 12 (P = .018).

    In plain wordsDifelikefalin 1.0 mg reduced itching more than placebo in patients with kidney disease.

    Peptide
    Difelikefalin
    Outcome
    DecreaseWI-NRS change at 1.0 mg
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    1.0 mg once daily · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Difelikefalin 1.0 mg significantly reduced weekly mean WI-NRS scores versus placebo at week 12 (P = .018), with numerical reductions observed with difelikefalin 0.25 and 0.5 mg.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In CKD patients with pruritus, difelikefalin 0.25 mg showed numerical WI-NRS reductions versus placebo.

    In plain wordsDifelikefalin 0.25 mg showed numerically lower itch scores than placebo.

    Peptide
    Difelikefalin
    Outcome
    DecreaseWI-NRS change at 0.25 mg
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.25 mg once daily · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Difelikefalin 1.0 mg significantly reduced weekly mean WI-NRS scores versus placebo at week 12 (P = .018), with numerical reductions observed with difelikefalin 0.25 and 0.5 mg.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In CKD patients with pruritus, difelikefalin 0.5 mg showed numerical WI-NRS reductions versus placebo.

    In plain wordsDifelikefalin 0.5 mg showed numerically lower itch scores than placebo.

    Peptide
    Difelikefalin
    Outcome
    DecreaseWI-NRS change at 0.5 mg
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 mg once daily · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Difelikefalin 1.0 mg significantly reduced weekly mean WI-NRS scores versus placebo at week 12 (P = .018), with numerical reductions observed with difelikefalin 0.25 and 0.5 mg.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In CKD patients, complete response (WI-NRS 0-1) occurred in 38.6% with difelikefalin 1.0 mg versus 14.4% with placebo.

    In plain wordsDifelikefalin 1.0 mg produced complete itch responses more often than placebo.

    Peptide
    Difelikefalin
    Outcome
    IncreaseComplete itch response
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    1.0 mg once daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Complete response (WI-NRS 0-1) at week 12
    38.6%
    difelikefalin 1.0 mg
    Complete response (WI-NRS 0-1) at week 12
    14.4%
    placebo

    Source sentences

    Summary
    At week 12, 38.6% of subjects receiving difelikefalin 1.0 mg achieved a complete response (WI-NRS 0-1) versus 14.4% receiving placebo.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  5. 05HumanNon-randomized trialEfficacy outcome

    In CKD patients, difelikefalin produced approximately 20% improvement in itch-related quality-of-life measures.

    In plain wordsDifelikefalin improved itch-related quality of life by approximately 20% in patients with kidney disease.

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedItch-related quality of life
    Study

    n: not reported in source

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

    Measurements

    Improvement in itch-related quality-of-life measures
    ≈ 20%
    difelikefalin

    Source sentences

    Summary
    Difelikefalin resulted in ∼20% improvement in itch-related quality-of-life measures.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  6. 06HumanNon-randomized trialSafety outcome

    In CKD patients receiving difelikefalin, dizziness was among the most common treatment-emergent adverse events.

    In plain wordsDizziness was a common adverse event during difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableDizziness
    Study

    n: not reported in source

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common treatment-emergent adverse events were dizziness, fall, constipation, diarrhea, gastroesophageal reflux disease, fatigue, hyperkalemia, hypertension, and urinary tract infection.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  7. 07HumanNon-randomized trialSafety outcome

    In CKD patients receiving difelikefalin, falls were among the most common treatment-emergent adverse events.

    In plain wordsFalls were common adverse events during difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableFall
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common treatment-emergent adverse events were dizziness, fall, constipation, diarrhea, gastroesophageal reflux disease, fatigue, hyperkalemia, hypertension, and urinary tract infection.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  8. 08HumanNon-randomized trialSafety outcome

    In CKD patients receiving difelikefalin, constipation was among the most common treatment-emergent adverse events.

    In plain wordsConstipation was a common adverse event during difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableConstipation
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common treatment-emergent adverse events were dizziness, fall, constipation, diarrhea, gastroesophageal reflux disease, fatigue, hyperkalemia, hypertension, and urinary tract infection.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  9. 09HumanNon-randomized trialSafety outcome

    In CKD patients receiving difelikefalin, diarrhea was among the most common treatment-emergent adverse events.

    In plain wordsDiarrhea was a common adverse event during difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableDiarrhea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common treatment-emergent adverse events were dizziness, fall, constipation, diarrhea, gastroesophageal reflux disease, fatigue, hyperkalemia, hypertension, and urinary tract infection.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  10. 10HumanNon-randomized trialSafety outcome

    In CKD patients receiving difelikefalin, gastroesophageal reflux disease was among the most common treatment-emergent adverse events.

    In plain wordsAcid reflux was a common adverse event during difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableGastroesophageal reflux disease
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common treatment-emergent adverse events were dizziness, fall, constipation, diarrhea, gastroesophageal reflux disease, fatigue, hyperkalemia, hypertension, and urinary tract infection.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  11. 11HumanNon-randomized trialSafety outcome

    In CKD patients receiving difelikefalin, fatigue was among the most common treatment-emergent adverse events.

    In plain wordsFatigue was a common adverse event during difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableFatigue
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common treatment-emergent adverse events were dizziness, fall, constipation, diarrhea, gastroesophageal reflux disease, fatigue, hyperkalemia, hypertension, and urinary tract infection.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  12. 12HumanNon-randomized trialSafety outcome

    In CKD patients receiving difelikefalin, hyperkalemia was among the most common treatment-emergent adverse events.

    In plain wordsHigh potassium was a common adverse event during difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableHyperkalemia
    Study

    n: not reported in source

    Outcome group
    Adverse events · Kidney and urinary
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common treatment-emergent adverse events were dizziness, fall, constipation, diarrhea, gastroesophageal reflux disease, fatigue, hyperkalemia, hypertension, and urinary tract infection.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  13. 13HumanNon-randomized trialSafety outcome

    In CKD patients receiving difelikefalin, hypertension was among the most common treatment-emergent adverse events.

    In plain wordsHigh blood pressure was a common adverse event during difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableHypertension
    Study

    n: not reported in source

    Outcome group
    Adverse events · Cardiovascular
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common treatment-emergent adverse events were dizziness, fall, constipation, diarrhea, gastroesophageal reflux disease, fatigue, hyperkalemia, hypertension, and urinary tract infection.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily for 12 weeks.
  14. 14HumanNon-randomized trialSafety outcome

    In CKD patients receiving difelikefalin, urinary tract infection was among the most common treatment-emergent adverse events.

    In plain wordsUrinary tract infection was a common adverse event during difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableUrinary tract infection
    Study

    n: not reported in source

    Outcome group
    Adverse events · Infection
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common treatment-emergent adverse events were dizziness, fall, constipation, diarrhea, gastroesophageal reflux disease, fatigue, hyperkalemia, hypertension, and urinary tract infection.
    2 context sentences
    Summary · context
    This phase 2, double-blind, randomized, placebo-controlled, dose-finding study enrolled non-dialysis-dependent CKD (stage 3-5) and HD subjects with moderate-to-severe pruritus.
    Summary · context
    Subjects were equally randomized to oral difelikefalin (0.25, 0.5, or 1.0 mg) or placebo once daily 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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