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Study · Non-randomized trial · n = 222 · 2022

11 results

Safety and Effectiveness of Difelikefalin in Patients With Moderate-to-Severe Pruritus Undergoing Hemodialysis: An Open-Label, Multicenter Study.

Weiner DE, Vervloet MG, Walpen S, Schaufler T, Munera C, Menzaghi F, Wen W, Bhaduri S, Germain MJ

Kidney medicine24 Aug 2022Cited by 17 (Europe PMC)

PMID36185706 (opens in a new tab)PMCIDPMC9516453 (opens in a new tab)DOI10.1016/j.xkme.2022.100542 (opens in a new tab)PepBankPUB-36185706
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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 study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In hemodialysis patients, treatment-related adverse events with difelikefalin occurred in 16 participants (7.2%).

    In plain wordsIn hemodialysis patients, treatment-related adverse events with difelikefalin occurred in 16 participants (7.2%).

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedTreatment-related treatment-emergent adverse events
    Study

    n = 222

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 μg/kg after each hemodialysis session · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Participants with treatment-related TEAEs
    16 participants
    difelikefalin, single arm
    Participants with treatment-related TEAEs
    7.2%
    difelikefalin, single arm

    Source sentences

    Summary
    Treatment-related treatment-emergent adverse events were reported in 16 participants (7.2%); those most commonly reported were somnolence (1.8%), hypoesthesia (1.4%), nausea (0.9%), and dizziness (0.9%).
    3 context sentences
    Summary · context
    Open-label, multicenter, single-arm intervention trial.
    Summary · context
    Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.
    Summary · context
    Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.
  2. 02HumanNon-randomized trialSafety outcome

    In hemodialysis patients, treatment-related somnolence occurred in 1.8% with difelikefalin.

    In plain wordsIn hemodialysis patients, treatment-related sleepiness occurred in 1.8% with difelikefalin.

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedSomnolence
    Study

    n = 222

    Analysis
    Primary
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    0.5 μg/kg after each hemodialysis session · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Treatment-related somnolence
    1.8%
    difelikefalin, single arm

    Source sentences

    Summary
    Treatment-related treatment-emergent adverse events were reported in 16 participants (7.2%); those most commonly reported were somnolence (1.8%), hypoesthesia (1.4%), nausea (0.9%), and dizziness (0.9%).
    3 context sentences
    Summary · context
    Open-label, multicenter, single-arm intervention trial.
    Summary · context
    Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.
    Summary · context
    Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.
  3. 03HumanNon-randomized trialSafety outcome

    In hemodialysis patients, treatment-related hypoesthesia occurred in 1.4% with difelikefalin.

    In plain wordsIn hemodialysis patients, treatment-related reduced sensation occurred in 1.4% with difelikefalin.

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedHypoesthesia
    Study

    n = 222

    Analysis
    Primary
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    0.5 μg/kg after each hemodialysis session · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Treatment-related hypoesthesia
    1.4%
    difelikefalin, single arm

    Source sentences

    Summary
    Treatment-related treatment-emergent adverse events were reported in 16 participants (7.2%); those most commonly reported were somnolence (1.8%), hypoesthesia (1.4%), nausea (0.9%), and dizziness (0.9%).
    3 context sentences
    Summary · context
    Open-label, multicenter, single-arm intervention trial.
    Summary · context
    Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.
    Summary · context
    Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.
  4. 04HumanNon-randomized trialSafety outcome

    In hemodialysis patients, treatment-related nausea occurred in 0.9% with difelikefalin.

    In plain wordsIn hemodialysis patients, treatment-related nausea occurred in 0.9% with difelikefalin.

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedNausea
    Study

    n = 222

    Analysis
    Primary
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.5 μg/kg after each hemodialysis session · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Treatment-related nausea
    0.9%
    difelikefalin, single arm

    Source sentences

    Summary
    Treatment-related treatment-emergent adverse events were reported in 16 participants (7.2%); those most commonly reported were somnolence (1.8%), hypoesthesia (1.4%), nausea (0.9%), and dizziness (0.9%).
    3 context sentences
    Summary · context
    Open-label, multicenter, single-arm intervention trial.
    Summary · context
    Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.
    Summary · context
    Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.
  5. 05HumanNon-randomized trialSafety outcome

    In hemodialysis patients, treatment-related dizziness occurred in 0.9% with difelikefalin.

    In plain wordsIn hemodialysis patients, treatment-related dizziness occurred in 0.9% with difelikefalin.

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedDizziness
    Study

    n = 222

    Analysis
    Primary
    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    0.5 μg/kg after each hemodialysis session · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Treatment-related dizziness
    0.9%
    difelikefalin, single arm

    Source sentences

    Summary
    Treatment-related treatment-emergent adverse events were reported in 16 participants (7.2%); those most commonly reported were somnolence (1.8%), hypoesthesia (1.4%), nausea (0.9%), and dizziness (0.9%).
    3 context sentences
    Summary · context
    Open-label, multicenter, single-arm intervention trial.
    Summary · context
    Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.
    Summary · context
    Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.
  6. 06HumanNon-randomized trialSafety outcome

    In hemodialysis patients receiving difelikefalin, no deaths were considered treatment-related.

    In plain wordsIn hemodialysis patients receiving difelikefalin, no deaths were considered treatment-related.

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedTreatment-related deaths
    Study

    n = 222

    Analysis
    Primary
    Outcome group
    Mortality · Whole body
    Studied dose
    0.5 μg/kg after each hemodialysis session · intravenous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No deaths or serious treatment-emergent adverse events were considered treatment-related.
    3 context sentences
    Summary · context
    Open-label, multicenter, single-arm intervention trial.
    Summary · context
    Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.
    Summary · context
    Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.
  7. 07HumanNon-randomized trialSafety outcome

    In hemodialysis patients receiving difelikefalin, no serious treatment-emergent adverse events were considered treatment-related.

    In plain wordsIn hemodialysis patients receiving difelikefalin, no serious adverse events were considered treatment-related.

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedTreatment-related serious adverse events
    Study

    n = 222

    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 μg/kg after each hemodialysis session · intravenous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    No deaths or serious treatment-emergent adverse events were considered treatment-related.
    3 context sentences
    Summary · context
    Open-label, multicenter, single-arm intervention trial.
    Summary · context
    Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.
    Summary · context
    Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.
  8. 08HumanNon-randomized trialEfficacy outcome

    In hemodialysis patients receiving difelikefalin, 74% reported at least 3-point improvement in itch intensity.

    In plain wordsIn hemodialysis patients receiving difelikefalin, 74% reported at least 3-point improvement in itch intensity.

    Peptide
    Difelikefalin
    Outcome
    DecreaseAt least 3-point WI-NRS improvement
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 μg/kg after each hemodialysis session · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Participants with clinically meaningful itch reduction
    74%
    difelikefalin, single arm, at least 3-point improvement

    Source sentences

    Summary
    Clinically meaningful reduction in itch intensity (≥3-point improvement) was reported by 74% of participants, with 70% and 63% also reporting a clinically relevant improvement in QoL as measured by 5-D itch and Skindex-10.
    3 context sentences
    Summary · context
    Open-label, multicenter, single-arm intervention trial.
    Summary · context
    Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.
    Summary · context
    Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.
  9. 09HumanNon-randomized trialEfficacy outcome

    In hemodialysis patients receiving difelikefalin, 70% reported clinically relevant quality-of-life improvement on the 5-D itch scale.

    In plain wordsIn hemodialysis patients receiving difelikefalin, 70% reported clinically relevant improvement on the 5-D itch scale.

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedClinically relevant 5-D itch improvement
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 μg/kg after each hemodialysis session · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Participants with clinically relevant 5-D itch improvement
    70%
    difelikefalin, single arm

    Source sentences

    Summary
    Clinically meaningful reduction in itch intensity (≥3-point improvement) was reported by 74% of participants, with 70% and 63% also reporting a clinically relevant improvement in QoL as measured by 5-D itch and Skindex-10.
    3 context sentences
    Summary · context
    Open-label, multicenter, single-arm intervention trial.
    Summary · context
    Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.
    Summary · context
    Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.
  10. 10HumanNon-randomized trialEfficacy outcome

    In hemodialysis patients receiving difelikefalin, 63% reported clinically relevant quality-of-life improvement on Skindex-10.

    In plain wordsIn hemodialysis patients receiving difelikefalin, 63% reported clinically relevant improvement on Skindex-10.

    Peptide
    Difelikefalin
    Outcome
    Direction not reportedClinically relevant Skindex-10 improvement
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 μg/kg after each hemodialysis session · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Participants with clinically relevant Skindex-10 improvement
    63%
    difelikefalin, single arm

    Source sentences

    Summary
    Clinically meaningful reduction in itch intensity (≥3-point improvement) was reported by 74% of participants, with 70% and 63% also reporting a clinically relevant improvement in QoL as measured by 5-D itch and Skindex-10.
    3 context sentences
    Summary · context
    Open-label, multicenter, single-arm intervention trial.
    Summary · context
    Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.
    Summary · context
    Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.
  11. 11HumanNon-randomized trialEfficacy outcome

    In hemodialysis patients receiving difelikefalin, 66% reported sleep quality improvement of at least 3 points.

    In plain wordsIn hemodialysis patients receiving difelikefalin, 66% reported sleep quality improvement of at least 3 points.

    Peptide
    Difelikefalin
    Outcome
    DecreaseAt least 3-point sleep quality score reduction
    Study

    n: not reported in source

    Analysis
    Secondary
    Outcome group
    Sleep · Sleep
    Studied dose
    0.5 μg/kg after each hemodialysis session · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Participants with sleep quality improvement
    66%
    difelikefalin, single arm, at least 3-point reduction on Numerical Rating Scale

    Source sentences

    Summary
    Sleep quality improvement (≥3-point reduction on the Numerical Rating Scale) was reported in 66% of participants.
    3 context sentences
    Summary · context
    Open-label, multicenter, single-arm intervention trial.
    Summary · context
    Maintenance hemodialysis patients with moderate-to-severe CKD-aP at enrollment.
    Summary · context
    Intravenous difelikefalin 0.5 μg/kg after each hemodialysis session for 12 weeks.

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 pageClinicalTrials.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.

  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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