Skip to content

Study · Observational study · n = 20 · 2026

11 results

Real-world effectiveness and tolerability of difelikefalin over 12 months for hemodialysis-associated pruritus.

Di Giovanni M, Piccinni CP, Tagliente F, Urciuolo F, Fulignati P, Bonerba B, Pesce F, Grandaliano G

International urology and nephrology23 Dec 2025Cited by 1 (Europe PMC)

PMID41436718 (opens in a new tab)DOI10.1007/s11255-025-04957-6 (opens in a new tab)PepBankPUB-41436718
Publisher pagePubMedAsk about this study
Jump to 11 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: Publisher copyright. Results still quote short attributed sentences.

Results from this study11

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

  1. 01HumanObservational studyOther

    Twelve hemodialysis patients (60%) completed 12 months of difelikefalin treatment.

    In plain wordsTwelve hemodialysis patients (60%) completed 12 months of difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableTreatment completion
    Study

    n = 20

    Outcome group
    Treatment adherence and retention · Whole body
    Studied dose
    0.5 mcg/kg after each HD session · intravenous · up to 12 monthsAs given in this study (human).

    Measurements

    Completion
    12 patients
    12 months
    Completion proportion
    60%
    12 months

    Source sentences

    Summary
    Twelve patients (60%) completed 12 months of treatment.
    2 context sentences
    Summary · context
    This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP.
    Summary · context
    Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months.
  2. 02HumanObservational studySafety outcome

    Eight hemodialysis patients (40%) discontinued difelikefalin treatment.

    In plain wordsEight hemodialysis patients (40%) discontinued difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableDiscontinuation
    Study

    n = 20

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 mcg/kg after each HD session · intravenous · up to 12 monthsAs given in this study (human).

    Measurements

    Discontinuations
    8 patients
    all causes
    Discontinuation proportion
    40%
    all causes

    Source sentences

    Summary
    Discontinuation (n = 8, 40%) was due to adverse events (n = 3, 15%; primarily diarrhoea, mild cognitive impairment), mortality (n = 3, 15%; unrelated cardiovascular events), and patient refusal (n = 2, 10%).
    2 context sentences
    Summary · context
    This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP.
    Summary · context
    Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months.
  3. 03HumanObservational studySafety outcome

    Three hemodialysis patients (15%) discontinued difelikefalin because of adverse events, primarily diarrhoea and mild cognitive impairment.

    In plain wordsThree hemodialysis patients (15%) stopped difelikefalin because of adverse events, primarily diarrhoea and mild cognitive impairment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableDiscontinuation due to adverse events
    Study

    n = 20

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 mcg/kg after each HD session · intravenous · up to 12 monthsAs given in this study (human).

    Measurements

    Adverse-event discontinuations
    3 patients
    difelikefalin
    Adverse-event discontinuations
    15%
    difelikefalin

    Source sentences

    Summary
    Discontinuation (n = 8, 40%) was due to adverse events (n = 3, 15%; primarily diarrhoea, mild cognitive impairment), mortality (n = 3, 15%; unrelated cardiovascular events), and patient refusal (n = 2, 10%).
    2 context sentences
    Summary · context
    This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP.
    Summary · context
    Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months.
  4. 04HumanObservational studySafety outcome

    Three hemodialysis patients (15%) died from unrelated cardiovascular events during difelikefalin treatment.

    In plain wordsThree hemodialysis patients (15%) died from unrelated cardiovascular events during difelikefalin treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableMortality
    Study

    n = 20

    Outcome group
    Mortality · Cardiovascular
    Studied dose
    0.5 mcg/kg after each HD session · intravenous · up to 12 monthsAs given in this study (human).

    Measurements

    Deaths
    3 patients
    unrelated cardiovascular events
    Mortality
    15%
    unrelated cardiovascular events

    Source sentences

    Summary
    Discontinuation (n = 8, 40%) was due to adverse events (n = 3, 15%; primarily diarrhoea, mild cognitive impairment), mortality (n = 3, 15%; unrelated cardiovascular events), and patient refusal (n = 2, 10%).
    2 context sentences
    Summary · context
    This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP.
    Summary · context
    Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months.
  5. 05HumanObservational studyOther

    Two hemodialysis patients (10%) discontinued difelikefalin because of patient refusal.

    In plain wordsTwo hemodialysis patients (10%) discontinued difelikefalin because of patient refusal.

    Peptide
    Difelikefalin
    Outcome
    Not applicableDiscontinuation due to refusal
    Study

    n = 20

    Outcome group
    Treatment adherence and retention · Whole body
    Studied dose
    0.5 mcg/kg after each HD session · intravenous · up to 12 monthsAs given in this study (human).

    Measurements

    Refusal discontinuations
    2 patients
    difelikefalin
    Refusal discontinuations
    10%
    difelikefalin

    Source sentences

    Summary
    Discontinuation (n = 8, 40%) was due to adverse events (n = 3, 15%; primarily diarrhoea, mild cognitive impairment), mortality (n = 3, 15%; unrelated cardiovascular events), and patient refusal (n = 2, 10%).
    2 context sentences
    Summary · context
    This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP.
    Summary · context
    Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months.
  6. 06HumanObservational studyEfficacy outcome

    In hemodialysis patients, difelikefalin treatment was linked to WI-NRS reduction from 8.00 to 3.92 at 12 months (p = 0.0001).

    In plain wordsIn hemodialysis patients, difelikefalin treatment was linked to reduced itching compared with baseline.

    Peptide
    Difelikefalin
    Outcome
    DecreaseWI-NRS at 12 months
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Pruritus · Skin and wound
    Studied dose
    0.5 mcg/kg after each HD session · intravenous · up to 12 monthsAs given in this study (human).

    Measurements

    WI-NRS
    8 score
    baseline
    WI-NRS
    3.92 score
    T12

    Source sentences

    Summary
    A significant reduction in WI-NRS scores was observed from baseline (mean 8.00) to T12 (mean 3.92; p = 0.0001).
    2 context sentences
    Summary · context
    This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP.
    Summary · context
    Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months.
  7. 07HumanObservational studyEfficacy outcome

    In hemodialysis patients, difelikefalin treatment was linked to PSDS reduction from 2.90 to 1.17 at 12 months (p = 0.002).

    In plain wordsIn hemodialysis patients, difelikefalin treatment was linked to reduced itch-related sleep disturbance compared with baseline.

    Peptide
    Difelikefalin
    Outcome
    DecreaseSleep disturbance at 12 months
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Sleep · Sleep
    Studied dose
    0.5 mcg/kg after each HD session · intravenous · up to 12 monthsAs given in this study (human).

    Measurements

    PSDS
    2.9 score
    baseline
    PSDS
    1.17 score
    T12

    Source sentences

    Summary
    PSDS scores also significantly improved from baseline (mean 2.90) to T12 (mean 1.17; p = 0.002).
    2 context sentences
    Summary · context
    This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP.
    Summary · context
    Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months.
  8. 08HumanObservational studyEfficacy outcome

    In hemodialysis patients receiving difelikefalin, SF-12 physical component scores did not change significantly.

    In plain wordsIn hemodialysis patients receiving difelikefalin, physical quality of life scores did not change significantly compared with baseline.

    Peptide
    Difelikefalin
    Outcome
    No significant changeSF-12 physical component
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.5 mcg/kg after each HD session · intravenous · up to 12 monthsAs given in this study (human).

    Source sentences

    Summary
    No significant changes were observed in SF-12 physical or mental component scores.
    2 context sentences
    Summary · context
    This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP.
    Summary · context
    Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months.
  9. 09HumanObservational studyEfficacy outcome

    In hemodialysis patients receiving difelikefalin, SF-12 mental component scores did not change significantly.

    In plain wordsIn hemodialysis patients receiving difelikefalin, mental quality of life scores did not change significantly compared with baseline.

    Peptide
    Difelikefalin
    Outcome
    No significant changeSF-12 mental component
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Quality of life · Mental health and mood
    Studied dose
    0.5 mcg/kg after each HD session · intravenous · up to 12 monthsAs given in this study (human).

    Source sentences

    Summary
    No significant changes were observed in SF-12 physical or mental component scores.
    2 context sentences
    Summary · context
    This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP.
    Summary · context
    Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months.
  10. 10HumanObservational studySafety outcome

    In hemodialysis patients receiving difelikefalin, diarrhoea was among the primary adverse events leading to discontinuation.

    In plain wordsIn hemodialysis patients receiving difelikefalin, diarrhoea was among the main adverse events that led to treatment cessation.

    Peptide
    Difelikefalin
    Outcome
    Not applicableDiarrhoea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.5 mcg/kg after each HD session · intravenous · up to 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Discontinuation (n = 8, 40%) was due to adverse events (n = 3, 15%; primarily diarrhoea, mild cognitive impairment), mortality (n = 3, 15%; unrelated cardiovascular events), and patient refusal (n = 2, 10%).
    2 context sentences
    Summary · context
    This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP.
    Summary · context
    Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months.
  11. 11HumanObservational studySafety outcome

    In hemodialysis patients receiving difelikefalin, mild cognitive impairment was among the primary adverse events leading to discontinuation.

    In plain wordsIn hemodialysis patients receiving difelikefalin, mild cognitive impairment was among the main adverse events that led to treatment cessation.

    Peptide
    Difelikefalin
    Outcome
    Not applicableMild cognitive impairment
    Study

    n: not reported in source

    Outcome group
    Adverse events · Nervous system and cognition
    Studied dose
    0.5 mcg/kg after each HD session · intravenous · up to 12 monthsAs given in this study (human).

    Source sentences

    Summary
    Discontinuation (n = 8, 40%) was due to adverse events (n = 3, 15%; primarily diarrhoea, mild cognitive impairment), mortality (n = 3, 15%; unrelated cardiovascular events), and patient refusal (n = 2, 10%).
    2 context sentences
    Summary · context
    This retrospective observational study included 20 HD patients with moderate-to-severe, refractory CKD-aP.
    Summary · context
    Patients received intravenous Difelikefalin (0.5 mcg/kg) after each HD session for up to 12 months.

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.

PepBank is a research reference. Talk to a doctor before you use any peptide.