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Study · Observational study · n = 438 · 2025

7 results

Real-world safety of difelikefalin for chronic kidney disease-associated pruritus: initial insights from a European managed access programme.

Latus J, Mayer G, Narvaez C, Manu M, Jesus S, Ruessmann D, Manenti L

Clinical kidney journal24 Sept 2025

PMID41133182 (opens in a new tab)PMCIDPMC12541368 (opens in a new tab)DOI10.1093/ckj/sfaf297 (opens in a new tab)PepBankPUB-41133182
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Summary

BackgroundChronic kidney disease-associated pruritus (CKD-aP) is a debilitating condition with limited treatment options. A managed access programme (MAP) began in October 2021 to provide early, controlled access to the novel antipruritic difelikefalin to European and Australian patients with CKD-aP with no local access to commercially available treatments. Here, we describe the safety data collected up to 31 October 2024.MethodsEligible adults with moderate-to-severe CKD-aP receiving in-centre haemodialysis (HD) were provided with difelikefalin (0.5 µg/kg) intravenously after each HD session. All adverse events (AEs) were recorded; a Global Drug Safety team assessed seriousness and causality. AE details, including outcomes, were also recorded.ResultsA total of 438 patients were provided with a median of 115 (min-max: 30-1035) days of difelikefalin treatment. Of these, 167 (38.1%) patients experienced 458 AEs. Of 246 serious AEs (SAEs), 10.2% were considered possibly related to difelikefalin. Of those with a known outcome, 88.0% were resolved during the MAP. There were 63 fatal SAEs, none considered related to difelikefalin. There were 152 non-serious AEs, of which 63.8% were deemed possibly/probably related to difelikefalin. Of the 59 difelikefalin-related non-serious AEs with a known outcome, 86.4% were resolved during the MAP. Most AEs and SAEs were consistent with conditions typical of patients with CKD requiring HD and/or the known safety profile of difelikefalin.ConclusionsNo new safety signals were detected in this MAP analysis over a 3-year period. The overall safety results were consistent with the known safety profile for difelikefalin patients with moderate-to-severe CKD-aP receiving HD.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanObservational studySafety outcome

    Among difelikefalin recipients, 167 (38.1%) patients experienced 458 adverse events.

    In plain wordsAmong difelikefalin recipients, 38.1% experienced adverse events.

    Peptide
    Difelikefalin
    Outcome
    Not applicableAdverse events
    Study

    n = 438

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 µg/kg after each HD session · intravenous · median 115 days (min-max 30-1035)As given in this study (human).

    Measurements

    Patients with adverse events
    167 patients
    of 438 treated
    Patients with adverse events
    38.1%
    of 438 treated
    Adverse events
    458 events
    all patients

    Source sentences

    Summary
    Of these, 167 (38.1%) patients experienced 458 AEs.
    2 context sentences
    Summary · context
    A total of 438 patients were provided with a median of 115 (min-max: 30-1035) days of difelikefalin treatment.
    Summary · context
    Eligible adults with moderate-to-severe CKD-aP receiving in-centre haemodialysis (HD) were provided with difelikefalin (0.5 µg/kg) intravenously after each HD session.
  2. 02HumanObservational studySafety outcome

    Among difelikefalin recipients, 246 serious adverse events occurred, with 10.2% considered possibly related to difelikefalin.

    In plain wordsAmong difelikefalin recipients, 10.2% of serious adverse events were considered possibly related to treatment.

    Peptide
    Difelikefalin
    Outcome
    Not applicableSerious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 µg/kg after each HD session · intravenous · median 115 days (min-max 30-1035)As given in this study (human).

    Measurements

    Serious adverse events
    246 events
    all patients
    Serious adverse events possibly related to difelikefalin
    10.2%
    of 246 SAEs

    Source sentences

    Summary
    Of 246 serious AEs (SAEs), 10.2% were considered possibly related to difelikefalin.
    1 context sentence
    Summary · context
    Eligible adults with moderate-to-severe CKD-aP receiving in-centre haemodialysis (HD) were provided with difelikefalin (0.5 µg/kg) intravenously after each HD session.
  3. 03HumanObservational studySafety outcome

    Among difelikefalin recipients, 88.0% of serious adverse events with a known outcome resolved during the programme.

    In plain wordsAmong difelikefalin recipients, 88.0% of serious adverse events with known outcomes resolved.

    Peptide
    Difelikefalin
    Outcome
    Not applicableSerious adverse event resolution
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 µg/kg after each HD session · intravenous · median 115 days (min-max 30-1035)As given in this study (human).

    Measurements

    Serious adverse events resolved during the programme
    88%
    those with a known outcome

    Source sentences

    Summary
    Of those with a known outcome, 88.0% were resolved during the MAP.
    2 context sentences
    Summary · context
    Of 246 serious AEs (SAEs), 10.2% were considered possibly related to difelikefalin.
    Summary · context
    Eligible adults with moderate-to-severe CKD-aP receiving in-centre haemodialysis (HD) were provided with difelikefalin (0.5 µg/kg) intravenously after each HD session.
  4. 04HumanObservational studySafety outcome

    Among difelikefalin recipients, 63 fatal serious adverse events occurred, none considered related to difelikefalin.

    In plain wordsDifelikefalin recipients had 63 fatal serious adverse events, none considered treatment-related.

    Peptide
    Difelikefalin
    Outcome
    Not applicableFatal serious adverse events
    Study

    n: not reported in source

    Outcome group
    Mortality · Whole body
    Studied dose
    0.5 µg/kg after each HD session · intravenous · median 115 days (min-max 30-1035)As given in this study (human).

    Measurements

    Fatal serious adverse events
    63 events
    all patients

    Source sentences

    Summary
    There were 63 fatal SAEs, none considered related to difelikefalin.
    1 context sentence
    Summary · context
    Eligible adults with moderate-to-severe CKD-aP receiving in-centre haemodialysis (HD) were provided with difelikefalin (0.5 µg/kg) intravenously after each HD session.
  5. 05HumanObservational studySafety outcome

    Among difelikefalin recipients, 152 non-serious adverse events occurred, with 63.8% deemed possibly or probably related to difelikefalin.

    In plain wordsAmong difelikefalin recipients, 63.8% of non-serious adverse events were deemed possibly or probably treatment-related.

    Peptide
    Difelikefalin
    Outcome
    Not applicableNon-serious adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 µg/kg after each HD session · intravenous · median 115 days (min-max 30-1035)As given in this study (human).

    Measurements

    Non-serious adverse events
    152 events
    all patients
    Non-serious adverse events possibly/probably related to difelikefalin
    63.8%
    of 152 non-serious AEs

    Source sentences

    Summary
    There were 152 non-serious AEs, of which 63.8% were deemed possibly/probably related to difelikefalin.
    1 context sentence
    Summary · context
    Eligible adults with moderate-to-severe CKD-aP receiving in-centre haemodialysis (HD) were provided with difelikefalin (0.5 µg/kg) intravenously after each HD session.
  6. 06HumanObservational studySafety outcome

    Of 59 difelikefalin-related non-serious adverse events with a known outcome, 86.4% resolved during the programme.

    In plain wordsAmong difelikefalin-related non-serious adverse events with known outcomes, 86.4% resolved.

    Peptide
    Difelikefalin
    Outcome
    Not applicableRelated non-serious adverse event resolution
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 µg/kg after each HD session · intravenous · median 115 days (min-max 30-1035)As given in this study (human).

    Measurements

    Difelikefalin-related non-serious adverse events with known outcome
    59 events
    related non-serious AEs
    Related non-serious adverse events resolved during the programme
    86.4%
    of 59 with known outcome

    Source sentences

    Summary
    Of the 59 difelikefalin-related non-serious AEs with a known outcome, 86.4% were resolved during the MAP.
    1 context sentence
    Summary · context
    Eligible adults with moderate-to-severe CKD-aP receiving in-centre haemodialysis (HD) were provided with difelikefalin (0.5 µg/kg) intravenously after each HD session.
  7. 07HumanObservational studySafety outcome

    In haemodialysis patients receiving difelikefalin, most adverse events matched typical conditions or the known safety profile.

    In plain wordsMost adverse events in difelikefalin recipients matched typical dialysis conditions or the known drug safety profile.

    Peptide
    Difelikefalin
    Outcome
    Not applicableAdverse event profile
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.5 µg/kg after each HD session · intravenous · median 115 days (min-max 30-1035)As given in this study (human).

    Source sentences

    Summary
    Most AEs and SAEs were consistent with conditions typical of patients with CKD requiring HD and/or the known safety profile of difelikefalin.
    1 context sentence
    Summary · context
    Eligible adults with moderate-to-severe CKD-aP receiving in-centre haemodialysis (HD) were provided with difelikefalin (0.5 µg/kg) intravenously after each HD session.

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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