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Study · Randomized controlled trial · n = 851 · 2022

6 results

Efficacy of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis of KALM-1 and KALM-2 Phase 3 Studies.

Topf J, Wooldridge T, McCafferty K, Schömig M, Csiky B, Zwiech R, Wen W, Bhaduri S, Munera C, Lin R, Jebara A, Cirulli J, Menzaghi F

Kidney medicine28 Jun 2022Cited by 67 (Europe PMC)

PMID36016762 (opens in a new tab)PMCIDPMC9396406 (opens in a new tab)DOI10.1016/j.xkme.2022.100512 (opens in a new tab)PepBankPUB-36016762
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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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In hemodialysis patients, at least 3-point WI-NRS improvement occurred in 51.1% with difelikefalin versus 35.2% with placebo (P<0.001), with early week 1 efficacy.

    In plain wordsIn hemodialysis patients, at least 3-point itch improvement occurred in 51.1% with difelikefalin versus 35.2% with placebo.

    Peptide
    Difelikefalin
    Outcome
    IncreaseAt least 3-point WI-NRS response
    Study

    n = 851

    Comparator
    Placebo
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 mcg/kg three times/wk · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Achievement of ≥3-point WI-NRS reduction
    51.1%
    difelikefalin
    Achievement of ≥3-point WI-NRS reduction
    35.2%
    placebo
    P value
    < 0.001
    difelikefalin vs placebo

    Source sentences

    Summary
    This pooled analysis demonstrated early     (week 1), sustained difelikefalin efficacy, with significantly greater achievement of ≥3-point WI-NRS reduction with difelikefalin (51.1%) versus placebo (35.2%; P < 0.001).
    3 context sentences
    Summary · context
    In KALM-1 and KALM-2, participants were randomized (1:1) to receive intravenous difelikefalin or placebo 3 times/wk for 12 weeks, followed by a 52-week open-label extension.
    Summary · context
    Adults with moderate to severe CKD-aP treated by HD in North America, Europe, and the Asia-Pacific region.
    Summary · context
    Intravenous difelikefalin at 0.5 mcg/kg or placebo.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In hemodialysis patients, at least 4-point WI-NRS improvement occurred in 38.7% with difelikefalin versus 23.4% with placebo (P<0.001).

    In plain wordsIn hemodialysis patients, at least 4-point itch improvement occurred in 38.7% with difelikefalin versus 23.4% with placebo.

    Peptide
    Difelikefalin
    Outcome
    IncreaseAt least 4-point WI-NRS response
    Study

    n = 851

    Comparator
    Placebo
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 mcg/kg three times/wk · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Achievement of ≥4-point WI-NRS reduction
    38.7%
    difelikefalin
    Achievement of ≥4-point WI-NRS reduction
    23.4%
    placebo
    P value
    < 0.001
    difelikefalin vs placebo

    Source sentences

    Summary
    Achievement of a ≥4-point WI-NRS reduction was significantly greater with difelikefalin (38.7%) versus placebo (23.4%; P < 0.001).
    3 context sentences
    Summary · context
    In KALM-1 and KALM-2, participants were randomized (1:1) to receive intravenous difelikefalin or placebo 3 times/wk for 12 weeks, followed by a 52-week open-label extension.
    Summary · context
    Adults with moderate to severe CKD-aP treated by HD in North America, Europe, and the Asia-Pacific region.
    Summary · context
    Intravenous difelikefalin at 0.5 mcg/kg or placebo.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In hemodialysis patients, at least 15-point Skindex-10 improvement occurred in 55.5% with difelikefalin versus 40.5% with placebo (P<0.001).

    In plain wordsIn hemodialysis patients, at least 15-point Skindex-10 improvement occurred in 55.5% with difelikefalin versus 40.5% with placebo.

    Peptide
    Difelikefalin
    Outcome
    IncreaseAt least 15-point Skindex-10 response
    Study

    n = 851

    Comparator
    Placebo
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 mcg/kg three times/wk · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Achievement of ≥15-point Skindex-10 decrease
    55.5%
    difelikefalin
    Achievement of ≥15-point Skindex-10 decrease
    40.5%
    placebo
    P value
    < 0.001
    difelikefalin vs placebo

    Source sentences

    Summary
    More participants receiving difelikefalin versus placebo achieved clinically meaningful decreases of ≥15 points on the Skindex-10 scale (55.5% vs 40.5%, respectively; P P = 0.01), with sustained 5-D Itch effects up to 64 weeks.
    3 context sentences
    Summary · context
    In KALM-1 and KALM-2, participants were randomized (1:1) to receive intravenous difelikefalin or placebo 3 times/wk for 12 weeks, followed by a 52-week open-label extension.
    Summary · context
    Adults with moderate to severe CKD-aP treated by HD in North America, Europe, and the Asia-Pacific region.
    Summary · context
    Intravenous difelikefalin at 0.5 mcg/kg or placebo.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In hemodialysis patients, at least 5-point 5-D Itch improvement occurred in 52.1% with difelikefalin versus 42.3% with placebo (P=0.01).

    In plain wordsIn hemodialysis patients, at least 5-point 5-D Itch improvement occurred in 52.1% with difelikefalin versus 42.3% with placebo.

    Peptide
    Difelikefalin
    Outcome
    IncreaseAt least 5-point 5-D Itch response
    Study

    n = 851

    Comparator
    Placebo
    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 mcg/kg three times/wk · intravenous · 12 weeksAs given in this study (human).

    Measurements

    Achievement of ≥5-point 5-D Itch decrease
    52.1%
    difelikefalin
    Achievement of ≥5-point 5-D Itch decrease
    42.3%
    placebo
    P value
    0.01
    difelikefalin vs placebo

    Source sentences

    Summary
    More participants receiving difelikefalin versus placebo achieved clinically meaningful decreases of ≥15 points on the Skindex-10 scale (55.5% vs 40.5%, respectively; P P = 0.01), with sustained 5-D Itch effects up to 64 weeks.
    3 context sentences
    Summary · context
    In KALM-1 and KALM-2, participants were randomized (1:1) to receive intravenous difelikefalin or placebo 3 times/wk for 12 weeks, followed by a 52-week open-label extension.
    Summary · context
    Adults with moderate to severe CKD-aP treated by HD in North America, Europe, and the Asia-Pacific region.
    Summary · context
    Intravenous difelikefalin at 0.5 mcg/kg or placebo.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In hemodialysis patients, difelikefalin reduced itch across subgroups defined by age, sex, anti-itch medication, medical conditions, and gabapentin or pregabalin use.

    In plain wordsIn hemodialysis patients, difelikefalin reduced itch across demographic, medication, and medical-condition subgroups.

    Peptide
    Difelikefalin
    Outcome
    DecreaseItch intensity across clinical subgroups
    Study

    n: not reported in source

    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 mcg/kg three times/wk · intravenous · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Difelikefalin reduced itch intensity in subgroups based on age, sex, anti-itch medication use, the presence of specific medical conditions, and gabapentin or pregabalin use.
    3 context sentences
    Summary · context
    In KALM-1 and KALM-2, participants were randomized (1:1) to receive intravenous difelikefalin or placebo 3 times/wk for 12 weeks, followed by a 52-week open-label extension.
    Summary · context
    Adults with moderate to severe CKD-aP treated by HD in North America, Europe, and the Asia-Pacific region.
    Summary · context
    Intravenous difelikefalin at 0.5 mcg/kg or placebo.
  6. 06HumanNon-randomized trialEfficacy outcome

    In hemodialysis patients, difelikefalin effects on the 5-D Itch scale persisted up to 64 weeks.

    In plain wordsIn hemodialysis patients, difelikefalin effects on the 5-D Itch scale persisted up to 64 weeks.

    Peptide
    Difelikefalin
    Outcome
    DecreaseSustained 5-D Itch effect
    Study

    n: not reported in source

    Outcome group
    Skin and hair · Skin and wound
    Studied dose
    0.5 mcg/kg three times/wk · intravenous · up to 64 weeksAs given in this study (human).

    Source sentences

    Summary
    More participants receiving difelikefalin versus placebo achieved clinically meaningful decreases of ≥15 points on the Skindex-10 scale (55.5% vs 40.5%, respectively; P P = 0.01), with sustained 5-D Itch effects up to 64 weeks.
    3 context sentences
    Summary · context
    In KALM-1 and KALM-2, participants were randomized (1:1) to receive intravenous difelikefalin or placebo 3 times/wk for 12 weeks, followed by a 52-week open-label extension.
    Summary · context
    Adults with moderate to severe CKD-aP treated by HD in North America, Europe, and the Asia-Pacific region.
    Summary · context
    Intravenous difelikefalin at 0.5 mcg/kg or placebo.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03636269

CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Cara Therapeutics, Inc.n = 47317 Jul 2018 to 30 Mar 2020

Uremic Pruritus

Trial pageClinicalTrials.govUpdated 26 Apr 2022
CompletedPhase 3Results postedNCT03422653

A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)

Cara Therapeutics, Inc.n = 37820 Feb 2018 to 26 Mar 2020

Uremic Pruritus

Trial pageClinicalTrials.govUpdated 26 Apr 2022

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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