A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus.

Fishbane S, Jamal A, Munera C, Wen W, Menzaghi F

The New England journal of medicine8 Nov 2019Cited by 267 (Europe PMC)

PMID31702883DOI10.1056/nejmoa1912770PepBankPUB-31702883

Publisher page PubMedAsk about this study

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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In hemodialysis patients with pruritus, observed response was 82/158 (51.9%) with difelikefalin versus 51/165 (30.9%) with placebo.
In plain wordsIn hemodialysis patients, difelikefalin produced more itch responses than placebo.
Peptide
Difelikefalin
Outcome
IncreaseObserved WI-NRS response of at least 3 points
Study
n = 323
Comparator
Placebo
Analysis
Primary
Outcome group
Pruritus · Skin and wound
Studied dose
0.5 μg/kg three times per week · intravenous · 12 weeksAs given in this study (human).
Measurements
Patients with WI-NRS decrease of at least 3 points
82 patients
difelikefalin group, observed, of 158
Patients with WI-NRS decrease of at least 3 points
51.9%
difelikefalin group, observed
Patients with WI-NRS decrease of at least 3 points
51 patients
placebo group, observed, of 165
Patients with WI-NRS decrease of at least 3 points
30.9%
placebo group, observed
Source sentences
Summary
A total of 82 of 158 patients (51.9%) in the difelikefalin group had a decrease of at least 3 points in the WI-NRS score (primary outcome), as compared with 51 of 165 (30.9%) in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks.
Report a problemFND-3170288301
02HumanRandomized controlled trialEfficacy outcome
In hemodialysis patients, imputed itch response was 49.1% with difelikefalin versus 27.9% with placebo (P<0.001).
In plain wordsIn hemodialysis patients, difelikefalin improved itch response more than placebo.
Peptide
Difelikefalin
Outcome
IncreaseImputed WI-NRS response of at least 3 points
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Pruritus · Skin and wound
Studied dose
0.5 μg/kg three times per week · intravenous · 12 weeksAs given in this study (human).
Measurements
Imputed percentage with WI-NRS decrease of at least 3 points
49.1%
difelikefalin group
Imputed percentage with WI-NRS decrease of at least 3 points
27.9%
placebo group
P value for difelikefalin versus placebo
< 0.001
imputed WI-NRS response of at least 3 points
Source sentences
Summary
The imputed percentage of patients with a decrease of at least 3 points in the WI-NRS score was 49.1% in the difelikefalin group, as compared with 27.9% in the placebo group (P<0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks.
Report a problemFND-3170288302
03HumanRandomized controlled trialEfficacy outcome
In hemodialysis patients, imputed response was 37.1% with difelikefalin versus 17.9% with placebo, with observed responders 64/158 versus 35/165 (P<0.001).
In plain wordsIn hemodialysis patients, difelikefalin produced more large itch improvements than placebo.
Peptide
Difelikefalin
Outcome
IncreaseWI-NRS response of at least 4 points
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Pruritus · Skin and wound
Studied dose
0.5 μg/kg three times per week · intravenous · 12 weeksAs given in this study (human).
Measurements
Imputed percentage with WI-NRS decrease of at least 4 points
37.1%
difelikefalin group
Imputed percentage with WI-NRS decrease of at least 4 points
17.9%
placebo group
Observed patients with WI-NRS decrease of at least 4 points
64 patients
difelikefalin group, of 158
Observed patients with WI-NRS decrease of at least 4 points
35 patients
placebo group, of 165
P value for difelikefalin versus placebo
< 0.001
WI-NRS decrease of at least 4 points
Source sentences
Summary
The imputed percentage of patients with a decrease of at least 4 points in the WI-NRS score at week 12 was significantly greater in the difelikefalin group than in the placebo group (37.1% [observed data: 64 of 158 patients] vs. 17.9% [observed data: 35 of 165 patients], P<0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks.
Report a problemFND-3170288305
04HumanRandomized controlled trialSafety outcome
In hemodialysis patients, diarrhea was more common with difelikefalin than placebo.
In plain wordsIn hemodialysis patients, diarrhea occurred more often with difelikefalin than placebo.
Peptide
Difelikefalin
Outcome
IncreaseDiarrhea
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 μg/kg three times per week · intravenous · 12 weeksAs given in this study (human).
Source sentences
Summary
Diarrhea, dizziness, and vomiting were more common in the difelikefalin group than in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks.
Report a problemFND-3170288306
05HumanRandomized controlled trialSafety outcome
In hemodialysis patients, dizziness was more common with difelikefalin than placebo.
In plain wordsIn hemodialysis patients, dizziness occurred more often with difelikefalin than placebo.
Peptide
Difelikefalin
Outcome
IncreaseDizziness
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Adverse events · Nervous system and cognition
Studied dose
0.5 μg/kg three times per week · intravenous · 12 weeksAs given in this study (human).
Source sentences
Summary
Diarrhea, dizziness, and vomiting were more common in the difelikefalin group than in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks.
Report a problemFND-3170288307
06HumanRandomized controlled trialSafety outcome
In hemodialysis patients, vomiting was more common with difelikefalin than placebo.
In plain wordsIn hemodialysis patients, vomiting occurred more often with difelikefalin than placebo.
Peptide
Difelikefalin
Outcome
IncreaseVomiting
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 μg/kg three times per week · intravenous · 12 weeksAs given in this study (human).
Source sentences
Summary
Diarrhea, dizziness, and vomiting were more common in the difelikefalin group than in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks.
Report a problemFND-3170288308
07HumanNon-randomized trialEfficacy outcome
In hemodialysis patients, difelikefalin significantly improved itch-related quality of life on the 5-D itch scale from baseline to week 12.
In plain wordsIn hemodialysis patients, itch-related quality of life improved from baseline with difelikefalin.
Peptide
Difelikefalin
Outcome
Direction not reported5-D itch quality of life
Study
n: not reported in source
Analysis
Secondary
Outcome group
Quality of life · Skin and wound
Studied dose
0.5 μg/kg three times per week · intravenous · 12 weeksAs given in this study (human).
Source sentences
Summary
Difelikefalin also resulted in a significant improvement from baseline to week 12 in itch-related quality of life as measured by the 5-D itch scale and the Skindex-10 scale.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks.
Report a problemFND-3170288303
08HumanNon-randomized trialEfficacy outcome
In hemodialysis patients, difelikefalin significantly improved itch-related quality of life on Skindex-10 from baseline to week 12.
In plain wordsIn hemodialysis patients, itch-related quality of life on Skindex-10 improved from baseline with difelikefalin.
Peptide
Difelikefalin
Outcome
Direction not reportedSkindex-10 quality of life
Study
n: not reported in source
Analysis
Secondary
Outcome group
Quality of life · Skin and wound
Studied dose
0.5 μg/kg three times per week · intravenous · 12 weeksAs given in this study (human).
Source sentences
Summary
Difelikefalin also resulted in a significant improvement from baseline to week 12 in itch-related quality of life as measured by the 5-D itch scale and the Skindex-10 scale.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned patients undergoing hemodialysis who had moderate-to-severe pruritus to receive either intravenous difelikefalin (at a dose of 0.5 μg per kilogram of body weight) or placebo three times per week for 12 weeks.
Report a problemFND-3170288304

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 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 page ClinicalTrials.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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
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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