Efficacy and Safety of Difelikefalin in Japanese Patients With Moderate to Severe Pruritus Receiving Hemodialysis: A Randomized Clinical Trial.

Narita I, Tsubakihara Y, Uchiyama T, Okamura S, Oya N, Takahashi N, Gejyo F

JAMA network open2 May 2022Cited by 31 (Europe PMC)

PMID35511180PMCIDPMC9073569DOI10.1001/jamanetworkopen.2022.10339PepBankPUB-35511180

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Summary

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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.

01HumanRandomized controlled trialEfficacy outcome
In Japanese hemodialysis patients, NRS change with difelikefalin 0.25 μg/kg was -2.97 (SE 0.29), versus -2.86 (SE 0.29) with placebo.
In plain wordsIn Japanese hemodialysis patients, itch score changes were -2.97 with difelikefalin 0.25 μg/kg versus -2.86 with placebo.
Peptide
Difelikefalin
Outcome
Direction not reportedWorst Itching Intensity NRS change
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Skin and hair · Skin and wound
Studied dose
0.25 μg/kg three times a week · intravenous · 8 weeksAs given in this study (human).
Measurements
Adjusted mean change from baseline in Worst Itching Intensity NRS at week 8
−2.97 NRS score
difelikefalin 0.25 μg/kg
SE of adjusted mean change
0.29 NRS score
difelikefalin 0.25 μg/kg
Adjusted mean change from baseline in Worst Itching Intensity NRS at week 8
−2.86 NRS score
placebo
SE of adjusted mean change
0.29 NRS score
placebo
Source sentences
Summary
The changes from baseline in the adjusted mean (SE) of the 24-hour Worst Itching Intensity NRS score at week 8 were -2.86 (0.29) in the placebo group, -2.97 (0.29) in the 0.25 μg/kg of difelikefalin group, -3.65 (0.30) in the 0.5 μg/kg of difelikefalin group, and -3.64 (0.30) in the 1.0 μg/kg of difelikefalin group.
3 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan.
Summary · context
Patients with moderate to severe pruritus receiving hemodialysis were enrolled.
Summary · context
Difelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.
Report a problemFND-3551118001
02HumanRandomized controlled trialEfficacy outcome
In Japanese hemodialysis patients, difelikefalin 0.5 μg/kg reduced NRS by -3.65 (SE 0.30), with a -0.80 difference versus placebo (95% CI -1.55 to -0.04, P=.04).
In plain wordsIn Japanese hemodialysis patients, difelikefalin 0.5 μg/kg reduced itch significantly more than placebo.
Peptide
Difelikefalin
Outcome
DecreaseWorst Itching Intensity NRS change
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Skin and hair · Skin and wound
Studied dose
0.5 μg/kg three times a week · intravenous · 8 weeksAs given in this study (human).
Measurements
Adjusted mean change from baseline in Worst Itching Intensity NRS at week 8
−3.65 NRS score
difelikefalin 0.5 μg/kg
SE of adjusted mean change
0.3 NRS score
difelikefalin 0.5 μg/kg
Adjusted mean change from baseline in Worst Itching Intensity NRS at week 8
−2.86 NRS score
placebo
SE of adjusted mean change
0.29 NRS score
placebo
Adjusted mean difference versus placebo
−0.8 NRS score
difelikefalin 0.5 μg/kg
95% CI of adjusted mean difference
−1.55 to −0.04 NRS score
difelikefalin 0.5 μg/kg
P value
0.04
difelikefalin 0.5 μg/kg vs placebo
Source sentences
Summary
Significant differences were found in the 0.5 μg/kg of difelikefalin group (adjusted mean difference, -0.80; 95% CI, -1.55 to -0.04; P = .04) and the 1.0 μg/kg of difelikefalin group (adjusted mean difference, -0.78; 95% CI, -1.54 to -0.03; P = .04) compared with placebo.
4 context sentences(design, population, supporting numbers)
Summary · context
The changes from baseline in the adjusted mean (SE) of the 24-hour Worst Itching Intensity NRS score at week 8 were -2.86 (0.29) in the placebo group, -2.97 (0.29) in the 0.25 μg/kg of difelikefalin group, -3.65 (0.30) in the 0.5 μg/kg of difelikefalin group, and -3.64 (0.30) in the 1.0 μg/kg of difelikefalin group.
Summary · context
This randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan.
Summary · context
Patients with moderate to severe pruritus receiving hemodialysis were enrolled.
Summary · context
Difelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.
Report a problemFND-3551118002
03HumanRandomized controlled trialEfficacy outcome
In Japanese hemodialysis patients, difelikefalin 1.0 μg/kg reduced NRS by -3.64 (SE 0.30), with a -0.78 difference versus placebo (95% CI -1.54 to -0.03, P=.04).
In plain wordsIn Japanese hemodialysis patients, difelikefalin 1.0 μg/kg reduced itch significantly more than placebo.
Peptide
Difelikefalin
Outcome
DecreaseWorst Itching Intensity NRS change
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Skin and hair · Skin and wound
Studied dose
1.0 μg/kg three times a week · intravenous · 8 weeksAs given in this study (human).
Measurements
Adjusted mean change from baseline in Worst Itching Intensity NRS at week 8
−3.64 NRS score
difelikefalin 1.0 μg/kg
SE of adjusted mean change
0.3 NRS score
difelikefalin 1.0 μg/kg
Adjusted mean change from baseline in Worst Itching Intensity NRS at week 8
−2.86 NRS score
placebo
SE of adjusted mean change
0.29 NRS score
placebo
Adjusted mean difference versus placebo
−0.78 NRS score
difelikefalin 1.0 μg/kg
95% CI of adjusted mean difference
−1.54 to −0.03 NRS score
difelikefalin 1.0 μg/kg
P value
0.04
difelikefalin 1.0 μg/kg vs placebo
Source sentences
Summary
Significant differences were found in the 0.5 μg/kg of difelikefalin group (adjusted mean difference, -0.80; 95% CI, -1.55 to -0.04; P = .04) and the 1.0 μg/kg of difelikefalin group (adjusted mean difference, -0.78; 95% CI, -1.54 to -0.03; P = .04) compared with placebo.
4 context sentences(design, population, supporting numbers)
Summary · context
The changes from baseline in the adjusted mean (SE) of the 24-hour Worst Itching Intensity NRS score at week 8 were -2.86 (0.29) in the placebo group, -2.97 (0.29) in the 0.25 μg/kg of difelikefalin group, -3.65 (0.30) in the 0.5 μg/kg of difelikefalin group, and -3.64 (0.30) in the 1.0 μg/kg of difelikefalin group.
Summary · context
This randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan.
Summary · context
Patients with moderate to severe pruritus receiving hemodialysis were enrolled.
Summary · context
Difelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.
Report a problemFND-3551118003
04HumanRandomized controlled trialSafety outcome
In Japanese hemodialysis patients, adverse events occurred in 44 of 61 (72%) with difelikefalin 0.25 μg/kg versus 42 of 63 (67%) with placebo.
In plain wordsIn Japanese hemodialysis patients, adverse events occurred in 72% with difelikefalin 0.25 μg/kg versus 67% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseAdverse events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
0.25 μg/kg three times a week · intravenous · 8 weeksAs given in this study (human).
Measurements
Incidence of adverse events
72%
difelikefalin 0.25 μg/kg
Patients with adverse events
44 of 61 patients
difelikefalin 0.25 μg/kg
Incidence of adverse events
67%
placebo
Patients with adverse events
42 of 63 patients
placebo
Source sentences
Summary
The incidence of adverse events was 67% (42 of 63 patients) in the placebo group, 72% (44 of 61 patients) in the 0.25 μg/kg of difelikefalin group, 77% (47 of 61 patients) in the 0.5 μg/kg of difelikefalin group, and 85% (53 of 62 patients) in the 1.0 μg/kg of difelikefalin group.
3 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan.
Summary · context
Patients with moderate to severe pruritus receiving hemodialysis were enrolled.
Summary · context
Difelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.
Report a problemFND-3551118008
05HumanRandomized controlled trialSafety outcome
In Japanese hemodialysis patients, adverse events occurred in 47 of 61 (77%) with difelikefalin 0.5 μg/kg versus 42 of 63 (67%) with placebo.
In plain wordsIn Japanese hemodialysis patients, adverse events occurred in 77% with difelikefalin 0.5 μg/kg versus 67% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseAdverse events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
0.5 μg/kg three times a week · intravenous · 8 weeksAs given in this study (human).
Measurements
Incidence of adverse events
77%
difelikefalin 0.5 μg/kg
Patients with adverse events
47 of 61 patients
difelikefalin 0.5 μg/kg
Incidence of adverse events
67%
placebo
Patients with adverse events
42 of 63 patients
placebo
Source sentences
Summary
The incidence of adverse events was 67% (42 of 63 patients) in the placebo group, 72% (44 of 61 patients) in the 0.25 μg/kg of difelikefalin group, 77% (47 of 61 patients) in the 0.5 μg/kg of difelikefalin group, and 85% (53 of 62 patients) in the 1.0 μg/kg of difelikefalin group.
3 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan.
Summary · context
Patients with moderate to severe pruritus receiving hemodialysis were enrolled.
Summary · context
Difelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.
Report a problemFND-3551118009
06HumanRandomized controlled trialSafety outcome
In Japanese hemodialysis patients, adverse events occurred in 53 of 62 (85%) with difelikefalin 1.0 μg/kg versus 42 of 63 (67%) with placebo.
In plain wordsIn Japanese hemodialysis patients, adverse events occurred in 85% with difelikefalin 1.0 μg/kg versus 67% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseAdverse events
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
1.0 μg/kg three times a week · intravenous · 8 weeksAs given in this study (human).
Measurements
Incidence of adverse events
85%
difelikefalin 1.0 μg/kg
Patients with adverse events
53 of 62 patients
difelikefalin 1.0 μg/kg
Incidence of adverse events
67%
placebo
Patients with adverse events
42 of 63 patients
placebo
Source sentences
Summary
The incidence of adverse events was 67% (42 of 63 patients) in the placebo group, 72% (44 of 61 patients) in the 0.25 μg/kg of difelikefalin group, 77% (47 of 61 patients) in the 0.5 μg/kg of difelikefalin group, and 85% (53 of 62 patients) in the 1.0 μg/kg of difelikefalin group.
3 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan.
Summary · context
Patients with moderate to severe pruritus receiving hemodialysis were enrolled.
Summary · context
Difelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.
Report a problemFND-3551118010
07HumanNon-randomized trialEfficacy outcome
In Japanese hemodialysis patients, difelikefalin 0.5 μg/kg improved Skindex-16 score by -27.79 (SE 2.05, 95% CI -31.83 to -23.74).
In plain wordsIn Japanese hemodialysis patients, difelikefalin 0.5 μg/kg improved the Skindex-16 quality-of-life score.
Peptide
Difelikefalin
Outcome
DecreaseSkindex-16 overall score
Study
n: not reported in source
Analysis
Secondary
Outcome group
Skin and hair · Skin and wound
Studied dose
0.5 μg/kg three times a week · intravenous · 8 weeksAs given in this study (human).
Measurements
Adjusted weekly mean Skindex-16 overall score at week 8
−27.79 points
difelikefalin 0.5 μg/kg
SE of adjusted weekly mean
2.05 points
difelikefalin 0.5 μg/kg
95% CI of adjusted weekly mean
−31.83 to −23.74 points
difelikefalin 0.5 μg/kg
Source sentences
Summary
The Skindex-16 overall score and 5-D itch scale total score indicated an improvement with treatment with 0.5 and 1.0 μg/kg of difelikefalin (adjusted weekly mean [SE] Skindex-16 overall score at week 8, -27.79 [2.05]; 95% CI, -31.83 to -23.74 for 0.5 μg/kg of difelikefalin
3 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan.
Summary · context
Patients with moderate to severe pruritus receiving hemodialysis were enrolled.
Summary · context
Difelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.
Report a problemFND-3551118004
08HumanNon-randomized trialEfficacy outcome
In Japanese hemodialysis patients, difelikefalin 1.0 μg/kg improved Skindex-16 score by -22.69 (SE 2.04, 95% CI -26.71 to -18.68).
In plain wordsIn Japanese hemodialysis patients, difelikefalin 1.0 μg/kg improved the Skindex-16 quality-of-life score.
Peptide
Difelikefalin
Outcome
DecreaseSkindex-16 overall score
Study
n: not reported in source
Analysis
Secondary
Outcome group
Skin and hair · Skin and wound
Studied dose
1.0 μg/kg three times a week · intravenous · 8 weeksAs given in this study (human).
Measurements
Adjusted weekly mean Skindex-16 overall score at week 8
−22.69 points
difelikefalin 1.0 μg/kg
SE of adjusted weekly mean
2.04 points
difelikefalin 1.0 μg/kg
95% CI of adjusted weekly mean
−26.71 to −18.68 points
difelikefalin 1.0 μg/kg
Source sentences
Summary
adjusted weekly mean [SE] Skindex-16 overall score at week 8, -27.79 [2.05]; 95% CI, -31.83 to -23.74 for 0.5 μg/kg of difelikefalin and -22.69 [2.04]; 95% CI, -26.71 to -18.68 for 1.0 μg/kg of difelikefalin
3 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan.
Summary · context
Patients with moderate to severe pruritus receiving hemodialysis were enrolled.
Summary · context
Difelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.
Report a problemFND-3551118005
09HumanNon-randomized trialEfficacy outcome
In Japanese hemodialysis patients, difelikefalin 0.5 μg/kg improved 5-D itch score by -6.5 (SE 0.4, 95% CI -7.2 to -5.8).
In plain wordsIn Japanese hemodialysis patients, difelikefalin 0.5 μg/kg improved the 5-D itch score.
Peptide
Difelikefalin
Outcome
Decrease5-D itch scale total score
Study
n: not reported in source
Analysis
Secondary
Outcome group
Skin and hair · Skin and wound
Studied dose
0.5 μg/kg three times a week · intravenous · 8 weeksAs given in this study (human).
Measurements
Adjusted weekly mean 5-D itch scale total score at week 8
−6.5 points
difelikefalin 0.5 μg/kg
SE of adjusted weekly mean
0.4 points
difelikefalin 0.5 μg/kg
95% CI of adjusted weekly mean
−7.2 to −5.8 points
difelikefalin 0.5 μg/kg
Source sentences
Summary
adjusted weekly mean [SE] 5-D itch scale total score at week 8, -6.5 [0.4]; 95% CI, -7.2 to -5.8 for 0.5 μg/kg of difelikefalin
3 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan.
Summary · context
Patients with moderate to severe pruritus receiving hemodialysis were enrolled.
Summary · context
Difelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.
Report a problemFND-3551118006
10HumanNon-randomized trialEfficacy outcome
In Japanese hemodialysis patients, difelikefalin 1.0 μg/kg improved 5-D itch score by -6.8 (SE 0.3, 95% CI -7.5 to -6.2).
In plain wordsIn Japanese hemodialysis patients, difelikefalin 1.0 μg/kg improved the 5-D itch score.
Peptide
Difelikefalin
Outcome
Decrease5-D itch scale total score
Study
n: not reported in source
Analysis
Secondary
Outcome group
Skin and hair · Skin and wound
Studied dose
1.0 μg/kg three times a week · intravenous · 8 weeksAs given in this study (human).
Measurements
Adjusted weekly mean 5-D itch scale total score at week 8
−6.8 points
difelikefalin 1.0 μg/kg
SE of adjusted weekly mean
0.3 points
difelikefalin 1.0 μg/kg
95% CI of adjusted weekly mean
−7.5 to −6.2 points
difelikefalin 1.0 μg/kg
Source sentences
Summary
adjusted weekly mean [SE] 5-D itch scale total score at week 8, -6.5 [0.4]; 95% CI, -7.2 to -5.8 for 0.5 μg/kg of difelikefalin and -6.8 [0.3]; 95% CI, -7.5 to -6.2 for 1.0 μg/kg of difelikefalin).
3 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan.
Summary · context
Patients with moderate to severe pruritus receiving hemodialysis were enrolled.
Summary · context
Difelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.
Report a problemFND-3551118007
11HumanNon-randomized trialSafety outcome
In Japanese hemodialysis patients treated with difelikefalin, no dependency was reported.
In plain wordsIn Japanese hemodialysis patients treated with difelikefalin, no dependency was reported.
Peptide
Difelikefalin
Outcome
Direction not reportedDependency
Study
n: not reported in source
Outcome group
Adverse events · Nervous system and cognition
Studied dose
0.25, 0.5, and 1.0 μg/kg three times a week · intravenous · 8 weeksAs given in this study (human).
Source sentences
Summary
No dependency was reported.
3 context sentences(design, population, supporting numbers)
Summary · context
This randomized, double-blind, placebo-controlled, 4-arm phase 2 trial was conducted from February 1, 2019, to October 22, 2019, at 94 sites in Japan.
Summary · context
Patients with moderate to severe pruritus receiving hemodialysis were enrolled.
Summary · context
Difelikefalin (0.25, 0.5, and 1.0 μg/kg) and placebo were intravenously administered 3 times a week at the end of each hemodialysis session for 8 weeks.
Report a problemFND-3551118011

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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

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