Study · Randomized controlled trial · n = 1,306 · 2022

14 results

Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program.

Fishbane S, Wen W, Munera C, Lin R, Bagal S, McCafferty K, Menzaghi F, Goncalves J

Kidney medicine28 Jun 2022Cited by 38 (Europe PMC)

PMID36039153PMCIDPMC9418597DOI10.1016/j.xkme.2022.100513PepBankPUB-36039153

Read at source 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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

01HumanRandomized controlled trialSafety outcome
In hemodialysis patients, diarrhea occurred in 9.0% with difelikefalin versus 5.7% with placebo.
In plain wordsIn hemodialysis patients, diarrhea occurred in 9.0% with difelikefalin versus 5.7% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseDiarrhea
Study
n = 848
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 mcg/kg · intravenousAs given in this study (human).
Measurements
Incidence of treatment-emergent diarrhea
9%
difelikefalin
Incidence of treatment-emergent diarrhea
5.7%
placebo
Source sentences
Summary
diarrhea (9.0% and 5.7%, respectively)
4 context sentences(design, population, supporting numbers)
Summary · context
occurring in ≥2% of participants receiving difelikefalin and with a ≥1% higher incidence than placebo
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915301
02HumanRandomized controlled trialSafety outcome
In hemodialysis patients, dizziness occurred in 6.8% with difelikefalin versus 3.8% with placebo.
In plain wordsIn hemodialysis patients, dizziness occurred in 6.8% with difelikefalin versus 3.8% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseDizziness
Study
n = 848
Comparator
Placebo
Outcome group
Adverse events · Nervous system and cognition
Studied dose
0.5 mcg/kg · intravenousAs given in this study (human).
Measurements
Incidence of treatment-emergent dizziness
6.8%
difelikefalin
Incidence of treatment-emergent dizziness
3.8%
placebo
Source sentences
Summary
dizziness (6.8% and 3.8%, respectively)
4 context sentences(design, population, supporting numbers)
Summary · context
occurring in ≥2% of participants receiving difelikefalin and with a ≥1% higher incidence than placebo
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915302
03HumanRandomized controlled trialSafety outcome
In hemodialysis patients, nausea occurred in 6.6% with difelikefalin versus 4.5% with placebo.
In plain wordsIn hemodialysis patients, nausea occurred in 6.6% with difelikefalin versus 4.5% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseNausea
Study
n = 848
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.5 mcg/kg · intravenousAs given in this study (human).
Measurements
Incidence of treatment-emergent nausea
6.6%
difelikefalin
Incidence of treatment-emergent nausea
4.5%
placebo
Source sentences
Summary
nausea (6.6% and 4.5%, respectively)
4 context sentences(design, population, supporting numbers)
Summary · context
occurring in ≥2% of participants receiving difelikefalin and with a ≥1% higher incidence than placebo
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915303
04HumanRandomized controlled trialSafety outcome
In hemodialysis patients, gait disturbances including falls occurred in 6.6% with difelikefalin versus 5.4% with placebo.
In plain wordsIn hemodialysis patients, gait disturbances including falls occurred in 6.6% with difelikefalin versus 5.4% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseGait disturbances including falls
Study
n = 848
Comparator
Placebo
Outcome group
Adverse events · Nervous system and cognition
Studied dose
0.5 mcg/kg · intravenousAs given in this study (human).
Measurements
Incidence of treatment-emergent gait disturbances, including falls
6.6%
difelikefalin
Incidence of treatment-emergent gait disturbances, including falls
5.4%
placebo
Source sentences
Summary
gait disturbances, including falls (6.6% and 5.4%, respectively)
4 context sentences(design, population, supporting numbers)
Summary · context
occurring in ≥2% of participants receiving difelikefalin and with a ≥1% higher incidence than placebo
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915304
05HumanRandomized controlled trialSafety outcome
In hemodialysis patients, hyperkalemia occurred in 4.7% with difelikefalin versus 3.5% with placebo.
In plain wordsIn hemodialysis patients, high potassium occurred in 4.7% with difelikefalin versus 3.5% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseHyperkalemia
Study
n = 848
Comparator
Placebo
Outcome group
Adverse events · Kidney and urinary
Studied dose
0.5 mcg/kg · intravenousAs given in this study (human).
Measurements
Incidence of treatment-emergent hyperkalemia
4.7%
difelikefalin
Incidence of treatment-emergent hyperkalemia
3.5%
placebo
Source sentences
Summary
hyperkalemia (4.7% and 3.5%, respectively)
4 context sentences(design, population, supporting numbers)
Summary · context
occurring in ≥2% of participants receiving difelikefalin and with a ≥1% higher incidence than placebo
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915305
06HumanRandomized controlled trialSafety outcome
In hemodialysis patients, headache occurred in 4.5% with difelikefalin versus 2.6% with placebo.
In plain wordsIn hemodialysis patients, headache occurred in 4.5% with difelikefalin versus 2.6% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseHeadache
Study
n = 848
Comparator
Placebo
Outcome group
Adverse events · Nervous system and cognition
Studied dose
0.5 mcg/kg · intravenousAs given in this study (human).
Measurements
Incidence of treatment-emergent headache
4.5%
difelikefalin
Incidence of treatment-emergent headache
2.6%
placebo
Source sentences
Summary
headache (4.5% and 2.6%, respectively)
4 context sentences(design, population, supporting numbers)
Summary · context
occurring in ≥2% of participants receiving difelikefalin and with a ≥1% higher incidence than placebo
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915306
07HumanRandomized controlled trialSafety outcome
In hemodialysis patients, somnolence occurred in 4.2% with difelikefalin versus 2.4% with placebo.
In plain wordsIn hemodialysis patients, sleepiness occurred in 4.2% with difelikefalin versus 2.4% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseSomnolence
Study
n = 848
Comparator
Placebo
Outcome group
Adverse events · Nervous system and cognition
Studied dose
0.5 mcg/kg · intravenousAs given in this study (human).
Measurements
Incidence of treatment-emergent somnolence
4.2%
difelikefalin
Incidence of treatment-emergent somnolence
2.4%
placebo
Source sentences
Summary
somnolence (4.2% and 2.4%, respectively)
4 context sentences(design, population, supporting numbers)
Summary · context
occurring in ≥2% of participants receiving difelikefalin and with a ≥1% higher incidence than placebo
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915307
08HumanRandomized controlled trialSafety outcome
In hemodialysis patients, mental status changes occurred in 3.3% with difelikefalin versus 1.4% with placebo.
In plain wordsIn hemodialysis patients, mental status changes occurred in 3.3% with difelikefalin versus 1.4% with placebo.
Peptide
Difelikefalin
Outcome
IncreaseMental status changes
Study
n = 848
Comparator
Placebo
Outcome group
Adverse events · Nervous system and cognition
Studied dose
0.5 mcg/kg · intravenousAs given in this study (human).
Measurements
Incidence of treatment-emergent mental status changes
3.3%
difelikefalin
Incidence of treatment-emergent mental status changes
1.4%
placebo
Source sentences
Summary
mental status changes (3.3% and 1.4%, respectively).
4 context sentences(design, population, supporting numbers)
Summary · context
occurring in ≥2% of participants receiving difelikefalin and with a ≥1% higher incidence than placebo
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915308
09HumanRandomized controlled trialSafety outcome
In hemodialysis patients, 3 difelikefalin recipients (0.7%) and 5 placebo recipients (1.2%) died during the study.
In plain wordsIn hemodialysis patients, deaths occurred in 0.7% with difelikefalin versus 1.2% with placebo.
Peptide
Difelikefalin
Outcome
DecreaseDeaths
Study
n = 848
Comparator
Placebo
Outcome group
Mortality · Whole body
Studied dose
0.5 mcg/kg · intravenousAs given in this study (human).
Measurements
Deaths
3 participants
difelikefalin group
Deaths
0.7%
difelikefalin group
Deaths
5 participants
placebo group
Deaths
1.2%
placebo group
Source sentences
Summary
Three participants (0.7%) in the difelikefalin group and 5 participants (1.2%) in the placebo group died during the study.
3 context sentences(design, population, supporting numbers)
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915314
10HumanNon-randomized trialSafety outcome
In hemodialysis patients, treatment-emergent adverse event rates did not increase with long-term difelikefalin exposure.
In plain wordsIn hemodialysis patients, adverse event rates did not increase with longer difelikefalin exposure.
Peptide
Difelikefalin
Outcome
No significant changeLong-term treatment-emergent adverse event rates
Study
n = 1,306
Comparator
Shorter exposure
Outcome group
Adverse events · Whole body
Studied dose
0.5 mcg/kg · intravenous · up to 64 weeksAs given in this study (human).
Source sentences
Summary
Incidence rates of TEAEs, serious TEAEs, and discontinuations because of TEAEs did not increase with long-term exposure.
3 context sentences(design, population, supporting numbers)
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915311
11HumanNon-randomized trialSafety outcome
In hemodialysis patients, serious treatment-emergent adverse event rates did not increase with long-term difelikefalin exposure.
In plain wordsIn hemodialysis patients, serious adverse event rates did not increase with longer difelikefalin exposure.
Peptide
Difelikefalin
Outcome
No significant changeLong-term serious treatment-emergent adverse event rates
Study
n = 1,306
Comparator
Shorter exposure
Outcome group
Adverse events · Whole body
Studied dose
0.5 mcg/kg · intravenous · up to 64 weeksAs given in this study (human).
Source sentences
Summary
Incidence rates of TEAEs, serious TEAEs, and discontinuations because of TEAEs did not increase with long-term exposure.
3 context sentences(design, population, supporting numbers)
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915312
12HumanNon-randomized trialSafety outcome
In hemodialysis patients, discontinuation rates because of treatment-emergent adverse events did not increase with long-term difelikefalin exposure.
In plain wordsIn hemodialysis patients, discontinuation rates from adverse events did not increase with longer difelikefalin exposure.
Peptide
Difelikefalin
Outcome
No significant changeLong-term discontinuation rates because of adverse events
Study
n = 1,306
Comparator
Shorter exposure
Outcome group
Adverse events · Whole body
Studied dose
0.5 mcg/kg · intravenous · up to 64 weeksAs given in this study (human).
Source sentences
Summary
Incidence rates of TEAEs, serious TEAEs, and discontinuations because of TEAEs did not increase with long-term exposure.
3 context sentences(design, population, supporting numbers)
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915313
13HumanNon-randomized trialSafety outcome
In hemodialysis patients, the common difelikefalin adverse events were mostly mild or moderate.
In plain wordsIn hemodialysis patients, common adverse events with difelikefalin were mostly mild or moderate.
Peptide
Difelikefalin
Outcome
Not applicableAdverse event severity
Study
n = 424
Outcome group
Adverse events · Whole body
Studied dose
0.5 mcg/kg · intravenousAs given in this study (human).
Source sentences
Summary
These were mostly mild or moderate, with few leading to discontinuation.
3 context sentences(design, population, supporting numbers)
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915309
14HumanNon-randomized trialSafety outcome
In hemodialysis patients, few common difelikefalin adverse events led to discontinuation.
In plain wordsIn hemodialysis patients, few common adverse events with difelikefalin led to treatment discontinuation.
Peptide
Difelikefalin
Outcome
Direction not reportedDiscontinuation from common adverse events
Study
n = 424
Outcome group
Adverse events · Whole body
Studied dose
0.5 mcg/kg · intravenousAs given in this study (human).
Source sentences
Summary
These were mostly mild or moderate, with few leading to discontinuation.
3 context sentences(design, population, supporting numbers)
Summary · context
KALM-1 and KALM-2 were randomized, double-blind, placebo-controlled, pivotal phase 3 studies; CLIN3101 (52 weeks) and CLIN3105 (12 weeks) were open-label studies.
Summary · context
Adults with moderate to severe CKD-aP treated by hemodialysis in North America, Europe, and the Asia-Pacific region.
Summary · context
At least 1 intravenous placebo or difelikefalin dose of 0.5 mcg/kg for up to 64 weeks.
Report a problemFND-3603915310

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

Registered trials4

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

4 trials · 4 completed · 4 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03998163

CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Cara Therapeutics, Inc.n = 2226 May 2019 to 6 Mar 2020

Uremic Pruritus

Trial page ClinicalTrials.govUpdated 15 Oct 2021

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 page ClinicalTrials.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 page ClinicalTrials.govUpdated 26 Apr 2022

CompletedPhase 3Results postedNCT03281538

Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Cara Therapeutics, Inc.n = 28814 Aug 2017 to 11 Feb 2020

Uremic Pruritus

Trial page ClinicalTrials.govUpdated 14 Oct 2021

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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Keywords

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