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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05356403
Registration number
NCT05356403
Ethics application status
Date submitted
18/04/2022
Date registered
2/05/2022
Date last updated
7/05/2024
Titles & IDs
Public title
CR845-310302: A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
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Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled 12-Week Study to Evaluate the Safety and Efficacy of Oral Difelikefalin in Advanced Chronic Kidney Disease Subjects With Moderate-to-Severe Pruritus With an up to 52-Week Long-term Extension
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Secondary ID [1]
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CR845-310302
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Diseases
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Pruritus
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Renal and Urogenital
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Other renal and urogenital disorders
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Difelikefalin 1 mg Oral Tablet
Treatment: Drugs - Placebo Oral Tablet
Experimental: Difelikefalin 1 mg Oral Tablet - Patients receive oral difelikefalin 1 mg once daily
Placebo Comparator: Placebo Oral Tablet - Patients receive oral placebo once daily
Treatment: Drugs: Difelikefalin 1 mg Oral Tablet
Difelikefalin 1 mg medication taken orally 1 time/day
Treatment: Drugs: Placebo Oral Tablet
Placebo tablet taken orally 1 time/day
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the daily 24-hour WI-NRS score at Week 12 of Treatment Period 1
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Assessment method [1]
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Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".
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Timepoint [1]
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Week 12 of Treatment Period 1
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Secondary outcome [1]
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Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the WI-NRS at Week 8 of Treatment Period 1.
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Assessment method [1]
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Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".
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Timepoint [1]
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Week 8 of Treatment Period 1
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Secondary outcome [2]
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Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects achieving at least a 4-point improvement from baseline with respect to the weekly mean of the WI-NRS at Week 4 of Treatment Period 1.
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Assessment method [2]
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Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".
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Timepoint [2]
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Week 4 of Treatment Period 1
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Secondary outcome [3]
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Efficacy Assessment Phase (Treatment Period 1): Proportion of subjects who are "complete itch responders" defined as subjects with = 70% of the non-missing 24-hour WI-NRS scores equal to 0 or 1 at Week 12 of Treatment Period 1.
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Assessment method [3]
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Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable".
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Timepoint [3]
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Week 12 of Treatment Period 1
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Secondary outcome [4]
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Efficacy Assessment Phase (Treatment Period 1): Change from baseline in Sleep Quality Questionnaire score at the end of Week 12 of Treatment Period 1.
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Assessment method [4]
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Sleep Quality will be measured using an NRS used to indicate how much itch has interfered with sleep during the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "did not interfere" and "10" represents "completely interfered".
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Timepoint [4]
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Week 12 of Treatment Period 1
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Eligibility
Key inclusion criteria
To be eligible for inclusion into the study, a patient must meet the following criteria:
- Advanced stage 4 and 5 CKD and end stage renal disease on hemodialysis
- Subject self-reports experiencing at least near-daily (eg, most days of a week)
pruritus for at least 6 months prior to screening.
- Inadequate response to current or prior treatments (including emollients/moisturizers,
topical medications, or systemic treatments) for pruritus prior to screening.
Prior to randomization on Day 1 of Treatment Period 1:
1. Has recorded at least 4 WI-NRS scores during the 7-day Run-in Period; and
2. Has a mean baseline WI-NRS score = 5, defined as the average of all non-missing scores
reported during the 7-day Run-in Period.
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Minimum age
18
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
A patient will be excluded from the study if any of the following criteria are met:
- Scheduled to receive a renal replacement therapy (dialysis or kidney transplant)
during the study.
- Has a concomitant disease, significant medical condition or
physical/laboratory/ECG/vital signs abnormality that, in the opinion of the
investigator, puts the subject at undue risk or interferes with interpretation of
study results, impedes completion of the study procedures, or compromises the validity
of the study measurements.
- New or change of treatment received for itch, including antihistamines and
corticosteroids (oral, intravenous, or topical), within 14 days prior to the start of
run-in.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/02/2024
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Sample size
Target
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Accrual to date
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Final
105
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Cara Therapeutics Study Site - Adelaide
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Cara Therapeutics Study Site - Camperdown
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Recruitment hospital [3]
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Cara Therapeutics Study Site - Concord
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Cara Therapeutics Study Site - Gosford
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Cara Therapeutics Study Site - Kogarah
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Cara Therapeutics Study Site - Launceston
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Cara Therapeutics Study Site - Liverpool
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Cara Therapeutics Study Site - Melbourne
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Recruitment hospital [9]
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Cara Therapeutics Study Site - Saint Albans
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Recruitment hospital [10]
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Cara Therapeutics Study Site - Westmead
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Recruitment postcode(s) [1]
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- Adelaide
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- Camperdown
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- Concord
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- Gosford
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- Kogarah
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- Launceston
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- Liverpool
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- Melbourne
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- Saint Albans
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- Westmead
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Recruitment outside Australia
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United States of America
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California
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Florida
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Vitoria
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Cara Therapeutics, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the
safety and efficacy of oral difelikefalin administered as a 1 mg tablet once daily compared
to placebo in reducing the intensity of itch in advanced chronic kidney disease (CKD)
patients with moderate-to-severe pruritus. This study is comprised of an Efficacy Assessment
Phase and a Long-term Extension Phase. The Efficacy Assessment Phase includes a double-blind
12-week Treatment Period (Treatment Period 1), and the Long-term Extension Phase includes a
double-blind Treatment Period (Treatment Period 2) of up to 52 weeks.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05356403
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Cara Therapeutics, PhD
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Address
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Cara Therapeutics
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05356403
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