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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
CR845-310302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Diseases 0 0
Pruritus 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 12 of Treatment Period 1
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 8 of Treatment Period 1
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Week 4 of Treatment Period 1
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Week 12 of Treatment Period 1
Secondary outcome [4] 0 0
Efficacy Assessment Phase (Treatment Period 1): Change from baseline in Sleep Quality Questionnaire score at the end of Week 12 of Treatment Period 1.
Timepoint [4] 0 0
Week 12 of Treatment Period 1

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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/02/2024
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cara Therapeutics Study Site - Adelaide
Recruitment hospital [2] 0 0
Cara Therapeutics Study Site - Camperdown
Recruitment hospital [3] 0 0
Cara Therapeutics Study Site - Concord
Recruitment hospital [4] 0 0
Cara Therapeutics Study Site - Gosford
Recruitment hospital [5] 0 0
Cara Therapeutics Study Site - Kogarah
Recruitment hospital [6] 0 0
Cara Therapeutics Study Site - Launceston
Recruitment hospital [7] 0 0
Cara Therapeutics Study Site - Liverpool
Recruitment hospital [8] 0 0
Cara Therapeutics Study Site - Melbourne
Recruitment hospital [9] 0 0
Cara Therapeutics Study Site - Saint Albans
Recruitment hospital [10] 0 0
Cara Therapeutics Study Site - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Concord
Recruitment postcode(s) [4] 0 0
- Gosford
Recruitment postcode(s) [5] 0 0
- Kogarah
Recruitment postcode(s) [6] 0 0
- Launceston
Recruitment postcode(s) [7] 0 0
- Liverpool
Recruitment postcode(s) [8] 0 0
- Melbourne
Recruitment postcode(s) [9] 0 0
- Saint Albans
Recruitment postcode(s) [10] 0 0
- Westmead
Recruitment outside Australia
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United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
Florida
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United States of America
State/province [3] 0 0
Georgia
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United States of America
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New York
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United States of America
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South Carolina
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United States of America
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Texas
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Argentina
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Ciudad Autonoma de Buenos Aire
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Argentina
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Corrientes
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Argentina
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Lanús
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Mar Del Plata
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San Nicolás
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Sarandí
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Belo Horizonte
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Joinville
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Salvador
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São José Do Rio Preto
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São Paulo
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Dobrich
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Gabrovo
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Montana
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Plovdiv
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Germany
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Baja
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Budapest
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Kistarcsa
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Pécs
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Italy
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Firenze
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Italy
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Modena
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Italy
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Pavia
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Italy
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Roma
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Korea, Republic of
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Daegu
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Goyang-si
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Seoul
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Mérida
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Golub-Dobrzyn
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Katowice
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Lódz
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Bucharest
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Oradea
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Valencia
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Vitoria

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cara Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05356403
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Cara Therapeutics, PhD
Address 0 0
Cara Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05356403