Uremic PruritusNCT05031546
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
A study testing Difelikefalin in people with Uremic Pruritus, run by Cara Therapeutics, Inc..
Trial summary
This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uremic Pruritus
- What is being tested?
- Difelikefalin
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years old;
- Has end-stage renal disease (ESRD) and is currently receiving in-center hemodialysis;
- Has moderate-to-severe pruritus attributed to ESRD which is significantly impacting the patient's quality of life;
- Has no comparable or satisfactory alternative therapy for the treatment of moderate-to-severe pruritus, as determined by the sponsor-investigator.
Who cannot join
- Has severe hepatic impairment (Child-Pugh class C), as the influence of severe hepatic impairment on the pharmacokinetics of difelikefalin has not been evaluated;
- Is pregnant or nursing;
- Has been exposed to any other investigational medication in the past 60 days;
- Present any other reason which may lead to an unfavorable risk-benefit ratio for treatment with difelikefalin, as determined by the sponsor-investigator;
- Has a known or suspected allergy to difelikefalin or any component of the investigational product.
About this study
This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis.
Read the detailed description
Visits during the expanded access program will consist of a Baseline Visit to confirm eligibility and an End of Treatment visit. Patients will receive IV difelikefalin at a dose of 0.5 mcg/kg after each dialysis session, generally 3 times per week. The End of Treatment visit will be defined as the first dialysis visit following the last dose of IV difelikefalin under the intermediate-size patient population expanded access protocol.
- Conditions
- Uremic Pruritus
- Being tested
- Difelikefalin
- Keywords
- Hemodialysis, Pruritus, Uremic Pruritus, Dialysis, CR845, Difelikefalin, Chronic Itch, CKD, CKD-associated pruritus, CKD-aP, ESRD (end stage renal disease), Itch, Itching, KALM, Chronic Kidney Disease, Kidney failure, chronic, Kidney dysfunction, Generalized pruritus, Expanded access, Compassionate use
- Medical subject headings
- Pruritus, Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DifelikefalinDrug
IV Difelikefalin 0.5 mcg/kg administered after each dialysis session (3 times/week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uremic PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cara Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031546
- Sponsor's protocol ID
- CR845-500301
- Status last verified
- May 2022
- First submitted
- 26 Aug 2021
- Last updated
- 18 May 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin
- ClinicalTrials.gov ID
- NCT05031546
- Acronym / sponsor ID
- CR845-500301
- Conditions
- Uremic Pruritus
- Keywords
- Hemodialysis, Pruritus, Uremic Pruritus, Dialysis, CR845, Difelikefalin, Chronic Itch, CKD
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis.
Detailed description
Visits during the expanded access program will consist of a Baseline Visit to confirm eligibility and an End of Treatment visit. Patients will receive IV difelikefalin at a dose of 0.5 mcg/kg after each dialysis session, generally 3 times per week. The End of Treatment visit will be defined as the first dialysis visit following the last dose of IV difelikefalin under the intermediate-size patient population expanded access protocol.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 18 years old;
- Has end-stage renal disease (ESRD) and is currently receiving in-center hemodialysis;
- Has moderate-to-severe pruritus attributed to ESRD which is significantly impacting the patient's quality of life;
- Has no comparable or satisfactory alternative therapy for the treatment of moderate-to-severe pruritus, as determined by the sponsor-investigator.
Key exclusion criteria (5 listed)
- Has severe hepatic impairment (Child-Pugh class C), as the influence of severe hepatic impairment on the pharmacokinetics of difelikefalin has not been evaluated;
- Is pregnant or nursing;
- Has been exposed to any other investigational medication in the past 60 days;
- Present any other reason which may lead to an unfavorable risk-benefit ratio for treatment with difelikefalin, as determined by the sponsor-investigator;
- Has a known or suspected allergy to difelikefalin or any component of the investigational product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DifelikefalinIV Difelikefalin 0.5 mcg/kg administered after each dialysis session (3 times/week) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Related trials for Uremic Pruritus
Active, not recruitingObservational study
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End-Stage Kidney Disease (ESKD), Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Difelikefalin in people with Uremic Pruritus, run by Cara Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.