Uremic PruritusPhase 3NCT03281538
Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
A Phase 3 study testing CR845 in people with Uremic Pruritus, run by Cara Therapeutics, Inc. at 27 sites in 2 countries.
Trial summary
This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks. 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?
- CR845
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 27 sitesin 2 countries
- Study dates
- 14 Aug 2017to 11 Feb 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for inclusion into the study, a patient must meet the following criteria:
- Willing and able to provide written informed consent prior to participating in this study;
- Able to communicate clearly with the Investigator and staff, able to understand the study procedures, and able and willing to comply with the study schedules and all study requirements;
- Males or females 18 years of age or older;
- Currently on hemodialysis for end-stage renal disease and has been categorized as experiencing moderate to severe uremic pruritus;
- If female:
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- Is not of childbearing potential (surgically sterile or postmenopausal, as defined in Section 6.5.1.6); or
- Has a negative serum pregnancy test at screening and agrees to use acceptable contraceptive measures (as defined in Section 6.5.1.6) from the time of informed consent until the safety Follow-up Visit or 7 days after the last dose of study drug, whichever is later.
- If male, agrees not to donate sperm after the first dose of study drug until 7 days after the last dose, and agrees to use a condom with spermicide or abstain from heterosexual intercourse during the study until 7 days after study drug administration. (Note: No restrictions are required for a vasectomized male provided his vasectomy was performed ≥4 months prior to dosing);
- Has a dry body weight of ≥40.0 kg at screening (prescription target dry body weight);
- Has adequacy of dialysis, defined as meeting 1 of the following criteria during the 3 months prior to screening:
- ≥2 single pool Kt/V measurements ≥1.2; or
- ≥2 urea reduction ratio measurements ≥65%; or
- 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65%
Who cannot join
- A patient will be excluded from the study if any of the following criteria are met:
- Received an investigational drugwithin 30 days prior to the first dose of study drug, or is planning to participate in another interventional clinical study while enrolled in this study.
- Has a concomitant disease or any medical condition that, in the opinion of the Investigator, could pose undue risk to the patient, impede completion of the study procedures, or would compromise the validity of the study measurements, including, but not limited to:
- Known or suspected history of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, -diagnosed alcohol, narcotic or other drug abuse, or substance dependence within 12 months prior to screening;
- New York Heart Association Class IV congestive heart failure (Appendix 1, Section 14.0);
- Severe mental illness or cognitive impairment (eg, dementia);
- Any other relevant acute or chronic medical or neuropsychiatric condition;
Trial locations and contacts
27 sites in 2 countries.
27 sites in 2 countries
United States26 sites
Cara Therapeutics Study Site
Albany, Georgia, 31701
Cara Therapeutics Study Site
Albuquerque, New Mexico, 87109
Cara Therapeutics Study Site
Augusta, Georgia, 30909
Cara Therapeutics Study Site
Bethlehem, Pennsylvania, 18017
Cara Therapeutics Study Site
Chula Vista, California, 91990
Cara Therapeutics Study Site
Denver, Colorado, 80230
Cara Therapeutics Study Site
El Centro, California, 92243
Cara Therapeutics Study Site
El Paso, Texas, 79902
Cara Therapeutics Study Site
Gallup, New Mexico, 87301
Cara Therapeutics Study Site
Hollywood, Florida, 33024
Cara Therapeutics Study Site
Kansas City, Missouri, 64131
Cara Therapeutics Study Site
Knoxville, Tennessee, 37920
Cara Therapeutics Study Site
Long Beach, California, 90813
Cara Therapeutics Study Site
Meridian, Idaho, 83642
Cara Therapeutics Study Site
Mineola, New York, 11501
Cara Therapeutics Study Site
Northridge, California, 91324
Cara Therapeutics Study Site
Ridgewood, New York, 11385
Cara Therapeutics Study Site
Roseville, Michigan, 48066
Cara Therapeutics Study Site
San Antonio, Texas, 78202
Cara Therapeutics Study Site
San Antonio, Texas, 78221
Cara Therapeutics Study Site
San Antonio, Texas, 78229
Cara Therapeutics Study Site
Springfield, Massachusetts, 01107
Cara Therapeutics Study Site
St. George, Utah, 84790
Cara Therapeutics Study Site
Tampa, Florida, 33614
Cara Therapeutics Study Site
Wauwatosa, Wisconsin, 53326
Cara Therapeutics Study Site
Winter Park, Florida, 32789
About this study
Official title: An Open-Label, Multicenter, Extension Study to Evaluate the Long Term Safety of Intravenous CR845 in Hemodialysis Patients With Chronic Kidney Disease-Associated Pruritus
This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.
Read the detailed description
This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks. This study will consist of a Screening Visit, a 52 week Treatment Period, and a Follow-up Visit. Informed consent will be obtained prior to performing any study-specific procedures. All patients will have a Screening Visit, which can be performed anytime within 14 days prior to the first dose of study drug, to confirm eligibility.
Clinical laboratory tests, electrocardiograms (ECGs), vital signs, adverse events, and concomitant medications will be monitored throughout the study. Blood samples for inflammatory biomarkers will be collected from all patients prior to dialysis on Day 1 and periodically until the End of Treatment or Early Termination Visit. Blood samples will also be collected periodically for clinical laboratory tests.
- Conditions
- Uremic Pruritus
- Being tested
- CR845
- Keywords
- CR845, difelikefalin, Pruritus, Chronic Itch, Itch, Itching, hemodialysis, Uremic Pruritus, Dialysis, CKD, CKD-associated pruritus, CKD-aP, ESRD (end stage renal disease), Chronic Kidney Disease, Kidney failure, chronic, Kidney dysfunction, Generalized pruritus
- 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.
CR845Drug
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
| Study group | Role | What they receive |
|---|---|---|
| CR845 0.5mcg/kg | Experimental | CR845 0.5mcg/kg IV medication administered three times/week after dialysis Receives: Drug: CR845 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With AEs
Assessed by physical examination, monitoring of adverse events, vital signs and laboratory assessments
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start14 Aug 2017
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederique Menzaghi, Study director, Cara Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281538
- Sponsor's protocol ID
- CR845-CLIN3101
- Status last verified
- Sep 2021
- First submitted
- 20 Jun 2017
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fishbane S, Wen W, Munera C, Lin R, Bagal S, McCafferty K, Menzaghi F, Goncalves J. 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. Kidney Med. 2022 Jun 28;4(8):100513. doi: 10.1016/j.xkme.2022.100513. eCollection 2022 Aug.
PubMed 36039153
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Extension Study to Evaluate the Long Term Safety of Intravenous CR845 in Hemodialysis Patients With Chronic Kidney Disease-Associated Pruritus
- ClinicalTrials.gov ID
- NCT03281538
- Acronym / sponsor ID
- CR845-CLIN3101
- Conditions
- Uremic Pruritus
- Keywords
- CR845, difelikefalin, Pruritus, Chronic Itch, Itch, Itching, hemodialysis, Uremic Pruritus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Posted 14 Oct 2021
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 open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks.
Detailed description
This is an open-label multicenter, long-term extension safety study to evaluate the safety of IV CR845 administered after each dialysis session over a Treatment Period of up to 52 weeks. This study will consist of a Screening Visit, a 52 week Treatment Period, and a Follow-up Visit. Informed consent will be obtained prior to performing any study-specific procedures. All patients will have a Screening Visit, which can be performed anytime within 14 days prior to the first dose of study drug, to confirm eligibility.
Clinical laboratory tests, electrocardiograms (ECGs), vital signs, adverse events, and concomitant medications will be monitored throughout the study. Blood samples for inflammatory biomarkers will be collected from all patients prior to dialysis on Day 1 and periodically until the End of Treatment or Early Termination Visit. Blood samples will also be collected periodically for clinical laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CR845 0.5mcg/kg | Experimental | Drug: CR845CR845 0.5mcg/kg IV medication administered three times/week after dialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to provide written informed consent prior to participating in this study;
- Able to communicate clearly with the Investigator and staff, able to understand the study procedures, and able and willing to comply with the study schedules and all study requirements;
- Males or females 18 years of age or older;
- Currently on hemodialysis for end-stage renal disease and has been categorized as experiencing moderate to severe uremic pruritus;
- If female:
Key exclusion criteria (7 listed)
- Received an investigational drugwithin 30 days prior to the first dose of study drug, or is planning to participate in another interventional clinical study while enrolled in this study.
- Has a concomitant disease or any medical condition that, in the opinion of the Investigator, could pose undue risk to the patient, impede completion of the study procedures, or would compromise the validity of the study measurements, including, but not limited to:
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 |
|---|---|---|
| CR845IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) | Drug | CR845 0.5mcg/kg |
Primary outcome
Number of Participants With AEs
Time frame: Up to 52 weeks
Assessed by physical examination, monitoring of adverse events, vital signs and laboratory assessments
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36039153Fishbane S, Wen W, Munera C, Lin R, Bagal S, McCafferty K, Menzaghi F, Goncalves J. 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. Kidney Med. 2022 Jun 28;4(8):100513. doi: 10.1016/j.xkme.2022.100513. eCollection 2022 Aug.
- Individual participant dataSharing planned: Undecided
Related trials for Uremic Pruritus
Active, not recruitingObservational study
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
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.
Frederique Menzaghi study director
Cara Therapeutics
27 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CR845 in people with Uremic Pruritus, run by Cara Therapeutics, Inc. at 27 sites in 2 countries.
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 14 inclusion and 7 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: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Participants With AEs (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03281538, which also lists 1 linked publication.
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 14 Oct 2021.