HemodialysisPhase 1NCT05533008
CR845-100303: Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
A Phase 1 study testing CR845 0.5 mcg/kg in people with Hemodialysis, run by Cara Therapeutics, Inc. at 5 sites in United States.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- CR845 0.5 mcg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Dec 2019to 11 Jun 2020
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has ESRD and has been on hemodialysis 3 times per week for at least 3 months;
- Not currently taking opioid medication;
- If female, is not pregnant or nursing during any period of the study.
Who cannot join
- Has a concomitant disease or a history of any 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; Past or present diseases, which as judged by the Investigator, may affect the outcome of this study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cara Therapeutics Study Site
Bridgeport, Connecticut, 06606
Cara Therapeutics Study Site
Hartford, Connecticut, 06112
Cara Therapeutics Study Site
Kansas City, Kansas, 64111
Cara Therapeutics Study Site
Minneapolis, Minnesota, 55404
Cara Therapeutics Study Site
Roseville, Michigan, 48066
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in hemodialysis patients. The purpose of this study is to determine whether hemodialysis patients who take CR845 develop physical dependence and experience withdrawal symptoms upon cessation, as exemplified by symptoms consistent with opioid withdrawal. The study will consist of a Screening Phase, a 3-week Open-label Phase, a 2-week randomized, placebo-controlled, Double-blind Phase and a Follow-up Visit.
- Conditions
- Hemodialysis
- Being tested
- CR845 0.5 mcg/kg, Placebo
- Keywords
- Difelikefalin, CR845, Physical Withdrawal, Hemodialysis, Dialysis, CKD, ESRD (end stage renal disease), Chronic Kidney Disease, Kidney failure, chronic, Kidney dysfunction
- Medical subject headings
- 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.
CR845 0.5 mcg/kgDrug
Also called Difelikefalin
IV CR845 0.5 mcg/kg as a bolus injection
PlaceboOther
IV Placebo as a bolus injection
| Study group | Role | What they receive |
|---|---|---|
| CR845 0.5 mcg/kg | Experimental | IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) Receives: Drug: CR845 0.5 mcg/kg |
| Placebo | Placebo comparator | IV Placebo administered after each dialysis session (3 times/week) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment difference between placebo and CR845-treated group with respect to the maximum Clinical Opiate Withdrawal Scale (COWS) score over Weeks 1-4
Measured: Week 1-4
Secondary outcomes (5)
Treatment difference between placebo and CR845-treated group for COWS score at Week 4.
Measured: Week 4
Treatment difference between placebo and CR845-treated group for COWS score at Week 5.
Measured: Week 5
Treatment difference between placebo and CR845-treated group for maximum Subjective Opiate Withdrawal Scale (SOWS) score over Weeks 1-4
Measured: Week 1-4
Treatment difference between placebo and CR845-treated group for SOWS score at Week 4.
Measured: Week 4
Treatment difference between placebo and CR845-treated group for SOWS score at Week 5.
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start31 Dec 2019
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédérique Menzaghi, PhD, Study director, Cara Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05533008
- Sponsor's protocol ID
- CR845-100303
- Status last verified
- Sep 2022
- First submitted
- 19 Nov 2019
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Potential of Physical Withdrawal From Intravenous CR845 (Difelikefalin) in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05533008
- Acronym / sponsor ID
- CR845-100303
- Conditions
- Hemodialysis
- Keywords
- Difelikefalin, CR845, Physical Withdrawal, Hemodialysis, Dialysis, CKD, ESRD (end stage renal disease), Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 8 Sep 2022 (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 a multicenter, randomized, double-blind, placebo-controlled study to assess the potential of physical withdrawal from CR845 upon treatment discontinuation after 3 weeks of IV administration at a dose of 0.5 mcg/kg in hemodialysis patients. The purpose of this study is to determine whether hemodialysis patients who take CR845 develop physical dependence and experience withdrawal symptoms upon cessation, as exemplified by symptoms consistent with opioid withdrawal. The study will consist of a Screening Phase, a 3-week Open-label Phase, a 2-week randomized, placebo-controlled, Double-blind Phase and a Follow-up Visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CR845 0.5 mcg/kg | Experimental | Drug: CR845 0.5 mcg/kgIV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) |
| Placebo | Placebo comparator | Other: PlaceboIV Placebo administered after each dialysis session (3 times/week) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has ESRD and has been on hemodialysis 3 times per week for at least 3 months;
- Not currently taking opioid medication;
- If female, is not pregnant or nursing during any period of the study.
Key exclusion criteria (1 listed)
- Has a concomitant disease or a history of any 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; Past or present diseases, which as judged by the Investigator, may affect the outcome of this study.
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 |
|---|---|---|
| CR845 0.5 mcg/kgAlso: DifelikefalinIV CR845 0.5 mcg/kg as a bolus injection | Drug | CR845 0.5 mcg/kg |
| PlaceboIV Placebo as a bolus injection | Other | Placebo |
Primary outcome
Treatment difference between placebo and CR845-treated group with respect to the maximum Clinical Opiate Withdrawal Scale (COWS) score over Weeks 1-4
Time frame: Week 1-4
5 secondary outcomes
Treatment difference between placebo and CR845-treated group for COWS score at Week 4.
Time frame: Week 4
Treatment difference between placebo and CR845-treated group for COWS score at Week 5.
Time frame: Week 5
Treatment difference between placebo and CR845-treated group for maximum Subjective Opiate Withdrawal Scale (SOWS) score over Weeks 1-4
Time frame: Week 1-4
Treatment difference between placebo and CR845-treated group for SOWS score at Week 4.
Time frame: Week 4
Treatment difference between placebo and CR845-treated group for SOWS score at Week 5.
Time frame: Week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Frédérique Menzaghi, PhD study director
Cara Therapeutics
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CR845 0.5 mcg/kg in people with Hemodialysis, run by Cara Therapeutics, Inc. at 5 sites in United States.
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 3 inclusion and 1 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 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Treatment difference between placebo and CR845-treated group with respect to the maximum Clinical Opiate Withdrawal Scale (COWS) score over Weeks 1-4 (time frame: Week 1-4). It is what the study was designed to measure, not a finding.
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 8 Sep 2022.