Chronic Kidney DiseasesPhase 3NCT05342623
A Study to Evaluate the Safety and Efficacy of Difelikefalin in Advanced Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
A Phase 3 study testing Difelikefalin 1 mg Oral Tablet in people with Chronic Kidney Diseases and Pruritus, run by Cara Therapeutics, Inc. at 83 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Diseases, Pruritus
- What is being tested?
- Difelikefalin 1 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 83 sitesUnited States
- Study dates
- 17 May 2022to 29 Feb 2024
- Phase
- Phase 3
- 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 85 years
- 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:
- 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:
- Has recorded at least 4 WI-NRS scores during the 7-day Run-in Period; and
- 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.
Who cannot join
- 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.
Trial locations and contacts
83 sites in 1 country.
83 sites in 1 country
United States83 sites
Cara Therapeutics Study Site
Albany, Georgia, 31701
Cara Therapeutics Study Site
Anaheim, California, 92801
Cara Therapeutics Study Site
Ardmore, Oklahoma, 73401
Cara Therapeutics Study Site
Arvada, Colorado, 80002
Cara Therapeutics Study Site
Atlantis, Florida, 33462
Cara Therapeutics Study Site
Austin, Texas, 78751
Cara Therapeutics Study Site
Bakersfield, California, 93308
Cara Therapeutics Study Site
Baton Rouge, Louisiana, 70808
Cara Therapeutics Study Site
Bethlehem, Pennsylvania, 18107
Cara Therapeutics Study Site
Beverly Hills, California, 90211
Cara Therapeutics Study Site
Boston, Massachusetts, 02111
Cara Therapeutics Study Site
Cape Coral, Florida, 33914
Cara Therapeutics Study Site
Chattanooga, Tennessee, 37404
Cara Therapeutics Study Site
Chula Vista, California, 91910
Cara Therapeutics Study Site
Columbus, Ohio, 43215
Cara Therapeutics Study Site
Coral Gables, Florida, 33134
Cara Therapeutics Study Sites
Corsicana, Texas, 75110
Cara Therapeutics Study Site
Denver, Colorado, 80230
Cara Therapeutics Study Site
Durham, North Carolina, 27704
Cara Therapeutics Study Site
East Point, Georgia, 30344
Cara Therapeutics Study Site
East Providence, Rhode Island, 02914
Cara Therapeutics Study Site
El Centro, California, 92243
Cara Therapeutics Study Site
El Paso, Texas, 79902
Cara Therapeutics Study Site
Flint, Michigan, 48504
Cara Therapeutics Study Site
Fort Lauderdale, Florida, 33308
Cara Therapeutics Study Site
Garden Grove, California, 92844
Cara Therapeutics Study Site
Greenville, Texas, 75402
Cara Therapeutics Study Site
Hampton, Virginia, 23666
Cara Therapeutics Study Site
Hialeah, Florida, 33010
Cara Therapeutics Study Site
Houston, Texas, 77079
Cara Therapeutics Study Site
Houston, Texas, 77081
Cara Therapeutics Study Site 2
Houston, Texas, 77099
Cara Therapeutics Study Site
Huntley, Illinois, 60142
Cara Therapeutics Study Site
Huntsville, Alabama, 35805
Cara Therapeutics Study Site
Jackson, Tennessee, 38305
Cara Therapeutics Study Site
Kalamazoo, Michigan, 49007
Cara Therapeutics Study Site
Kansas City, Kansas, 48504
Cara Therapeutics Study Site
Kansas City, Missouri, 64131
Cara Therapeutics Study Site
Knoxville, Tennessee, 37924
Cara Therapeutics Study Site
La Mesa, California, 91942
Cara Therapeutics Study Site
Las Vegas, Nevada, 89128
Cara Therapeutics Study Site
Laurelton, New York, 11413
Cara Therapeutics Study Site
Lewisville, Texas, 75057
Cara Therapeutics Study Site
Lima, Ohio, 45805
Cara Therapeutics Study Site
Louisville, Kentucky, 40205
Cara Therapeutics Study Site
McAllen, Texas, 78503
Cara Therapeutics Study Site
McKinney, Texas, 75069
Cara Therapeutics Study Site
Metairie, Louisiana, 70006
Cara Therapeutics Study Site
Miami, Florida, 33143
Cara Therapeutics Study Site
Miami, Florida, 33173
Cara Therapeutics Study Site
Nampa, Idaho, 83687
Cara Therapeutics Study Site
New Haven, Connecticut, 06511
Cara Therapeutics Study Site
Northridge, California, 91324
Cara Therapeutics Study Site
Ontario, California, 91762
Cara Therapeutics Study Site
Orange City, Florida, 32763
Cara Therapeutics Study Site 2
Orlando, Florida, 32806
Cara Therapeutics Study Site
Orlando, Florida, 32808
Cara Therapeutics Study Site
Palos Hills, Illinois, 60465
Cara Therapeutics Study Site
Pasadena, Texas, 77504
Cara Therapeutics Study Site
Pembroke Pines, Florida, 33024
Cara Therapeutics Study Site
Phoenix, Arizona, 85016
Cara Therapeutics Study Site
Providence, Rhode Island, 02904
Cara Therapeutics Study Site
Riverside, California, 92505
Cara Therapeutics Study Site
Riverview, Florida, 33578
Cara Therapeutics Study Site
Roseville, Michigan, 48066
Cara Therapeutics Study Site
Saint Clair, Michigan, 48081
Cara Therapeutics Study Site
Saint Joseph, Michigan, 49085
Cara Therapeutics Study Site
Santa Clara, California, 91351
Cara Therapeutics Study Site
Sherman, Texas, 75090
Cara Therapeutics Study Site
Shreveport, Louisiana, 71101
Cara Therapeutics Study Site
South Gate, California, 90280
Cara Therapeutics Study Site
Spartanburg, South Carolina, 29302
Cara Therapeutics Study Site
Surprise, Arizona, 85374
Cara Therapeutics Study Site
Tampa, Florida, 33603
Cara Therapeutics Study Site
Tarzana, California, 91356
Cara Therapeutics Study Site
The Bronx, New York, 10455
Cara Therapeutics Study Site
Tupelo, Mississippi, 38801
Cara Therapeutics Study Site
Upland, Pennsylvania, 19013
Cara Therapeutics Study Site
Vacaville, California, 95687
Cara Therapeutics Study Site
Valencia, California, 91355
Cara Therapeutics Study Site
Victorville, California, 92392
Cara Therapeutics Study Site
West Palm Beach, Florida, 33401
Cara Therapeutics Study Site
Zachary, Louisiana, 70791
About this study
Official 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
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.
Read the detailed description
This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week double-blind Efficacy Assessment Phase (Treatment Period 1), a double-blind Long-term Extension Phase (Treatment Period 2) of up to 52 weeks, and a Follow-up Visit (7 to 10 days after the End of Treatment (EOT)/Early Termination (ET) Visit).
If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day Run-in Period, they will be randomized in a 1:1 ratio to receive once daily oral difelikefalin tablets at a dose of 1 mg or placebo for 12 weeks. Subjects will be stratified according to their use or nonuse of medications to treat pruritus prior to randomization as well as the presence or absence of specific medical conditions. During the Long-term Extension Phase, patients will be re-randomized on Day 1 of Treatment Period 2 to receive either oral difelikefalin 1 mg or placebo, once daily for up to an additional 52 weeks. A final safety Follow-up Visit will be conducted 7 to 10 days after the EOT/ET.
Informed consent will be obtained prior to performing any study-specific procedures. Screening will occur within 7 to 28 days prior to randomization to assess eligibility.
- Conditions
- Chronic Kidney Diseases, Pruritus
- Being tested
- Difelikefalin 1 mg Oral Tablet, Placebo Oral Tablet
- Keywords
- difelikefalin, CR845, Pruritus, Chronic Itch, Itch, Itching, uremic pruritus, CKD, CKD-aP, CKD-associated pruritus, Chronic Kidney Disease, Kidney dysfunction, Generalized pruritus, Hemodialysis, Dialysis, ESRD (end stage renal disease), Kidney failure, chronic
- Medical subject headings
- Renal Insufficiency, Chronic, Pruritus, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difelikefalin 1 mg Oral TabletDrug
Also called CR845
Difelikefalin 1 mg medication taken orally 1 time/day
Placebo Oral TabletDrug
Placebo tablet taken orally 1 time/day
| Study group | Role | What they receive |
|---|---|---|
| Difelikefalin 1 mg Oral Tablet | Experimental | Patients receive oral difelikefalin 1 mg once daily Receives: Drug: Difelikefalin 1 mg Oral Tablet |
| Placebo Oral Tablet | Placebo comparator | Patients receive oral placebo once daily Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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".
Measured: Week 12 of Treatment Period 1
Secondary outcomes (4)
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.
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".
Measured: Week 8 of Treatment Period 1
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.
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".
Measured: Week 4 of Treatment Period 1
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.
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".
Measured: Week 12 of Treatment Period 1
Efficacy Assessment Phase (Treatment Period 1): Change from baseline in Sleep Quality Questionnaire score at the end of Week 12 of Treatment Period 1.
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".
Measured: Week 12 of Treatment Period 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start17 May 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Why it stopped: Corporate decision to discontinue work in advanced chronic kidney disease.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cara Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cara Therapeutics, Study director, Cara Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342623
- Sponsor's protocol ID
- CR845-310301
- Status last verified
- May 2024
- First submitted
- 18 Apr 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wulczyn KE, Shafi T. CKD-Associated Pruritus: Updates on Management and Future Directions. Kidney360. 2026 Jul 1;7(7):1658-1661. doi: 10.34067/KID.0000001172. Epub 2026 Feb 13. No abstract available.
PubMed 41686509Didik S, Golosova D, Xu B, Staruschenko A. Opioids and the Kidney: A Compendium. Kidney360. 2023 Dec 1;4(12):1816-1823. doi: 10.34067/KID.0000000000000291. Epub 2023 Nov 6.
PubMed 37927032
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05342623
- Acronym / sponsor ID
- CR845-310301
- Conditions
- Chronic Kidney Diseases, Pruritus
- Keywords
- difelikefalin, CR845, Pruritus, Chronic Itch, Itch, Itching, uremic pruritus, CKD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corporate decision to discontinue work in advanced chronic kidney disease.
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 22 Apr 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, 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.
Detailed description
This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week double-blind Efficacy Assessment Phase (Treatment Period 1), a double-blind Long-term Extension Phase (Treatment Period 2) of up to 52 weeks, and a Follow-up Visit (7 to 10 days after the End of Treatment (EOT)/Early Termination (ET) Visit).
If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day Run-in Period, they will be randomized in a 1:1 ratio to receive once daily oral difelikefalin tablets at a dose of 1 mg or placebo for 12 weeks. Subjects will be stratified according to their use or nonuse of medications to treat pruritus prior to randomization as well as the presence or absence of specific medical conditions. During the Long-term Extension Phase, patients will be re-randomized on Day 1 of Treatment Period 2 to receive either oral difelikefalin 1 mg or placebo, once daily for up to an additional 52 weeks. A final safety Follow-up Visit will be conducted 7 to 10 days after the EOT/ET.
Informed consent will be obtained prior to performing any study-specific procedures. Screening will occur within 7 to 28 days prior to randomization to assess eligibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo controlled study
| Arm | Type | Receives |
|---|---|---|
| Difelikefalin 1 mg Oral Tablet | Experimental | Drug: Difelikefalin 1 mg Oral TabletPatients receive oral difelikefalin 1 mg once daily |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletPatients receive oral placebo once daily |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Has recorded at least 4 WI-NRS scores during the 7-day Run-in Period; and
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Difelikefalin 1 mg Oral TabletAlso: CR845Difelikefalin 1 mg medication taken orally 1 time/day | Drug | Difelikefalin 1 mg Oral Tablet |
| Placebo Oral TabletPlacebo tablet taken orally 1 time/day | Drug | Placebo Oral Tablet |
Primary outcome
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
Time frame: Week 12 of Treatment Period 1
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".
4 secondary outcomes
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.
Time frame: Week 8 of Treatment Period 1
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.
Time frame: Week 4 of Treatment Period 1
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.
Time frame: Week 12 of Treatment Period 1
Efficacy Assessment Phase (Treatment Period 1): Change from baseline in Sleep Quality Questionnaire score at the end of Week 12 of Treatment Period 1.
Time frame: Week 12 of Treatment Period 1
Results and safety
The study was stopped early (reason given: Corporate decision to discontinue work in advanced chronic kidney disease.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 41686509Wulczyn KE, Shafi T. CKD-Associated Pruritus: Updates on Management and Future Directions. Kidney360. 2026 Jul 1;7(7):1658-1661. doi: 10.34067/KID.0000001172. Epub 2026 Feb 13. No abstract available.
- Derived from this study: PubMed 37927032Didik S, Golosova D, Xu B, Staruschenko A. Opioids and the Kidney: A Compendium. Kidney360. 2023 Dec 1;4(12):1816-1823. doi: 10.34067/KID.0000000000000291. Epub 2023 Nov 6.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Diseases
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Cara Therapeutics study director
Cara Therapeutics
83 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Difelikefalin 1 mg Oral Tablet in people with Chronic Kidney Diseases and Pruritus, run by Cara Therapeutics, Inc. at 83 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 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 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?
The study was stopped early (reason given: Corporate decision to discontinue work in advanced chronic kidney disease.). 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.
What does the primary outcome measure?
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 (time frame: Week 12 of Treatment Period 1). 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 NCT05342623, which also lists 2 linked publications.
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 7 May 2024.