Uremic PruritusPhase 3NCT03422653

A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)

A Phase 3 study testing CR845 0.5 mcg/kg in people with Uremic Pruritus, run by Cara Therapeutics, Inc. at 57 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week Double-blind Phase and a 52-week Open-label Extension Phase. 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 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: 378 participants
Where: 57 sitesUnited States
Study dates: 20 Feb 2018to 26 Mar 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 Double-blind Phase of the study, a patient must meet the following criteria:
Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for at least 3 months prior to the start of screening;
Has at least 2 single-pool Kt/V measurements ≥1.2, or at least 2 urea reduction ratio measurements ≥65%, or 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% on different dialysis days during the 3 months period prior to screening;
Prior to randomization:
Has completed Worst Itching Intensity NRS worksheets up to 8 days prior to 1st dose;
Has a mean baseline Worst Itching Intensity NRS indicative of moderate to severe uremic pruritus.

Show all 9Show fewer

To be eligible for inclusion into the Open-label Extension Phase of the study, each patient will have to fulfill the additional key following criteria at the time of entry into the Open-label Extension Phase:
Has received at least 30 doses of the planned 36 doses of study drug during the Double-blind Phase of this study;
Continues to meet inclusion criteria.

Who cannot join

A patient will be excluded from the Double-blind Phase of the study if any of the following criteria are met:
Known noncompliance with dialysis treatment that in the opinion of the investigator would impede completion or validity of the study;
Scheduled to receive a kidney transplant during the study;
New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening;
Received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study;
Has pruritus only during the dialysis session (by patient report);

Show all 11Show fewer

Is receiving ongoing ultraviolet B and anticipates receiving such treatment during the study;
Participated in a previous clinical study with CR845.
A patient will be excluded from the Open-label Extension Phase of the study if any of the additional key following criteria are met at the time of entry into the Open-label Extension Phase:
Completed the Double-blind Phase of this study but exhibited adverse events during the course of the Treatment Period that may preclude continued exposure to the study drug;
Was noncompliant with protocol procedures during the Double-blind Phase of this study which is indicative of an inability to follow protocol procedures.

Trial locations and contacts

57 sites in 1 country.

City, postcode or hospital

57 sites in 1 country

United States57 sites

Cara Therapeutics Study Site
Albuquerque, New Mexico, 87109
Cara Therapeutics Study Site
Bakersfield, California, 93309-5030
Cara Therapeutics Study Site 2
Beverly Hills, California, 90211
Cara Therapeutics Study Site
Beverly Hills, California, 90211
Cara Therapeutics Study Site
Bridgeport, Connecticut, 06606
Cara Therapeutics Study Site
Brookhaven, Mississippi, 39601
Cara Therapeutics Study Site
Canton, Ohio, 44718
Cara Therapeutics Study Site
Chattanooga, Tennessee, 37408
Cara Therapeutics Study Site
Chesapeake, Virginia, 23320
Cara Therapeutics Study Site
Chula Vista, California, 91910
Cara Therapeutics Study Site 1
Coral Springs, Florida, 33071
Cara Therapeutics Study Site
Corona, California, 92881
Cara Therapeutics Study Site
Dallas, Texas, 75231
Cara Therapeutics Study Site
Denver, Colorado, 80218
Cara Therapeutics Study Site
Duncanville, Texas, 75137
Cara Therapeutics Study Site
Durham, North Carolina, 27704
Cara Therapeutics Study Site
Eatontown, New Jersey, 07724
Cara Therapeutics Study Site
Escondido, California, 92025
Cara Therapeutics Study Site
Fountain Valley, California, 92708
Cara Therapeutics Study Site
Fresh Meadows, New York, 11365
Cara Therapeutics Study Site
Gallup, New Mexico, 87301
Cara Therapeutics Study Site
Great Neck, New York, 11021
Cara Therapeutics Study Site
Greenville, Texas, 75402
Cara Therapeutics Study Site
Hampton, Virginia, 23666
Cara Therapeutics Study Site
Hartford, Connecticut, 06112
Cara Therapeutics Study Site
Hialeah, Florida, 33016
Cara Therapeutics Study Site
Homewood, Alabama, 35209
Cara Therapeutics Study Site
Houston, Texas, 77054
Cara Therapeutics Study Site
Huntsville, Alabama, 35805
Cara Therapeutics Study Site
Kalamazoo, Michigan, 49007
Cara Therapeutics Study Site
Kansas City, Missouri, 64111
Cara Therapeutics
La Mesa, California, 91942
Cara Therapeutics Study Site
Las Vegas, Nevada, 89102
Cara Therapeutics Study Site
Las Vegas, Nevada, 89106
Cara Therapeutics Study Site
Lewisville, Texas, 75057
Cara Therapeutics Study Site
Long Beach, California, 90807
Cara Therapeutics Study Site
McAllen, Texas, 78503
Cara Therapeutics Study Site
McComb, Mississippi, 39648
Cara Therapeutics Study Site
Mesquite, Texas, 75150
Cara Therapeutics Study Site
Miami, Florida, 33125
Cara Therapeutics Study Site
Miami Gardens, Florida, 33169
Cara Therapeutics Study Site
Middlebury, Connecticut, 06762
Cara Therapeutics Study Site
Minneapolis, Minnesota, 55404
Cara Therapeutics Study Site
Ontario, California, 91762
Cara Therapeutics Study Site
Riverside, California, 92505
Cara Therapeutics Study Site
Roseburg, Oregon, 97471
Cara Therapeutics Study Site
Roseville, California, 95661
Cara Therapeutics Study Site
Roseville, Michigan, 48066
Cara Therapeutics Study Site
San Antonio, Texas, 78207
Cara Therapeutics Study Site
San Diego, California, 92111
Cara Therapeutics Study Site
San Dimas, California, 91773
Cara Therapeutics Study Site
Tampa, Florida, 33614
Cara Therapeutics Study Site
Tarzana, California, 91356
Cara Therapeutics Study Site
The Bronx, New York, 10461
Cara Therapeutics Study Site
Tupelo, Mississippi, 38801
Cara Therapeutics Study Site
Wauwatosa, Wisconsin, 53226
Cara Therapeutics Study Site
Waxahachie, Texas, 75165

Other trials in United States

About this study

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension

Read the detailed description

Double-blind Phase The Double-blind Phase of the study will consist of a Screening Visit, a 7-day Run-in Period, a 12 week Double-blind Treatment Period, and a 2-week Discontinuation Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 7 to 28 days prior to randomization to assess eligibility.

Open-label Extension Phase Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will have the option to receive open label CR845 for an additional 52 weeks. The Open-label Extension Phase will be comprised of the Open-label Treatment Period and the Follow-up Period.

The last dose of open-label study drug will be administered at the last dialysis visit on Week 52, or Early Termination. A final safety Follow up Visit will be conducted 7-10 days after the End of Treatment/Early Termination Visit.

Conditions: Uremic Pruritus
Being tested: CR845 0.5 mcg/kg, Placebo
Keywords: CR845, Pruritus, Chronic Itch, Itch, Itching, difelikefalin, Hemodialysis, Uremic Pruritus, Dialysis, CKD, CKD-associated pruritus, CKD-aP, ESRD (end stage renal disease), KALM, 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.

CR845 0.5 mcg/kgDrug
Also called CR845, Difelikefalin
IV medication delivered three times/week
PlaceboDrug
IV medication delivered three times/week

Study groups in NCT03422653
Study group	Role	What they receive
CR845 0.5mcg/kg	Active comparator	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: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12
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". LS means estimated percent, odds ratio and P value used a logistic regression model.
Measured: Week 12

Secondary outcomes (3)

Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in 5-D Itch Scale Score at the End of Week 12
The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. The 5-D Itch Scale has 5 questions; the total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse responses.
Measured: Baseline, Week 12
Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12
The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. The Skindex-10 has 10 questions; the total Skindex-10 score ranges from 0 to 60. A lower total score represents better quality of life.
Measured: Baseline, Week 12
Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥4 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12
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". LS means estimated percent, odds ratio and P value used a logistic regression model.
Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 201826 Mar 2020

First posted6 Feb 2018
Study start20 Feb 2018
Primary completion6 Apr 2019
Study completion26 Mar 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 (6)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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 378 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03422653
Sponsor's protocol ID: CR845-CLIN3102
Status last verified: Mar 2022
First submitted: 25 Jan 2018
Last updated: 26 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Fishbane SN, Block GA, Evenepoel P, Budden J, Morin I, Menzaghi F, Wen W, Lerma EV. Pruritus Severity and Serum Phosphate in CKD: A Post Hoc Analysis of Difelikefalin Studies. Kidney360. 2024 Sep 1;5(9):1270-1280. doi: 10.34067/KID.0000000000000520. Epub 2024 Jul 22.
PubMed 39037824
Weiner DE, Schaufler T, McCafferty K, Kalantar-Zadeh K, Germain M, Ruessmann D, Morin I, Menzaghi F, Wen W, Stander S. Difelikefalin improves itch-related sleep disruption in patients undergoing haemodialysis. Nephrol Dial Transplant. 2024 Jun 28;39(7):1125-1137. doi: 10.1093/ndt/gfad245.
PubMed 37968132
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
Topf J, Wooldridge T, McCafferty K, Schomig M, Csiky B, Zwiech R, Wen W, Bhaduri S, Munera C, Lin R, Jebara A, Cirulli J, Menzaghi F. Efficacy of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis of KALM-1 and KALM-2 Phase 3 Studies. Kidney Med. 2022 Jun 28;4(8):100512. doi: 10.1016/j.xkme.2022.100512. eCollection 2022 Aug.
PubMed 36016762
Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
PubMed 33283264
Fishbane S, Jamal A, Munera C, Wen W, Menzaghi F; KALM-1 Trial Investigators. A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus. N Engl J Med. 2020 Jan 16;382(3):222-232. doi: 10.1056/NEJMoa1912770. Epub 2019 Nov 8.
PubMed 31702883

Study at a glance

From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension
ClinicalTrials.gov ID: NCT03422653
Acronym / sponsor ID: CR845-CLIN3102
Conditions: Uremic Pruritus
Keywords: CR845, Pruritus, Chronic Itch, Itch, Itching, difelikefalin, Hemodialysis, Uremic Pruritus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 378 participants (actual)
Lead sponsor: Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 20 Feb 2018 (actual)
Primary completion: 6 Apr 2019 (actual)
Study completion: 26 Mar 2020 (actual)
First posted: 6 Feb 2018 (actual)
Results: Posted 26 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
CR845 0.5mcg/kg	Active comparator	Drug: CR845 0.5 mcg/kgIV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
Placebo	Placebo comparator	Drug: PlaceboIV Placebo administered after each dialysis session (3 times/week)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

To be eligible for inclusion into the Double-blind Phase of the study, a patient must meet the following criteria:
Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for at least 3 months prior to the start of screening;
Has at least 2 single-pool Kt/V measurements ≥1.2, or at least 2 urea reduction ratio measurements ≥65%, or 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% on different dialysis days during the 3 months period prior to screening;
Prior to randomization:
To be eligible for inclusion into the Open-label Extension Phase of the study, each patient will have to fulfill the additional key following criteria at the time of entry into the Open-label Extension Phase:

Key exclusion criteria (11 listed)

A patient will be excluded from the Double-blind Phase of the study if any of the following criteria are met:
Known noncompliance with dialysis treatment that in the opinion of the investigator would impede completion or validity of the study;
Scheduled to receive a kidney transplant during the study;
New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening;
Received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in 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: CR845, DifelikefalinIV medication delivered three times/week	Drug	CR845 0.5mcg/kg
PlaceboIV medication delivered three times/week	Drug	Placebo

Primary outcome

Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12
Time frame: Week 12
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". LS means estimated percent, odds ratio and P value used a logistic regression model.

3 secondary outcomes

Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in 5-D Itch Scale Score at the End of Week 12
Time frame: Baseline, Week 12
Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12
Time frame: Baseline, Week 12
Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥4 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12
Time frame: Week 12

Results and safety

Results posted to the registry on 26 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Double-blind CR845 0.5mcg/kg	189	162
Double-blind Placebo	189	170
Open-label CR845 0.5 mcg/kg	0	0

Primary outcome: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12

Time frame: Week 12. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	CR845 0.5mcg/kg n = 189	Placebo n = 189
Value	51.0 (42.9 to 58.9)	27.6 (20.2 to 36.6)

CR845 0.5mcg/kg vs Placebo: Odds Ratio (OR): 2.72 (95% CI 1.72 to 4.30), p <0.001, Cui, Hung, Wang

Population analysed: Data include one patient who had been randomly assigned to the placebo group and who withdrew from the trial before receiving the first dose of placebo.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Double-blind CR845 0.5mcg/kg	49 of 189 (25.9%)	40 of 189 (21.2%)	2 of 189
Double-blind Placebo	41 of 188 (21.8%)	30 of 188 (16%)	2 of 188
Open-label CR845 0.5 mcg/kg	167 of 313 (53.4%)	205 of 313 (65.5%)	22 of 313

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39037824Fishbane SN, Block GA, Evenepoel P, Budden J, Morin I, Menzaghi F, Wen W, Lerma EV. Pruritus Severity and Serum Phosphate in CKD: A Post Hoc Analysis of Difelikefalin Studies. Kidney360. 2024 Sep 1;5(9):1270-1280. doi: 10.34067/KID.0000000000000520. Epub 2024 Jul 22.
Derived from this study: PubMed 37968132Weiner DE, Schaufler T, McCafferty K, Kalantar-Zadeh K, Germain M, Ruessmann D, Morin I, Menzaghi F, Wen W, Stander S. Difelikefalin improves itch-related sleep disruption in patients undergoing haemodialysis. Nephrol Dial Transplant. 2024 Jun 28;39(7):1125-1137. doi: 10.1093/ndt/gfad245.
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.
Derived from this study: PubMed 36016762Topf J, Wooldridge T, McCafferty K, Schomig M, Csiky B, Zwiech R, Wen W, Bhaduri S, Munera C, Lin R, Jebara A, Cirulli J, Menzaghi F. Efficacy of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis of KALM-1 and KALM-2 Phase 3 Studies. Kidney Med. 2022 Jun 28;4(8):100512. doi: 10.1016/j.xkme.2022.100512. eCollection 2022 Aug.
Derived from this study: PubMed 33283264Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Derived from this study: PubMed 31702883Fishbane S, Jamal A, Munera C, Wen W, Menzaghi F; KALM-1 Trial Investigators. A Phase 3 Trial of Difelikefalin in Hemodialysis Patients with Pruritus. N Engl J Med. 2020 Jan 16;382(3):222-232. doi: 10.1056/NEJMoa1912770. Epub 2019 Nov 8.
Individual participant dataSharing planned: No

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.

Frédérique Menzaghi, PhD study director

Cara Therapeutics

57 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 CR845 0.5 mcg/kg in people with Uremic Pruritus, run by Cara Therapeutics, Inc. at 57 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 9 inclusion and 11 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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 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?

Yes. Results are posted in the registry (first posted 26 Apr 2022). 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?

Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12 (time frame: Week 12). 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 NCT03422653, which also lists 6 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 26 Apr 2022.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (9 listed)

Key exclusion criteria (11 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12

Adverse events

Research links

Related trials for Uremic Pruritus

Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12

Adverse events