Uremic PruritusPhase 3KALM-2NCT03636269
CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
A Phase 3 study testing CR845 0.5 mcg/kg in people with Uremic Pruritus, run by Cara Therapeutics, Inc. at 92 sites in 11 countries.
Trial summary
This is a multicenter, international 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 randomized, double-blind, placebo-controlled 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
- 473 participants
- Where
- 92 sitesin 11 countries
- Study dates
- 17 Jul 2018to 30 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
92 sites in 11 countries.
92 sites in 11 countries
United States29 sites
Cara Therapeutics Study Site
Albuquerque, New Mexico, 87109
Cara Therapeutics Study Site
Athens, Georgia, 30606
Cara Therapeutics Study Site
Austin, Texas, 78758
Cara Therapeutics Study Site
Baton Rouge, Louisiana, 70808
Cara Therapeutics Study Site
Brockton, Massachusetts, 02301
Cara Therapeutics Study Site
Chula Vista, California, 91910
Cara Therapeutics Study Site
Clifton, New Jersey, 07011
Cara Therapeutics Study Site
Dallas, Texas, 75228
Cara Therapeutics Study Site
Fountain Valley, California, 92708
Cara Therapeutics Study Site
Hialeah, Florida, 33012
Cara Therapeutics Study Site
Kalamazoo, Michigan, 49007
Cara Therapeutics Study Site
Long Island City, New York, 11106
Cara Therapeutics Study Site
Macon, Georgia, 31201
Cara Therapeutics Study Site
McAllen, Texas, 78503
Cara Therapeutics Study Site
Miami Gardens, Florida, 33169
Cara Therapeutics Study Site
Northridge, California, 91324
Cara Therapeutics Study Site
Orlando, Florida, 32810
Cara Therapeutics Study Site
Riverside, California, 92503
Cara Therapeutics Study Site
Roanoke, Virginia, 24014
Cara Therapeutics Study Site
Roseville, Michigan, 48066
Cara Therapeutics Study Site
Saint Clair, Michigan, 48081
Cara Therapeutics Study Site
San Antonio, Texas, 78207
Cara Therapeutics Study Site 2
San Dimas, California, 91773
Cara Therapeutics Study Site
San Dimas, California, 91773
Cara Therapeutics Study Site
Somerville, New Jersey, 08876
Cara Therapeutics Study Site
St Louis, Missouri, 63136
Cara Therapeutics Study Site
St. George, Utah, 84790
Cara Therapeutics Study Site
Tupelo, Mississippi, 38801
Cara Therapeutics Study Site
Westminster, Colorado, 80031
Poland16 sites
Cara Therapeutics Study Site
Brodnica
Cara Therapeutics Study Site
Brzeg
Cara Therapeutics Study Site
Bydgoszcz
Cara Therapeutics Study Site
Grójec
Cara Therapeutics Study Site
Krakow
Cara Therapeutics Study Site
Kwidzyn
Cara Therapeutics Study Site 2
Lodz
Cara Therapeutics Study Site
Lodz
Cara Therapeutics Study Site
Nakło nad Notecią
Cara Therapeutics Study Site
Olkusz
Cara Therapeutics Study Site
Olsztyn
Cara Therapeutics Study Site
Poznan
Cara Therapeutics Study Site
Warsaw
Cara Therapeutics Study Site
Wroclaw
Cara Therapeutics Study Site
Zamość
Cara Therapeutics Study Site
Żyrardów
Australia9 sites
Cara Therapeutics Study Site
Adelaide
Cara Therapeutics Study Site
Camperdown, New South Wales
Cara Therapeutics Study Site
Clayton, Victoria
Cara Therapeutics Study Site
Concord, New South Wales
Cara Therapeutics Study Site
Heidelberg, Victoria
Cara Therapeutics Study Site
Launceston, Tasmania
Cara Therapeutics Study Site
St Albans, Victoria
Cara Therapeutics Study Site
Wahroonga, New South Wales, 2076
Cara Therapeutics Study Site
Westmead, New South Wales
South Korea9 sites
Cara Therapeutics Study Site
Daegu, 41931
Cara Therapeutics Study Site 2
Daegu
Cara Therapeutics Study Site
Daejeon
Cara Therapeutics Study Site
Goyang-si
Cara Therapeutics Study Site
Guri-si
Cara Therapeutics Study Site
Seogu, 49201
Cara Therapeutics Study Site 2
Seoul
Cara Therapeutics Study Site 3
Seoul
Cara Therapeutics Study Site
Seoul
Hungary7 sites
Cara Therapeutics Study Site
Baja, 6500
Cara Therapeutics Study Site
Debrecen
Cara Therapeutics Study Site 2
Pécs
Cara Therapeutics Study Site
Pécs
Cara Therapeutics Study Site
Szeged, 6720
Cara Therapeutics Study Site
Székesfehérvár
Cara Therapeutics Study Site
Szigetvár
United Kingdom6 sites
Cara Therapeutics Study Site
Belfast
Cara Therapeutics Study Site
Ipswich
Cara Therapeutics Study Site
London
Cara Therapeutics Study Site
Londonderry
Cara Therapeutics Study Site
Nottingham
Cara Therapeutics Study Site
Westcliff-on-Sea
Canada5 sites
Cara Therapeutics Study Site
Halifax, Nova Scotia
Cara Therapeutics Study Site
Montreal, Quebec
Cara Therapeutics Study Site
Oshawa, Ontario
Cara Therapeutics Study Site
Scarborough Village, Ontario
Cara Therapeutics Study Site
Toronto, Ontario
Taiwan4 sites
Cara Therapeutics Study Site
Kaohsiung City
Cara Therapeutics Study Site
New Taipei City
Cara Therapeutics Study Site 2
Taipei
Cara Therapeutics Study Site
Taipei
New Zealand3 sites
Cara Therapeutics Study Site
Auckland
Cara Therapeutics Study Site
Hamilton
Cara Therapeutics Study Site
New Plymouth
Czechia2 sites
Cara Therapeutics Study Site
Frýdek-Místek
Cara Therapeutics Study Site
Prague
Germany2 sites
Cara Therapeutics Study Site
Düsseldorf
Cara Therapeutics Study Site
Heilbronn
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
This is a multicenter, international 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 randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.
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, and a 12-week Double-blind Treatment 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 last dose of open-label study drug will be administered at the last dialysis visit on Week 52, or Early Termination.
Follow-up Period: 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
- Hemodialysis, difelikefalin, CR845, Pruritus, Chronic Itch, Itch, Itching, 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 CR845 0.5 mcg/kg administered three times/week
PlaceboDrug
IV placebo administered three times/week
| 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)
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
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start17 Jul 2018
- Primary completion30 Mar 2020
- Study completion30 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 (5)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 473 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
- NCT03636269
- Sponsor's protocol ID
- CR845-CLIN3103
- Acronym
- KALM-2
- Status last verified
- Mar 2022
- First submitted
- 3 Aug 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 39037824Weiner 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 37968132Fishbane 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 36039153Topf 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 36016762Hercz 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
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
- NCT03636269
- Acronym / sponsor ID
- KALM-2 / CR845-CLIN3103
- Conditions
- Uremic Pruritus
- Keywords
- Hemodialysis, difelikefalin, CR845, Pruritus, Chronic Itch, Itch, Itching, Uremic Pruritus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Cara Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 17 Aug 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.
This is a multicenter, international 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 randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.
Detailed description
Double-blind Phase: The Double-blind Phase of the study will consist of a Screening Visit, a 7-day Run-in Period, and a 12-week Double-blind Treatment 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 last dose of open-label study drug will be administered at the last dialysis visit on Week 52, or Early Termination.
Follow-up Period: A final safety Follow up Visit will be conducted 7-10 days after the End of Treatment/Early Termination Visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, 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 CR845 0.5 mcg/kg administered three times/week | Drug | CR845 0.5mcg/kg |
| PlaceboIV placebo administered 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
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
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
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
Results and safety
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.
- 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
92 sites in 11 countries: 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 92 sites in 11 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 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 92 sites in United States, Poland, Australia, South Korea, Hungary and 6 more countries. 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 NCT03636269, which also lists 5 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.