CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
NCT ID: NCT03636269
Last Updated: 2022-04-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
473 participants
INTERVENTIONAL
2018-07-17
2020-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
NCT03998163
Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
NCT02858726
Extension Study to Evaluate IV CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
NCT03281538
Safety and Pharmacokinetics of IV CR845 in Hemodialysis Patients, and Its Efficacy in Patients With Uremic Pruritus
NCT02229929
A Study to Evaluate the Safety and Efficacy of CR845 in Chronic Kidney Disease Patients With Moderate-to-Severe Pruritus
NCT03617536
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CR845 0.5mcg/kg
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg
IV CR845 0.5 mcg/kg administered three times/week
Placebo
IV Placebo administered after each dialysis session (3 times/week)
Placebo
IV placebo administered three times/week
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CR845 0.5 mcg/kg
IV CR845 0.5 mcg/kg administered three times/week
Placebo
IV placebo administered three times/week
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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.
* 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;
Exclusion Criteria
* 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);
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cara Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Frédérique Menzaghi, PhD
Role: STUDY_DIRECTOR
Cara Therapeutics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cara Therapeutics Study Site
Chula Vista, California, United States
Cara Therapeutics Study Site
Fountain Valley, California, United States
Cara Therapeutics Study Site
Northridge, California, United States
Cara Therapeutics Study Site
Riverside, California, United States
Cara Therapeutics Study Site 2
San Dimas, California, United States
Cara Therapeutics Study Site
San Dimas, California, United States
Cara Therapeutics Study Site
Westminster, Colorado, United States
Cara Therapeutics Study Site
Hialeah, Florida, United States
Cara Therapeutics Study Site
Miami Gardens, Florida, United States
Cara Therapeutics Study Site
Orlando, Florida, United States
Cara Therapeutics Study Site
Athens, Georgia, United States
Cara Therapeutics Study Site
Macon, Georgia, United States
Cara Therapeutics Study Site
Baton Rouge, Louisiana, United States
Cara Therapeutics Study Site
Brockton, Massachusetts, United States
Cara Therapeutics Study Site
Kalamazoo, Michigan, United States
Cara Therapeutics Study Site
Roseville, Michigan, United States
Cara Therapeutics Study Site
Saint Clair, Michigan, United States
Cara Therapeutics Study Site
Tupelo, Mississippi, United States
Cara Therapeutics Study Site
St Louis, Missouri, United States
Cara Therapeutics Study Site
Clifton, New Jersey, United States
Cara Therapeutics Study Site
Somerville, New Jersey, United States
Cara Therapeutics Study Site
Albuquerque, New Mexico, United States
Cara Therapeutics Study Site
Long Island City, New York, United States
Cara Therapeutics Study Site
Austin, Texas, United States
Cara Therapeutics Study Site
Dallas, Texas, United States
Cara Therapeutics Study Site
McAllen, Texas, United States
Cara Therapeutics Study Site
San Antonio, Texas, United States
Cara Therapeutics Study Site
St. George, Utah, United States
Cara Therapeutics Study Site
Roanoke, Virginia, United States
Cara Therapeutics Study Site
Camperdown, New South Wales, Australia
Cara Therapeutics Study Site
Concord, New South Wales, Australia
Cara Therapeutics Study Site
Wahroonga, New South Wales, Australia
Cara Therapeutics Study Site
Westmead, New South Wales, Australia
Cara Therapeutics Study Site
Launceston, Tasmania, Australia
Cara Therapeutics Study Site
Clayton, Victoria, Australia
Cara Therapeutics Study Site
Heidelberg, Victoria, Australia
Cara Therapeutics Study Site
St Albans, Victoria, Australia
Cara Therapeutics Study Site
Adelaide, , Australia
Cara Therapeutics Study Site
Halifax, Nova Scotia, Canada
Cara Therapeutics Study Site
Oshawa, Ontario, Canada
Cara Therapeutics Study Site
Scarborough Village, Ontario, Canada
Cara Therapeutics Study Site
Toronto, Ontario, Canada
Cara Therapeutics Study Site
Montreal, Quebec, Canada
Cara Therapeutics Study Site
Frýdek-Místek, , Czechia
Cara Therapeutics Study Site
Prague, , Czechia
Cara Therapeutics Study Site
Düsseldorf, , Germany
Cara Therapeutics Study Site
Heilbronn, , Germany
Cara Therapeutics Study Site
Baja, , Hungary
Cara Therapeutics Study Site
Debrecen, , Hungary
Cara Therapeutics Study Site 2
Pécs, , Hungary
Cara Therapeutics Study Site
Pécs, , Hungary
Cara Therapeutics Study Site
Szeged, , Hungary
Cara Therapeutics Study Site
Székesfehérvár, , Hungary
Cara Therapeutics Study Site
Szigetvár, , Hungary
Cara Therapeutics Study Site
Auckland, , New Zealand
Cara Therapeutics Study Site
Hamilton, , New Zealand
Cara Therapeutics Study Site
New Plymouth, , New Zealand
Cara Therapeutics Study Site
Brodnica, , Poland
Cara Therapeutics Study Site
Brzeg, , Poland
Cara Therapeutics Study Site
Bydgoszcz, , Poland
Cara Therapeutics Study Site
Grójec, , Poland
Cara Therapeutics Study Site
Krakow, , Poland
Cara Therapeutics Study Site
Kwidzyn, , Poland
Cara Therapeutics Study Site 2
Lodz, , Poland
Cara Therapeutics Study Site
Lodz, , Poland
Cara Therapeutics Study Site
Nakło nad Notecią, , Poland
Cara Therapeutics Study Site
Olkusz, , Poland
Cara Therapeutics Study Site
Olsztyn, , Poland
Cara Therapeutics Study Site
Poznan, , Poland
Cara Therapeutics Study Site
Warsaw, , Poland
Cara Therapeutics Study Site
Wroclaw, , Poland
Cara Therapeutics Study Site
Zamość, , Poland
Cara Therapeutics Study Site
Żyrardów, , Poland
Cara Therapeutics Study Site
Daegu, , South Korea
Cara Therapeutics Study Site 2
Daegu, , South Korea
Cara Therapeutics Study Site
Daejeon, , South Korea
Cara Therapeutics Study Site
Goyang-si, , South Korea
Cara Therapeutics Study Site
Guri-si, , South Korea
Cara Therapeutics Study Site
Seogu, , South Korea
Cara Therapeutics Study Site 2
Seoul, , South Korea
Cara Therapeutics Study Site 3
Seoul, , South Korea
Cara Therapeutics Study Site
Seoul, , South Korea
Cara Therapeutics Study Site
Kaohsiung City, , Taiwan
Cara Therapeutics Study Site
New Taipei City, , Taiwan
Cara Therapeutics Study Site 2
Taipei, , Taiwan
Cara Therapeutics Study Site
Taipei, , Taiwan
Cara Therapeutics Study Site
Belfast, , United Kingdom
Cara Therapeutics Study Site
Ipswich, , United Kingdom
Cara Therapeutics Study Site
London, , United Kingdom
Cara Therapeutics Study Site
Londonderry, , United Kingdom
Cara Therapeutics Study Site
Nottingham, , United Kingdom
Cara Therapeutics Study Site
Westcliff-on-Sea, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CR845-CLIN3103
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.