A Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus (KALM-1)
NCT ID: NCT03422653
Last Updated: 2022-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
378 participants
INTERVENTIONAL
2018-02-20
2020-03-26
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CR845 0.5mcg/kg
IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
CR845 0.5 mcg/kg
IV medication delivered three times/week
Placebo
IV Placebo administered after each dialysis session (3 times/week)
Placebo
IV medication delivered three times/week
Interventions
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CR845 0.5 mcg/kg
IV medication delivered three times/week
Placebo
IV medication delivered three times/week
Other Intervention Names
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Eligibility Criteria
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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
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Cara Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Frédérique Menzaghi, PhD
Role: STUDY_DIRECTOR
Cara Therapeutics
Locations
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Cara Therapeutics Study Site
Homewood, Alabama, United States
Cara Therapeutics Study Site
Huntsville, Alabama, United States
Cara Therapeutics Study Site
Bakersfield, California, United States
Cara Therapeutics Study Site 2
Beverly Hills, California, United States
Cara Therapeutics Study Site
Beverly Hills, California, United States
Cara Therapeutics Study Site
Chula Vista, California, United States
Cara Therapeutics Study Site
Corona, California, United States
Cara Therapeutics Study Site
Escondido, California, United States
Cara Therapeutics Study Site
Fountain Valley, California, United States
Cara Therapeutics
La Mesa, California, United States
Cara Therapeutics Study Site
Long Beach, California, United States
Cara Therapeutics Study Site
Ontario, California, United States
Cara Therapeutics Study Site
Riverside, California, United States
Cara Therapeutics Study Site
Roseville, California, United States
Cara Therapeutics Study Site
San Diego, California, United States
Cara Therapeutics Study Site
San Dimas, California, United States
Cara Therapeutics Study Site
Tarzana, California, United States
Cara Therapeutics Study Site
Denver, Colorado, United States
Cara Therapeutics Study Site
Bridgeport, Connecticut, United States
Cara Therapeutics Study Site
Hartford, Connecticut, United States
Cara Therapeutics Study Site
Middlebury, Connecticut, United States
Cara Therapeutics Study Site 1
Coral Springs, Florida, United States
Cara Therapeutics Study Site
Hialeah, Florida, United States
Cara Therapeutics Study Site
Miami, Florida, United States
Cara Therapeutics Study Site
Miami Gardens, Florida, United States
Cara Therapeutics Study Site
Tampa, Florida, United States
Cara Therapeutics Study Site
Kalamazoo, Michigan, United States
Cara Therapeutics Study Site
Roseville, Michigan, United States
Cara Therapeutics Study Site
Minneapolis, Minnesota, United States
Cara Therapeutics Study Site
Brookhaven, Mississippi, United States
Cara Therapeutics Study Site
McComb, Mississippi, United States
Cara Therapeutics Study Site
Tupelo, Mississippi, United States
Cara Therapeutics Study Site
Kansas City, Missouri, United States
Cara Therapeutics Study Site
Las Vegas, Nevada, United States
Cara Therapeutics Study Site
Las Vegas, Nevada, United States
Cara Therapeutics Study Site
Eatontown, New Jersey, United States
Cara Therapeutics Study Site
Albuquerque, New Mexico, United States
Cara Therapeutics Study Site
Gallup, New Mexico, United States
Cara Therapeutics Study Site
Fresh Meadows, New York, United States
Cara Therapeutics Study Site
Great Neck, New York, United States
Cara Therapeutics Study Site
The Bronx, New York, United States
Cara Therapeutics Study Site
Durham, North Carolina, United States
Cara Therapeutics Study Site
Canton, Ohio, United States
Cara Therapeutics Study Site
Roseburg, Oregon, United States
Cara Therapeutics Study Site
Chattanooga, Tennessee, United States
Cara Therapeutics Study Site
Dallas, Texas, United States
Cara Therapeutics Study Site
Duncanville, Texas, United States
Cara Therapeutics Study Site
Greenville, Texas, United States
Cara Therapeutics Study Site
Houston, Texas, United States
Cara Therapeutics Study Site
Lewisville, Texas, United States
Cara Therapeutics Study Site
McAllen, Texas, United States
Cara Therapeutics Study Site
Mesquite, Texas, United States
Cara Therapeutics Study Site
San Antonio, Texas, United States
Cara Therapeutics Study Site
Waxahachie, Texas, United States
Cara Therapeutics Study Site
Chesapeake, Virginia, United States
Cara Therapeutics Study Site
Hampton, Virginia, United States
Cara Therapeutics Study Site
Wauwatosa, Wisconsin, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CR845-CLIN3102
Identifier Type: -
Identifier Source: org_study_id
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