CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
NCT ID: NCT03998163
Last Updated: 2021-10-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
222 participants
INTERVENTIONAL
2019-05-06
2020-03-06
Brief Summary
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Detailed Description
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Treatment Period: All scheduled study visits during the Treatment Period will be conducted on dialysis days. Patients will be administered CR845 as an IV bolus after the end of their dialysis during a Treatment Period of up to 12 weeks so that each patient will receive CR845 3 times weekly for a total of up to 36 doses. End of treatment (EOT) is defined as the first day of dialysis following the last dose of drug. The EOT procedures will be conducted on the dialysis visit following the last dose of study drug.
Follow-up Visit: A final safety Follow up Visit will be conducted 7-10 days after the EOT/Early Termination Visit.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
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 CR845 0.5 mcg/kg administered three times/week
Interventions
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CR845 0.5 mcg/kg
IV CR845 0.5 mcg/kg administered 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 Treatment:
* Has completed at least 3 Worst Itching Intensity NRS questionnaires from the start of the Run-in Period up to and including the pre-dose assessment on Day 1;
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;
* New or change of prescription for opioids, gabapentin, or pregabalin within 14 days prior to screening;
* Received another investigational drug within 30 days or five half-lives (whichever is longer) prior to the start of dosing or is planning to participate in another interventional clinical study while enrolled in this study;
* Has pruritus only during the dialysis session (by patient report);
* Is receiving ongoing ultraviolet B treatment and/or anticipates receiving such treatment during the study;
* Participated in a previous clinical study with CR845.
18 Years
85 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
Escondido, California, United States
Cara Therapeutics Study Site
Riverside, California, United States
Cara Therapeutics Study Site
San Diego, California, United States
Cara Therapeutics Study Site
Victorville, California, United States
Cara Therapeutics Study Site
Denver, Colorado, United States
Cara Therapeutics Study Site
Middlebury, Connecticut, United States
Cara Therapeutics Study Site
Norwich, Connecticut, United States
Cara Therapeutics Study Site
Coral Gables, Florida, United States
Cara Therapeutics Study Site
Fort Lauderdale, Florida, United States
Cara Therapeutics Study Site
Hollywood, Florida, United States
Cara Therapeutics Study Site
Miami, Florida, United States
Cara Therapeutics Study Site 2
Tampa, Florida, United States
Cara Therapeutics Study Site
Tampa, Florida, United States
Cara Therapeutics Study Site
Albany, Georgia, United States
Cara Therapeutics Study Site
Boston, Massachusetts, United States
Cara Therapeutics Study Site
Roseville, Michigan, United States
Cara Therapeutics Study Site
Minneapolis, Minnesota, United States
Cara Therapeutics Study Site
Kansas City, Missouri, United States
Cara Therapeutics Study Site
Las Vegas, Nevada, United States
Cara Therapeutics Study Site 2
Las Vegas, Nevada, United States
Cara Therapeutics Study Site
Great Neck, New York, United States
Cara Therapeutics Study Site
Philadelphia, Pennsylvania, United States
Cara Therapeutics Study Site
Spartanburg, South Carolina, United States
Cara Therapeutics Study Site
Knoxville, Tennessee, United States
Cara Therapeutics Study Site
Austin, Texas, United States
Cara Therapeutics Study Site
Duncanville, Texas, United States
Cara Therapeutics Study Site
Greenville, Texas, United States
Cara Therapeutics Study Site
Mansfield, Texas, United States
Cara Therapeutics Study Site
Mesquite, Texas, United States
Cara Therapeutics Study Site 2
San Antonio, Texas, United States
Cara Therapeutics Study Site
San Antonio, Texas, United States
Cara Therapeutics Study Site 3
San Antonio, Texas, United States
Cara Therapeutics Study Site
Temple, Texas, United States
Cara Therapeutics Study Site
Havlíčkův Brod, , Czechia
Cara Therapeutics Study Site
Nové Město na Moravě, , Czechia
Cara Therapeutics Study Site
Prague, , Czechia
Cara Therapeutics Study Site
Sokolov, , Czechia
Cara Therapeutics Study Site 2
Budapest, , Hungary
Cara Therapeutics Study Site
Budapest, , Hungary
Cara Therapeutics Study Site
Dunaújváros, , Hungary
Cara Therapeutics Study Site
Kaposvár, , Hungary
Cara Therapeutics Study Site
Kistarcsa, , Hungary
Cara Therapeutics Study Site
Nyíregyháza, , Hungary
Cara Therapeutics Study Site
Szombathely, , Hungary
Cara Therapeutics Study Site
Ostrołęka, , Poland
Cara Therapeutics Study Site
Radom, , Poland
Cara Therapeutics Study Site
Sochaczew, , Poland
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.
Fotheringham J, Guest J, Latus J, Lerma E, Morin I, Schaufler T, Soro M, Stander S, Zeig S. Impact of Difelikefalin on the Health-Related Quality of Life of Haemodialysis Patients with Moderate-To-Severe Chronic Kidney Disease-Associated Pruritus: A Single-Arm Intervention Trial. Patient. 2024 Mar;17(2):203-213. doi: 10.1007/s40271-023-00668-1. Epub 2024 Jan 9.
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.
Weiner DE, Vervloet MG, Walpen S, Schaufler T, Munera C, Menzaghi F, Wen W, Bhaduri S, Germain MJ; trial investigators. Safety and Effectiveness of Difelikefalin in Patients With Moderate-to-Severe Pruritus Undergoing Hemodialysis: An Open-Label, Multicenter Study. Kidney Med. 2022 Aug 24;4(10):100542. doi: 10.1016/j.xkme.2022.100542. eCollection 2022 Oct.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CR845-CLIN3105
Identifier Type: -
Identifier Source: org_study_id