CR845-CLIN3105: A Study to Evaluate the Safety and Effectiveness of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

NCT03998163 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CR845-CLIN3105
• Study Type: interventional
• Target: 222
• Locations: 4 countries
• Sites: 47

Brief Summary

This is a multicenter, open-label study to evaluate the safety and effectiveness of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes an up to 12-week Treatment Period.

Conditions

Uremic Pruritus

Keywords

Hemodialysis; Pruritus; Uremic Pruritus; Dialysis; CR845; Chronic Itch; CKD; CKD-associated pruritus; CKD-aP; ESRD (end stage renal disease); difelikefalin; Itch; Itching; KALM; Chronic Kidney Disease; Kidney failure, chronic; Kidney dysfunction; Generalized pruritus

Outcome Measures

Primary Outcomes (1)

• Number of Participants With AEs.

  Assessed by monitoring of adverse events.

  Up to Follow-Up Visit (Week 13-14)

Study Arms (1)

CR845 0.5mcg/kg

EXPERIMENTAL

IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)

Drug: CR845 0.5 mcg/kg

Interventions

CR845 0.5 mcg/kg DRUG

IV CR845 0.5 mcg/kg administered three times/week

Also known as: CR845, Difelikefalin

CR845 0.5mcg/kg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• A patient will be excluded from 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;
• 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.

Sponsors & Collaborators

• Cara Therapeutics, Inc.: lead

Study Sites (47)

Cara Therapeutics Study Site

Escondido, California, 92025, United States

Location

Cara Therapeutics Study Site

Riverside, California, 92505, United States

Location

Cara Therapeutics Study Site

San Diego, California, 92111, United States

Location

Cara Therapeutics Study Site

Victorville, California, 92395, United States

Location

Cara Therapeutics Study Site

Denver, Colorado, 80230, United States

Location

Cara Therapeutics Study Site

Middlebury, Connecticut, 06762, United States

Location

Cara Therapeutics Study Site

Norwich, Connecticut, 06382, United States

Location

Cara Therapeutics Study Site

Coral Gables, Florida, 33134, United States

Location

Cara Therapeutics Study Site

Fort Lauderdale, Florida, 33308, United States

Location

Cara Therapeutics Study Site

Hollywood, Florida, 33024, United States

Location

Cara Therapeutics Study Site

Miami, Florida, 33169, United States

Location

Cara Therapeutics Study Site 2

Tampa, Florida, 33614, United States

Location

Cara Therapeutics Study Site

Tampa, Florida, 33614, United States

Location

Cara Therapeutics Study Site

Albany, Georgia, 31701, United States

Location

Cara Therapeutics Study Site

Boston, Massachusetts, 02111, United States

Location

Cara Therapeutics Study Site

Roseville, Michigan, 48066, United States

Location

Cara Therapeutics Study Site

Minneapolis, Minnesota, 55404, United States

Location

Cara Therapeutics Study Site

Kansas City, Missouri, 64131, United States

Location

Cara Therapeutics Study Site

Las Vegas, Nevada, 89106, United States

Location

Cara Therapeutics Study Site 2

Las Vegas, Nevada, 89128, United States

Location

Cara Therapeutics Study Site

Great Neck, New York, 11021, United States

Location

Cara Therapeutics Study Site

Philadelphia, Pennsylvania, 19140, United States

Location

Cara Therapeutics Study Site

Spartanburg, South Carolina, 29302, United States

Location

Cara Therapeutics Study Site

Knoxville, Tennessee, 37920, United States

Location

Cara Therapeutics Study Site

Austin, Texas, 78751, United States

Location

Cara Therapeutics Study Site

Duncanville, Texas, 75137, United States

Location

Cara Therapeutics Study Site

Greenville, Texas, 75402, United States

Location

Cara Therapeutics Study Site

Mansfield, Texas, 76063, United States

Location

Cara Therapeutics Study Site

Mesquite, Texas, 75080, United States

Location

Cara Therapeutics Study Site 2

San Antonio, Texas, 78221, United States

Location

Cara Therapeutics Study Site

San Antonio, Texas, 78251, United States

Location

Cara Therapeutics Study Site 3

San Antonio, Texas, 78258, United States

Location

Cara Therapeutics Study Site

Temple, Texas, 76502, United States

Location

Cara Therapeutics Study Site

Havlíčkův Brod, Czechia

Location

Cara Therapeutics Study Site

Nové Město na Moravě, Czechia

Location

Cara Therapeutics Study Site

Prague, Czechia

Location

Cara Therapeutics Study Site

Sokolov, Czechia

Location

Cara Therapeutics Study Site 2

Budapest, Hungary

Location

Cara Therapeutics Study Site

Budapest, Hungary

Location

Cara Therapeutics Study Site

Dunaújváros, Hungary

Location

Cara Therapeutics Study Site

Kaposvár, Hungary

Location

Cara Therapeutics Study Site

Kistarcsa, Hungary

Location

Cara Therapeutics Study Site

Nyíregyháza, Hungary

Location

Cara Therapeutics Study Site

Szombathely, Hungary

Location

Cara Therapeutics Study Site

Ostrołęka, Poland

Location

Cara Therapeutics Study Site

Radom, Poland

Location

Cara Therapeutics Study Site

Sochaczew, Poland

Location

Related Publications (5)

• 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.

  PMID: 39037824 DERIVED

• 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.

  PMID: 38196014 DERIVED

• 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.

  PMID: 37968132 DERIVED

• 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.

  PMID: 36185706 DERIVED

• 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.

  PMID: 36039153 DERIVED

MeSH Terms

Conditions

Pruritus; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

difelikefalin

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Results Point of Contact

• Title: Frédérique Menzaghi, PhD
• Organization: Cara Therapeutics

clinicaltrials.gov@caratherapeutics.com

203-406-3700

Study Officials

• Frédérique Menzaghi, PhD

  Cara Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: June 26, 2019
• Study Start: May 6, 2019
• Primary Completion: February 26, 2020
• Study Completion: March 6, 2020
• Last Updated: October 15, 2021
• Results First Posted: October 15, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (33); CZ (4); HU (7); PL (3)