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NCT03998163 Clinical Trial

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

Uremic Pruritus Clinical Trial

Official title:
An Open-Label, Multicenter Study to Evaluate the Safety and Effectiveness of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03998163
Other study ID # CR845-CLIN3105
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 6, 2019
Est. completion date March 6, 2020

Study information
Verified date September 2021
Source Cara Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Screening Period: The Screening Period includes a Screening Visit and a Run-In Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 21 days prior to the start of the Run-in Period. Patients will start the Run-in Period during the week prior to Treatment Period to complete eligibility verification. 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.

Recruitment information / eligibility
Status Completed
Enrollment 222
Est. completion date March 6, 2020
Est. primary completion date February 26, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Key Inclusion Criteria: To be eligible for inclusion into 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 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; Key Exclusion Criteria: 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CR845 0.5 mcg/kg
IV CR845 0.5 mcg/kg administered three times/week

Locations
Country Name City State
Czechia Cara Therapeutics Study Site Havlíckuv Brod
Czechia Cara Therapeutics Study Site Nové Mesto Na Morave
Czechia Cara Therapeutics Study Site Praha
Czechia Cara Therapeutics Study Site Sokolov
Hungary Cara Therapeutics Study Site Budapest
Hungary Cara Therapeutics Study Site 2 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
Poland Cara Therapeutics Study Site Ostroleka
Poland Cara Therapeutics Study Site Radom
Poland Cara Therapeutics Study Site Sochaczew
United States Cara Therapeutics Study Site Albany Georgia
United States Cara Therapeutics Study Site Austin Texas
United States Cara Therapeutics Study Site Boston Massachusetts
United States Cara Therapeutics Study Site Coral Gables Florida
United States Cara Therapeutics Study Site Denver Colorado
United States Cara Therapeutics Study Site Duncanville Texas
United States Cara Therapeutics Study Site Escondido California
United States Cara Therapeutics Study Site Fort Lauderdale Florida
United States Cara Therapeutics Study Site Great Neck New York
United States Cara Therapeutics Study Site Greenville Texas
United States Cara Therapeutics Study Site Hollywood Florida
United States Cara Therapeutics Study Site Kansas City Missouri
United States Cara Therapeutics Study Site Knoxville Tennessee
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 Mansfield Texas
United States Cara Therapeutics Study Site Mesquite Texas
United States Cara Therapeutics Study Site Miami Florida
United States Cara Therapeutics Study Site Middlebury Connecticut
United States Cara Therapeutics Study Site Minneapolis Minnesota
United States Cara Therapeutics Study Site Norwich Connecticut
United States Cara Therapeutics Study Site Philadelphia Pennsylvania
United States Cara Therapeutics Study Site Riverside California
United States Cara Therapeutics Study Site Roseville Michigan
United States Cara Therapeutics Study Site San Antonio Texas
United States Cara Therapeutics Study Site 2 San Antonio Texas
United States Cara Therapeutics Study Site 3 San Antonio Texas
United States Cara Therapeutics Study Site San Diego California
United States Cara Therapeutics Study Site Spartanburg South Carolina
United States Cara Therapeutics Study Site Tampa Florida
United States Cara Therapeutics Study Site 2 Tampa Florida
United States Cara Therapeutics Study Site Temple Texas
United States Cara Therapeutics Study Site Victorville California

Sponsors (1)
Lead Sponsor Collaborator
Cara Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Czechia,  Hungary,  Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With AEs. Assessed by monitoring of adverse events. Up to Follow-Up Visit (Week 13-14)
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