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
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Pruritus
• Uremic Pruritus

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)