An Open-Label, Multicenter Study to Evaluate the Safety and Effectiveness of Intravenous CR845 in Hemodialysis Patients with Moderate-to-Severe Pruritus - CR845-CLIN3105

Cara Therapeutics, Inc.0 sites400 target enrollmentMay 30, 2019

Overview

No summary available.

Registry

who.int

Start Date

May 30, 2019

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Willing and able to provide written informed consent prior to participating in this study;
•2\. Able to communicate clearly with the Investigator and staff, able to understand the study procedures, and able and willing to comply with the study requirements, including providing written responses to questionnaires;
•3\. Male or female between 18 and 85 years of age, inclusive;
•4\. 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;
•Note 1: Patients who require an occasional additional dialysis treatment to manage fluid overload or electrolyte excesses may be enrolled as long as it is anticipated that no more than 1 such treatment will be required in any given week. Patients routinely on 4 dialyses a week will not be eligible.
•Note 2: Patients receiving in\-home hemodialysis may participate as long as they have switched to in\-center hemodialysis at least 2 weeks prior to screening and plan to remain on in\-center hemodialysis for the duration of the study.
•Note 3: Patients receiving alternate dialysis modalities such as nocturnal dialysis will not be eligible.
•5\. If female, is not pregnant or nursing during any period of the study;
•6\. If female:
•a. Is surgically sterile; or

•1\. Known noncompliance with dialysis treatment that in the opinion of the Investigator would impede completion or validity of the study;
•2\. Scheduled to receive a kidney transplant during the study;
•3\. Known history of allergic reaction to opiates, such as hives;
•Note: side effects related to the use of opioids, such as constipation or nausea, would not exclude patients from the study.
•4\. Hypersensitivity to the active substance or any of the excipients in the investigational products;
•5\. Has a concomitant disease or a history of any medical condition that, in the opinion of the Investigator, could pose undue risk to the patient, impede completion of the study procedures, or would compromise the validity of the study measurements, including, but not limited to:
•a. Known or suspected history of alcohol, narcotic, or other drug abuse, or substance dependence within 12 months prior to screening;
•b. Significant systolic or diastolic heart failure (eg, New York Heart Association Class IV congestive heart failure \[Appendix 1, Section 14\.1]);
•c. Severe mental illness or cognitive impairment (eg, dementia);
•d. Any other relevant acute or chronic medical or neuropsychiatric condition within 3 months prior to screening (eg, diagnosis of encephalopathy, coma,