An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System

An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System for Home Hemodialysis Prior to Market Authorization

This study is designed to monitor and assess the safety of continued access to the HemoCare™ Hemodialysis System used during the review of the pre-market notifications for the devices in the HemoCare™ Hemodialysis System.

Inclusion Criteria:

• Completed DEKA Protocol DKPL 00057 001 and are qualified to enter the study based on the assessment of the Investigator.
• Are willing to comply and capable of complying with the study requirements for therapy with the HemoCare™ Hemodialysis System.
• Have a trained study care partner able to support subject for all at-home study treatments.
• Subject and care partner can read and understand English and provide written informed consent.
• Have a stable functioning vascular access as judged by the treating physician.

Exclusion Criteria:

• Have a current self-reported pregnancy or are actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study.
• Have any any other clinically significant medical disease or condition or subject responsibility that, in the Investigator's opinion, may interfere with a subject's (and/or care partner's) ability to give informed consent, adhere to the protocol, interfere with assessment of the investigational product (IP), or serve as a contraindication to the subject's participation in the study.
• Have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide informed consent and/or comply with study procedures.
• Are participating or planning to participate in any other interventional studies except DKPL-00057-001.