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

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.

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mississippi Medical Center, Jackson, Mississippi, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HemoCare™ Hemodialysis System

Device

The HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.

Primary outcomes

Number of Subjects With Safety Event

Time frame: 52 weeks

The Total Number of subjects having at least one Anticipated AE, Unanticipated AE, Device Related AE, Anticipated SAE, Unanticipated SAE and Device Related SAEs.

Sponsors and collaborators

Lead sponsor

Deka Research and Development

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2024
First posted: Dec 13, 2019
Registry last updated: Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed