Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to determine non-inferiority in safety and efficacy when Quanta SC+ is used in the self-care home environment compared to a hemodialysis facility.

Official Title

A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis

Details

This clinical trial is being conducted to evaluate the Quanta SC+ hemodialysis System for home use by patients with established kidney failure. A dialysis prescription of 3 sessions per week, 4 hours per session, or facility standard will be provided during the in-clinic training period, followed by the home period with a dialysis prescription of 4 sessions per week, 3.5 hours per session.

Keywords

Renal Failure, Hemodialysis, Renal Insufficiency, SC+ Hemodialysis System

Eligibility

You can join if…

Open to people ages 18-80

  1. Provision of a written informed consent form signed by the participant
  2. Age between 18 and 80 years at time of enrollment
  3. A care partner must be available for training on SC+ and to be present in the home during all home hemodialysis sessions
  4. Participants should be either receiving regular, facility-based hemodialysis therapy for at least 90 days, or in the case of peritoneal patients transitioning to hemodialysis, at least 90 days, or performing home dialysis (with any frequency) for at least 90 days and willing to return to facility for purpose of study, and should be clinically stable and deemed suitable for home dialysis in the opinion of the principal investigator
  5. Willing to accept a dialysis prescription of 3 sessions per week, 4 hours each session or facility standard during in-clinic visits; 4 sessions, 3.5 hours each session during in-home sessions
  6. In the opinion of the Investigator, participant has well-functioning and stable vascular access (tunneled, central venous catheter, arteriovenous fistula, or graft) that allows a blood flow of at least 300 ml/min
  7. Home environment is adequate to ensure that appropriate electrical connections and water supply necessary for the use and storage of the device as assessed by Quanta prior to subject C1 visit. Also ensure that cellular signal and/or WIFI capacity is adequate.
  8. Participant or care partner are capable of understanding the nature of procedures and requirements of the study protocol and of home-based hemodialysis, and are willing and capable of complying with protocol and returning to treatment center as stated in protocol
  9. Participant or care partner are capable of being trained to use the machine and troubleshoot should an alarm situation occur

    10. In the opinion of the treating physician, the subject is able to participate in the

    trial in terms of social factors and personal functioning

    11. Acceptable physical ability of the participant and/or care partner to perform the

    hemodialysis treatment at home

    12. Financial coverage for treatment costs by Medicare, Medicaid, private insurance, or

    other arrangement acceptable to participant

You CAN'T join if...

  1. Pregnant or trying to become pregnant (women of childbearing potential must use medically accepted contraceptive measures)
  2. Predicted life expectancy of less than 12 months from first study procedure
  3. Major cardiovascular adverse event in the 3 months prior to screening
  4. Fluid overload due to intractable ascites secondary to liver cirrhosis
  5. Uncontrolled or unstable blood pressure (systolic BP outside the range 90 to 180 mmHg)
  6. Unstable coronary artery disease
  7. New York Class III or IV heart failure, or ejection fraction less than 30%
  8. Participation in other clinical studies that may interfere with the current protocol
  9. Known problems with coagulation

    10. Active, life-threatening, rheumatologic disease. 11. Hematocrit less than 28% at enrollment 12. Hemoglobin less than 9 g/dL at enrollment 13. Suffering from active severe infection 14. Seroreactive for hepatitis B surface antigen 15. Suffering from active malignancy with expected deteriorating course within 6-12 months 16. History of severe reactions to dialyzer membrane material 17. Expected to receive an organ transplant during the course of the study 18. Have dementia or inability to understand procedures 19. Lack an ability for self-care 20. Are non-adherent to their current dialysis treatments 21. Experience intra-dialytic hypotension defined as a decrease in systolic blood pressure

    of greater than or equal to 20 mmHg or a decrease in mean arterial pressure of greater than or equal to 10 mmHg provided that the decrease is associated with clinical events (symptoms) and the need for an intervention (ultrafiltration turned off, bolus of fluid) in 3 of 5 previous treatments

    22. Is intolerant to heparin 23. Considered in the investigator's opinion to be clinically unstable for any other

    reason

    24. Undergoing outpatient dialysis for the treatment of acute kidney injury (AKI)

Locations

  • Home Dialysis Therapies of San Diego / UCSD
    San Diego California 92131 United States
  • High Desert Nephrology Medical Group
    Victorville California 92392 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Quanta Dialysis Technologies Ltd
ID
NCT04975880
Study Type
Interventional
Participants
About 46 people participating
Last Updated