Ensayos clínicos

Inclusion Criteria:

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

Exclusion Criteria:

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)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/19/23. Questions regarding updates should be directed to the study team contact.