Clinical trial NCT04975880: Quanta Home Run Trial
Official title: A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: Hemodialysis
Lead sponsor: Quanta Dialysis Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2021-07-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Following enrollment participants will begin hemodialysis treatments on the SC+ machine on a prescription of four-hour treatments, three times per week or per facility standard for training within a hemodialysis facility for a minimum of 4 weeks.

During this time, both patients and caregivers will undergo extensive training and competency sign off on all aspects of safely administering hemodialysis treatment in the home. This 4 week period can be extended week by week to a maximum of 8 weeks until competency sign off is achieved.

Upon completion of training, a 1 week transition period will occur followed by the home hemodialysis phase (test phase) which consists of 8 weeks of treatments performed 4 times per week, 3.5 hours each treatment in the participant's home setting by the participant or their care partner.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Mean Standardized Weekly Kt/V (Efficacy)
timeFrame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
measure: Adverse Event Rate
timeFrame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
Secondary outcomes:
measure: Rate of Serious Adverse Events (SAEs) Per 100 Treatments.
timeFrame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Capital Nephrology Medical Group
state: California
city: San Diego
country: United States
facility: Home Dialysis Therapies of San Diego / UCSD
state: California
city: San Leandro
country: United States
facility: Satellite WellBound
state: California
city: San Mateo
country: United States
facility: Satellite - WellBound
state: California
city: Santa Rosa
country: United States
facility: Satellite - WellBound
state: California
city: Victorville
country: United States
facility: High Desert Nephrology Medical Group
state: California
city: Ocala
country: United States
facility: Ocala RKCHD At Home
state: Florida
city: Augusta
country: United States
facility: Southeastern Clinical Research Institute, LLC
state: Georgia
city: Indianapolis
country: United States
facility: DaVita Home Dialysis of Indianapolis
state: Indiana
city: New Hyde Park
country: United States
facility: New Hyde Park Dialysis Center
state: New York
city: Lancaster
country: United States
facility: Hypertension & Kidney Specialists
state: Pennsylvania
city: Houston
country: United States
facility: aQua Research Institute, LLC
state: Texas
city: Seattle
country: United States
facility: Northwest Kidney Centers
state: Washington
Study officials:
affiliation: Quanta Dialysis Technology
name: Paul Komenda, MD
role: STUDY_DIRECTOR
affiliation: University of Toronto
name: Christopher T Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: