Quanta Home Run Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Renal Failure

Intervention / Treatment
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* Device: SC+ Hemodialysis System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of a written informed consent form signed by the participant Age between 18 and 80 years at time of enrollment A care partner must be available for training on SC+ and to be present in the home during all home hemodialysis sessions 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 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 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 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. 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 Participant or care partner are capable of being trained to use the machine and troubleshoot should an alarm situation occur In the opinion of the treating physician, the subject is able to participate in the trial in terms of social factors and personal functioning Acceptable physical ability of the participant and/or care partner to perform the hemodialysis treatment at home Financial coverage for treatment costs by Medicare, Medicaid, private insurance, or other arrangement acceptable to participant Exclusion Criteria: Pregnant or trying to become pregnant (women of childbearing potential must use medically accepted contraceptive measures) Predicted life expectancy of less than 12 months from first study procedure Major cardiovascular adverse event in the 3 months prior to screening Fluid overload due to intractable ascites secondary to liver cirrhosis Uncontrolled or unstable blood pressure (systolic BP outside the range 90 to 180 mmHg) Unstable coronary artery disease New York Class III or IV heart failure, or ejection fraction less than 30% Participation in other clinical studies that may interfere with the current protocol Known problems with coagulation Active, life-threatening, rheumatologic disease. Hematocrit less than 28% at enrollment Hemoglobin less than 9 g/dL at enrollment Suffering from active severe infection Seroreactive for hepatitis B surface antigen Suffering from active malignancy with expected deteriorating course within 6-12 months History of severe reactions to dialyzer membrane material Expected to receive an organ transplant during the course of the study Have dementia or inability to understand procedures Lack an ability for self-care Are non-adherent to their current dialysis treatments 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 Is intolerant to heparin Considered in the investigator's opinion to be clinically unstable for any other reason Undergoing outpatient dialysis for the treatment of acute kidney injury (AKI)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hemodialysis Treatments<br>All subjects will receive hemodialysis treatments using the SC+ machine for all phases of the trial including in-clinic training, transition, and in the home setting. | Device: SC+ Hemodialysis System<br>* Following the in-clinic training phase and one week transition, the intervention of self or care partner hemodialysis delivered in the home setting will occur for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Standardized Weekly Kt/V (Efficacy) | Mean standardized weekly Kt/V greater than or equal to 2.1, using a hemodialysis prescription of 4 sessions per week for 3.5 hours per session, measured for dialysis delivered during the home portion of the study. | 8 weeks per period | 
| Adverse Event Rate | Adverse event rate: the number of adverse events per 100 treatments that occurred during the study, as defined by: Serious adverse event (SAE) Allergic reaction: type A, anaphylactoid or type B dialyzer reactions to dialyzer, blood tubing, or chemical disinfectant. Blood loss: resulting in hemodynamic compromise that led to death, transfusion, or fluid resuscitation with greater than 1 liter of crystalloid IV fluids. Hemolytic reaction: due to disinfectant exposure, dialysate temperature, mechanical failure, or other device related causes. Infection: related to hemodialysis catheter, its tunnel or exit site, arteriovenous fistula (AVF), or arteriovenous graft (AVG). Intradialytic event: a significant clinical event such as loss of consciousness, cardiac arrest, or seizure caused by device failure. Vascular access complication Pyrogenic reaction Intradialytic hypotension | 8 weeks per period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of SAEs and device-related SAEs | Number of SAEs per 100 treatments occurring in the in-clinic portion of the study compared with those occurring in the home portion Number of device-related SAEs per 100 treatments in the in-clinic portion of the study compared with those occurring in the home portion Number of adverse events per 100 treatments occurring in the in-clinic portion of the study compared with those occurring in the home portion Additional adverse events of special interest: Air in blood tubing that cannot be resolved through usual procedure 30 minutes post dialysis elevated systolic blood pressure > 180 mmHg or low systolic blood pressure < 90 mmHg on two consistent treatments Significantly elevated (<100 mmHg or > 250 mmHg) arterial or venous pressures in 3 consecutive sessions Specific hematology laboratory values will be collected and compared to target ranges from clinical practice guidelines. | 8 weeks per period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis