Renal Failure
Conditions
Keywords
Hemodialysis
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.
Interventions
DEVICESC+ Hemodialysis System
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.
Sponsors
Quanta Dialysis Technologies Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Standardized Weekly Kt/V (Efficacy) | 4-8 weeks in the clinic training phase and 8 weeks during the home phase. | The primary effectiveness endpoint was the delivery of a mean standardized weekly Kt/V of greater than or equal to 2.1 in both the clinic phase and the home phase. The weekly standard Kt/V is used to assess dialysis effectiveness by taking into account the clearance provided by individual treatments and the number of times per week the participant treated. The weekly standardized Kt/V is calculated using K (clearance of urea), T (treatment time), and V (urea distribution volume). Current practice guidelines include achieving a minimum result of 2.1 with a target of achieving 2.3, with higher values representing better outcomes. A theoretical range for the minimum and maximum standardized weekly Kt/V does not exist. |
| Adverse Event Rate | 4-8 weeks in the clinic training phase and 8 weeks during the home phase. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Serious Adverse Events (SAEs) Per 100 Treatments. | 4-8 weeks in the clinic training phase and 8 weeks during the home phase. | Number of SAEs per 100 treatments occurring in the in-clinic portion of the study compared with those occurring in the home portion |
Countries
United States
Participant flow
Pre-assignment details
3 participants withdrew consent prior to beginning the clinic phase.
Participants by arm
| Arm | Count |
|---|---|
| Evaluable Population The Evaluable Population was defined as those participants who completed at least 75% of the treatments required by the protocol. The Evaluable Population of this study was 34 participants. | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Evaluable Population |
|---|---|
| Age, Continuous | 53.9 years STANDARD_DEVIATION 14.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 19 Participants |
| Vascular Access Type Central Line | 9 Participants |
| Vascular Access Type Fistula | 19 Participants |
| Vascular Access Type Graft | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 43 | 0 / 35 | 1 / 35 |
| other Total, other adverse events | 3 / 43 | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 5 / 43 | 0 / 35 | 8 / 35 |
Outcome results
Primary
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
Time frame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Clinic Training Phase | Adverse Event Rate | 6.3 Events per 100 treatments |
| Home Hemodialysis Phase | Adverse Event Rate | 5.2 Events per 100 treatments |
Primary
Mean Standardized Weekly Kt/V (Efficacy)
The primary effectiveness endpoint was the delivery of a mean standardized weekly Kt/V of greater than or equal to 2.1 in both the clinic phase and the home phase. The weekly standard Kt/V is used to assess dialysis effectiveness by taking into account the clearance provided by individual treatments and the number of times per week the participant treated. The weekly standardized Kt/V is calculated using K (clearance of urea), T (treatment time), and V (urea distribution volume). Current practice guidelines include achieving a minimum result of 2.1 with a target of achieving 2.3, with higher values representing better outcomes. A theoretical range for the minimum and maximum standardized weekly Kt/V does not exist.
Time frame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Clinic Training Phase | Mean Standardized Weekly Kt/V (Efficacy) | 2.4 Kt/V | Standard Deviation 0.04 |
| Home Hemodialysis Phase | Mean Standardized Weekly Kt/V (Efficacy) | 3.0 Kt/V | Standard Deviation 0.03 |
Secondary
Rate of Serious Adverse Events (SAEs) Per 100 Treatments.
Number of SAEs per 100 treatments occurring in the in-clinic portion of the study compared with those occurring in the home portion
Time frame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Clinic Training Phase | Rate of Serious Adverse Events (SAEs) Per 100 Treatments. | 0.6 Events per 100 treatments |
| Home Hemodialysis Phase | Rate of Serious Adverse Events (SAEs) Per 100 Treatments. | 0.8 Events per 100 treatments |