Renal FailureNCT04975880
Quanta Home Run Trial
A study testing SC+ Hemodialysis System in people with Renal Failure, run by Quanta Dialysis Technologies Ltd at 13 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- SC+ Hemodialysis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 13 sitesUnited States
- Study dates
- 18 Nov 2021to 27 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Southeastern Clinical Research Institute, LLC
Augusta, Georgia, 30904
aQua Research Institute, LLC
Houston, Texas, 77058
DaVita Home Dialysis of Indianapolis
Indianapolis, Indiana, 46260
Hypertension & Kidney Specialists
Lancaster, Pennsylvania, 17604
New Hyde Park Dialysis Center
New Hyde Park, New York, 11040
Ocala RKCHD At Home
Ocala, Florida, 32724
Capital Nephrology Medical Group
Sacramento, California, 95825
Home Dialysis Therapies of San Diego / UCSD
San Diego, California, 92131
Satellite WellBound
San Leandro, California, 94577
Satellite - WellBound
San Mateo, California, 94403
Satellite - WellBound
Santa Rosa, California, 95407
Northwest Kidney Centers
Seattle, Washington, 98122
High Desert Nephrology Medical Group
Victorville, California, 92392
About this study
Official title: A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis
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.
Read the 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.
- Conditions
- Renal Failure
- Being tested
- SC+ Hemodialysis System
- Keywords
- Hemodialysis
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC+ Hemodialysis SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Treatments | Other | 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. Receives: Device: SC+ Hemodialysis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
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
Measured: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
Secondary outcomes (1)
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
Measured: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start18 Nov 2021
- Primary completion30 Oct 2023
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quanta Dialysis Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Komenda, MD, Study director, Quanta Dialysis TechnologyChristopher T Chan, MD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975880
- Sponsor's protocol ID
- 02-001
- Status last verified
- Dec 2024
- First submitted
- 14 Jul 2021
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Open-Label Assessment of Efficacy and Safety of Quanta SC+ for Home Hemodialysis
- ClinicalTrials.gov ID
- NCT04975880
- Acronym / sponsor ID
- 02-001
- Conditions
- Renal Failure
- Keywords
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Quanta Dialysis Technologies LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 26 Jul 2021 (actual)
- Results
- Posted 3 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis Treatments | Other | Device: SC+ Hemodialysis SystemAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (24 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC+ Hemodialysis SystemFollowing 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. | Device | Hemodialysis Treatments |
Primary outcome
Mean Standardized Weekly Kt/V (Efficacy)
Time frame: 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
Time frame: 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
1 secondary outcome
Rate of Serious Adverse Events (SAEs) Per 100 Treatments.
Time frame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Komenda, MD study director
Quanta Dialysis Technology
Christopher T Chan, MD principal investigator
University of Toronto
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SC+ Hemodialysis System in people with Renal Failure, run by Quanta Dialysis Technologies Ltd at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Standardized Weekly Kt/V (Efficacy) (time frame: 4-8 weeks in the clinic training phase and 8 weeks during the home phase.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.