End Stage Renal DiseaseNCT07216885
Solv Multi-Pass Hemodialysis System In-Center Clinical Study
A study testing Solv Multi-Pass Hemodialysis System in people with End Stage Renal Disease, run by Mozarc Medical US LLC at 1 site in United States.
Trial summary
Solv In-Center clinical study is a pre-market, prospective, multicenter, single arm, open-label clinical study. The patient population will include patients with kidney failure or insufficiency requiring hemodialysis and/or ultrafiltration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Solv Multi-Pass Hemodialysis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2026to 11 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects able and willing to give Informed Consent and interested to participate in the study
- Subject aged 18 years or older
- Subjects meets one of the following three conditions:
- End stage renal disease (ESRD) patients who have been adequately treated with maintenance HD and deemed stable, according to the investigator, for at least three months
- Incident end stage renal disease (ESRD) patients who have been prescribed HD therapy
- Subjects on peritoneal dialysis who require conversion to hemodialysis, according to the investigator
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- Subjects who have adequate access, capable of providing a blood flow rate of at least 300 mL/min
- Subject understands the nature of the procedures and the requirements of the study protocol
- Subject is willing and able to comply with the protocol requirements and return to the treatment center for all required treatments and clinical evaluations
Who cannot join
- Subjects with baseline dry weight of ≤ 60 kg or ≥ 110 kg
- Subjects with a documented history of non-compliance to scheduled hemodialysis sessions or clinic visits
- Subjects who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to peritoneal dialysis (PD) within the next two months or who require single needle dialysis therapy
- Subjects with unstable electrolytes or acid base balance, in the opinion of the investigator
- Subjects with any major surgery or major adverse cardiac event within 3 months of screening
- Subjects with hemodynamic instability, defined as repeated hypo/hypertension, in the past 30 days from screening
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- Subjects with active or ongoing infection, in the opinion of the Investigator
- Subjects with known Hepatitis B, C or HIV infection
- Subject with documented coagulation disorders, active or bleeding risk or who is intolerant to heparin
- Subjects who are currently participating or have previously participated in another interventional clinical trial in the past 4 weeks from screening
- Subjects with any comorbidities possibly conflicting with the study purpose or procedures, in the opinion of the Investigator
- Subjects who are pregnant or lactating or any patient with a childbearing potential who refuses to use medically acceptable means of contraception
- Subjects with an active, malignant disease and whose life expectancy is < 6 months, in the opinion of the investigator
- Subjects with a hemoglobin < 9 gm/dl in the past 30 days from screening
- Subjects with significant intradialytic hypotension in 30 days from screening
- Subjects with shock within 30 days from screening
- Subjects with active seizures in the last 6 months from screening
- Subjects with history of hemolytic anemia or thrombocytopenia
- Subjects with vascular access dysfunction (switching ports (reverse lines or catheter replacement) in 30 days prior to screening, multiple tPA (tissue plasminogen activator) administrations) or patient who has had a thrombectomy procedure within 30 days prior to screening
- Subjects with a documented history of congestive heart failure with symptoms consistent with NYHA Class III or IV, according to the investigator, or documented severe left ventricular dysfunction
- Subjects with fluid overload due to intractable ascites secondary to liver cirrhosis
- Subjects with active, life-threatening rheumatologic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Nephrology
Greenville, South Carolina, 29605
About this study
Solv In-Center clinical study is a pre-market, prospective, multicenter, single arm, open-label clinical study. The patient population will include patients with kidney failure or insufficiency requiring hemodialysis and/or ultrafiltration. Eligibility will be open to incident dialysis patients and patients currently receiving HD in an in-center environment. All vascular access types including AV-fistula, AV-graft, and tunneled hemodialysis catheters.
- Conditions
- End Stage Renal Disease
- Being tested
- Solv Multi-Pass Hemodialysis System
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solv Multi-Pass Hemodialysis SystemDevice
Solv Multi-Pass Hemodialysis System
| Study group | Role | What they receive |
|---|---|---|
| Solv Multi-Pass Hemodialysis System In-Center Subjects | Experimental | All subjects enrolled in the study and treated with the Solv Multi-Pass Hemodialysis System Receives: Device: Solv Multi-Pass Hemodialysis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Evaluate the number of serious device-related adverse events that occur during the In-Center Phase of the study, to confirm there are no additional risks associated with the Solv System implementation of sorbent-based HD.
Measured: through study completion, an average of 1 year
Primary Performance Endpoint
Evaluate the mean single pool (sp)Kt/V for subjects undergoing conventional In-Center HD with the Solv Multi-Pass Hemodialysis System during the eight-week study Phase.
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
Serious adverse events and all device and/or therapy related adverse events
Quantify all serious adverse events and all device and/or therapy related adverse events which occur during the Run-in and In-Center Phase, regardless of relationship to the Solv Multi-Pass Hemodialysis System or seriousness
Measured: through study completion, an average of 1 year
Uremic toxin profile
Characterize uremic toxin profile of urea, β-2 microglobulin and myoglobin
Measured: through study completion, an average of 1 year
Electrolyte balance and evaluate mineral metabolism
Verify electrolyte balance and evaluate mineral metabolism by characterizing pre-post session sodium, chloride, potassium, calcium, magnesium, bicarbonate, phosphate and glucose
Measured: through study completion, an average of 1 year
Nutritional status
Evaluate nutritional status by characterizing pre-post session albumin and change in body mass index (BMI)
Measured: through study completion, an average of 1 year
Inflammation markers
Assess inflammation markers by characterizing pre-session values of C-reactive protein (CRP)
Measured: through study completion, an average of 1 year
Volume of UF removed
Confirm that the volume of UF removed as indicated by the Solv System will be within 10% of target UF volume entered into the device per session, accounting for prescribed estimated dry weight, treatment time, and rinse back volume
Measured: through study completion, an average of 1 year
Use of intradialytic medications
Summarize the use of intradialytic anticoagulants and erythropoietin, phosphate binders and iron doses
Measured: through study completion, an average of 1 year
Patient-reported outcome measures with KDQOL-36
Quantify patient-reported outcome measures on KDQOL-36 questionnaire to assess patient quality of life and satisfaction, along with physicial and mental health. The KDQOL will be collected at baseline and IC- weeks 1, 4, and 8 for comparison
Measured: through study completion, an average of 1 year
Patient-reported outcome measures with Dialysis Recovery Time Questionnaire
Quantify patient-reported outcome measures on dialysis recovery time to assess amoujnt of time it takes for each subject to recover from a dialysis session. The DRT questionnaire will be collected at baseline and In-Center Weeks 1, 4, \& 8 for comparison.
Measured: through study completion, an average of 1 year
User Experience with Solv
Characterize the user experience via questionnaire (e.g., Solv set-up, recharging process, alarm management). The questionnaire will be provided to a sampling of users.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start13 Jan 2026
- Primary completion11 Sep 2026
- Study completion11 Sep 2026
Why it stopped: Due to funding the study has been stopped. All subjects enrolled have completed the follow-up and have exited the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mozarc Medical US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216885
- Sponsor's protocol ID
- MDT22047
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Solv Multi-Pass Hemodialysis System In-Center Clinical Study
- ClinicalTrials.gov ID
- NCT07216885
- Acronym / sponsor ID
- MDT22047
- Conditions
- End Stage Renal Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to funding the study has been stopped. All subjects enrolled have completed the follow-up and have exited the study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mozarc Medical US LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 11 Sep 2026 (actual)
- Study completion
- 11 Sep 2026 (actual)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Solv In-Center clinical study is a pre-market, prospective, multicenter, single arm, open-label clinical study. The patient population will include patients with kidney failure or insufficiency requiring hemodialysis and/or ultrafiltration. Eligibility will be open to incident dialysis patients and patients currently receiving HD in an in-center environment. All vascular access types including AV-fistula, AV-graft, and tunneled hemodialysis catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solv Multi-Pass Hemodialysis System In-Center Subjects | Experimental | Device: Solv Multi-Pass Hemodialysis SystemAll subjects enrolled in the study and treated with the Solv Multi-Pass Hemodialysis System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects able and willing to give Informed Consent and interested to participate in the study
- Subject aged 18 years or older
- Subjects meets one of the following three conditions:
- Subjects who have adequate access, capable of providing a blood flow rate of at least 300 mL/min
- Subject understands the nature of the procedures and the requirements of the study protocol
Key exclusion criteria (22 listed)
- Subjects with baseline dry weight of ≤ 60 kg or ≥ 110 kg
- Subjects with a documented history of non-compliance to scheduled hemodialysis sessions or clinic visits
- Subjects who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to peritoneal dialysis (PD) within the next two months or who require single needle dialysis therapy
- Subjects with unstable electrolytes or acid base balance, in the opinion of the investigator
- Subjects with any major surgery or major adverse cardiac event within 3 months of screening
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 |
|---|---|---|
| Solv Multi-Pass Hemodialysis SystemSolv Multi-Pass Hemodialysis System | Device | Solv Multi-Pass Hemodialysis System In-Center Subjects |
Primary outcome
Primary Safety Endpoint
Time frame: through study completion, an average of 1 year
Evaluate the number of serious device-related adverse events that occur during the In-Center Phase of the study, to confirm there are no additional risks associated with the Solv System implementation of sorbent-based HD.
Primary Performance Endpoint
Time frame: through study completion, an average of 1 year
Evaluate the mean single pool (sp)Kt/V for subjects undergoing conventional In-Center HD with the Solv Multi-Pass Hemodialysis System during the eight-week study Phase.
10 secondary outcomes
Serious adverse events and all device and/or therapy related adverse events
Time frame: through study completion, an average of 1 year
Uremic toxin profile
Time frame: through study completion, an average of 1 year
Electrolyte balance and evaluate mineral metabolism
Time frame: through study completion, an average of 1 year
Nutritional status
Time frame: through study completion, an average of 1 year
Inflammation markers
Time frame: through study completion, an average of 1 year
Volume of UF removed
Time frame: through study completion, an average of 1 year
Use of intradialytic medications
Time frame: through study completion, an average of 1 year
Patient-reported outcome measures with KDQOL-36
Time frame: through study completion, an average of 1 year
Patient-reported outcome measures with Dialysis Recovery Time Questionnaire
Time frame: through study completion, an average of 1 year
User Experience with Solv
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Due to funding the study has been stopped. All subjects enrolled have completed the follow-up and have exited the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solv Multi-Pass Hemodialysis System in people with End Stage Renal Disease, run by Mozarc Medical US LLC at 1 site 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 9 inclusion and 22 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: stopped early, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Due to funding the study has been stopped. All subjects enrolled have completed the follow-up and have exited the study.). Results are not available in the source record.
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?
Primary Safety Endpoint (time frame: through study completion, an average of 1 year). 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 1 Oct 2026.