End Stage Renal Disease
Conditions
Brief 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. 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.
Interventions
DEVICESolv Multi-Pass Hemodialysis System
Solv Multi-Pass Hemodialysis System
Sponsors
Mozarc Medical US LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious adverse events and all device and/or therapy related adverse events | through study completion, an average of 1 year | 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 |
| Uremic toxin profile | through study completion, an average of 1 year | Characterize uremic toxin profile of urea, β-2 microglobulin and myoglobin |
| Electrolyte balance and evaluate mineral metabolism | through study completion, an average of 1 year | Verify electrolyte balance and evaluate mineral metabolism by characterizing pre-post session sodium, chloride, potassium, calcium, magnesium, bicarbonate, phosphate and glucose |
| Nutritional status | through study completion, an average of 1 year | Evaluate nutritional status by characterizing pre-post session albumin and change in body mass index (BMI) |
| Inflammation markers | through study completion, an average of 1 year | Assess inflammation markers by characterizing pre-session values of C-reactive protein (CRP) |
| Volume of UF removed | through study completion, an average of 1 year | 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 |
| Use of intradialytic medications | through study completion, an average of 1 year | Summarize the use of intradialytic anticoagulants and erythropoietin, phosphate binders and iron doses |
| Patient-reported outcome measures with KDQOL-36 | through study completion, an average of 1 year | 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 |
| Patient-reported outcome measures with Dialysis Recovery Time Questionnaire | through study completion, an average of 1 year | 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. |
| User Experience with Solv | through study completion, an average of 1 year | 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. |
Countries
United States
Outcome results
None listed