Solv Multi-Pass Hemodialysis System In-Center Clinical Study

NCT07216885 | Recruiting DMC FDA Device

• 1 other identifier: MDT22047
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  through study completion, an average of 1 year

Secondary Outcomes (10)

• Serious adverse events and all device and/or therapy related adverse events

  through study completion, an average of 1 year

• Uremic toxin profile

  through study completion, an average of 1 year

• Electrolyte balance and evaluate mineral metabolism

  through study completion, an average of 1 year

• Nutritional status

  through study completion, an average of 1 year

• Inflammation markers

  through study completion, an average of 1 year

Study Arms (1)

Solv Multi-Pass Hemodialysis System In-Center Subjects

EXPERIMENTAL

All subjects enrolled in the study and treated with the Solv Multi-Pass Hemodialysis System

Device: Solv Multi-Pass Hemodialysis System

Interventions

Solv Multi-Pass Hemodialysis System DEVICE

Solv Multi-Pass Hemodialysis System

Solv Multi-Pass Hemodialysis System In-Center Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mozarc Medical US LLC: lead

Study Sites (1)

Carolina Nephrology

Greenville, South Carolina, 29605, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sr. Clinical Research Director

CONTACT

877-211-1850; mike.serle@mozarcmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 15, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)