Clearum High Flux Hemodialyzer Used in Hemodialysis for Subjects With End-Stage Renal Disease

NCT04395131 | Completed

• 1 other identifier: SA0720191
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be a prospective, interventional, non-randomized, single-center study in 20 ESRD patients on hemodialysis. The study will compare performance of the Clearum HS dialyzer to typical values obtained with other commercially available high flux dialyzers. In addition, the Clearum HS dialyzer will be compared to a Fresenius FX80 dialyzer for a baseline (control) comparison. This will be a post-market study. The duration of the trial is 2 weeks for the FX80 control dialyzer + 6 weeks with the Clearum HS dialyzer used for 3x weekly high flux hemodialysis.

Conditions

End-stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Evaluate performance of small-solute (toxin) removal

  The primary objective of this study is to evaluate performance of small-solute (toxin) removal, represented by urea, under standard high flux hemodialysis conditions with a mean urea reduction ratio (URR) of 65% or greater.

  End of dialysis treatment

Secondary Outcomes (8)

• Adverse Events

  8 weeks, 3 sessions per week

• B2M reduction ratio

  5 sampling at mid-week session of week 1, 2, 3, 5 and 8

• Instantaneous clearance of B2M during specified time-points

  1 sampling at mid-week session of week 7

• Reduction ratio of albumin during hemodialysis

  5 sampling at mid-week session of week 1, 2, 3, 5 and 8

• Follow-up of CRP for patients treated with Clearum dialyzer

  Kinetic over 6 week period

Study Arms (1)

Clearum HF Dialysis Subjects

OTHER

All subjects enrolled in the study and treated with the Clearum HF hemodialyzer

Device: Clearum HF Hemodialyzer

Interventions

Clearum HF Hemodialyzer DEVICE

the hemodialyzer will be used 3x week for 3.5-4.5 hours with a Qb of at least 350 ml/min

Clearum HF Dialysis Subjects

Eligibility Criteria

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

You may qualify if:

• ESRD Patients aged 18 years or older
• Patients able to give informed consent (IC) and interested to participate in the study
• Stable (according to the investigator) on hemodialysis for more than 3 months with previous treatments of 3x weekly hemodialysis or hemodiafiltration
• Stable hemoglobin between 10 and 12 g/dl in the most recent two consecutive blood draws
• Stable anticoagulation and ESA regimen with no dosing modifications in the past 1 month
• Patients who have an adequate AVF or graft, capable of providing a blood flow rate of at least 300 mL/min according to sessions conducted in past month

You may not qualify if:

• Patients who have acute renal failure with the chance for recovery.
• Patients who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to PD within the next two months or who require single needle dialysis therapy.
• Pregnant and lactating women.
• Patients with a history of positive serology tests for Hepatitis B surface antigen, positive Hepatitis C total antibody, HIV and syphilis.
• Patients with known hemodynamic instability, anemia (Hgb \< 90 g/L), and/or severe bleeding risks secondary to coagulation disorders.
• Patients with active or ongoing infection per investigator's judgement.
• Patients with a history of solid tumors requiring anti-cancer therapy in the past or next 6 months or a life expectancy less than 1 year or patients with a history of a hematology neoplasm.
• Patients diagnosed with a NYHA Class IV congestive heart failure, or acute coronary syndrome and/or who have suffered a myocardial infarction within three months prior to the start of the study.
• Patients with a history of severe mental disorders.
• Patients who are currently participating or have previously participated in another interventional clinical trial in the past 4 weeks.
• Patients who have had an allergic response to polyarylethersulfone (PAES) or polysulfone membranes or have a history of poor tolerance to dialyzers with synthetic membranes.
• Patients with advanced liver, heart or pulmonary disease as judged by the Investigator
• Patients with any comorbidity possibly conflicting with the study purpose or procedures as judged by the Investigator.

Sponsors & Collaborators

• Mozarc Medical US LLC: lead

Study Sites (1)

DaVita Clinical Research Germany

Düsseldorf, D-40201, Germany

Location

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

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: April 30, 2020
• First Posted: May 20, 2020
• Study Start: April 3, 2020
• Primary Completion: August 14, 2020
• Study Completion: August 14, 2020
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)