NCT04395131

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

Clearum High Flux Hemodialyzer: Safety and Performance Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mozarc Medical US LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will compare performance to typical values obtained with commercially available dialyzers used for high flux hemodialysis and comparing the Clearum HS dialyzer to the baseline values of a control FX80 Dialyzer. 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. The sampling, reported in Table 1 below, will be done at mid-week sessions (pre and post session sampling) and consists of a blood draw for baseline dialysis with the FX80 weeks 1 and 2, or Clearum HS dialyzer at weeks 3, 5 and 8 for uremic toxins: urea, creatinine, phosphate, B2-microglobulin, albumin, sodium, potassium, calcium, magnesium, platelets and leucocytes, and platelets. In addition, a presession sample will be taken for coagulation parameter TAT, hematocrit and inflammatory markers IL6 and C reactive protein at baseline for FX80 at mid-week sessions during weeks 1 and 2 and during weeks 3, 5 and 8 for the Clearum HS dialyzer. Instantaneous B2M clearance sampling will be done at week 7 during the Clearum HS dialyzer phase and consists of a blood sample prior to the dialyzer and immediately after the dialyzer at two time points, 15-30 min and at 120-150 min, respectively. Blood rest will be done by comparing the dialyzer to a set of 5 illustrations and giving a score of 1 (worst) to 5 (best) that best correlates the dialyzer with the illustration, at the end of the dialysis session after blood has been returned to the patients (both FX80 and Clearum HS) on the sampling days. The patients will be treated for 2 weeks with a standard dialyzer (FX80) and an additional 6 weeks with the Clearum HS dialyzer (experimental period). Both hemodialyzers will be used for 3 times a week. Expected duration for the study including enrolment will be 3 months. The study duration will be approximately 3-4 months. Each patient will receive 6 hemodialysis sessions with FX80 and 18 sessions with Clearum HS hemodialyzer, and the treatment time will be between 3.5 and 4.5 hours

Conditions

• End-stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Clearum HF Hemodialyzer	the hemodialyzer will be used 3x week for 3.5-4.5 hours with a Qb of at least 350 ml/min

Timeline

• Start date: 2020-04-03
• Primary completion: 2020-08-14
• Completion: 2020-08-14
• First posted: 2020-05-20
• Last updated: 2026-04-01

Locations

1 site across 1 country: Germany