Clinical Performance of the Nipro ELISIO HX Medium Cut-Off Dialyzer

Phase 4

• Conditions: N18.5; Chronic kidney disease, stage 5

• Registration Number: DRKS00026806
• Lead Sponsor: eXcorLab GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-08
• Study Completion: 2021-12-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Age = 18 years
• End-stage kidney disease
• Chronic hemodialysis treatment for more than three months
• Hematocrit = 30 %
• Stable anticoagulation and erythropoietin regimen
• No vascular access-related problems (A/V-fistula or bi-flow catheter)
• No ongoing infection
• Signed informed consent form

Exclusion Criteria

• Inclusion criteria not met
• Known HIV infection.
• Pregnancy
• Unstable clinical condition (e.g., cardiac or vascular instability)
• Life expectancy less than 12 months
• Known coagulation problems
• Participation in another study interfering with the planned trial

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Removal of the solutes urea, creatinine, phosphate, beta-2-microglobulin, myoglobin, IL6, TNF-alpha, kappa and lambda light chains during hemodialysis

Secondary Outcome Measures

Name	Time	Method
Albumin loss into dialysate during hemodialysis