NCT01722695

Performance Comparison of Revaclear With Larger Dialyzer

HD Performance Comparison of Revaclear 200 and Revaclear 400 With Larger-surface Competitor Dialyzers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to show equivalent performance of the Revaclear dialyzer when compared to a dialyzer with larger membrane surface area. Study design: open, randomized, cross-over, multicentric, controlled prospective Medical devices: Revaclear 200 versus FX 60 or Revaclear 400 versus FX 100, depending on patient needs Patients/sample size: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by hemodialysis for one week (3 dialysis sessions) with Revaclear dialyzers and one week (3 dialysis sessions) with FX dialyzers. Objectives: intraindividual comparison of dialysis dose; reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin; albumin loss Primary variable: dialysis dose Kt/V urea Secondary variable: reduction rates and total removal of urea, phosphate, creatinine and ß2-microglobulin Safety variable: albumin loss, blood count

Conditions

• Renal Failure Chronic Requiring Hemodialysis

Interventions

Type	Name	Description
OTHER	Dialyzer comparison	Each patient is treated by hemodialysis for one week (3 sessions) with each dialyzer type (Revaclear or FX). The order of dialyzers used will be randomly assigned to the patient at randomization.

Timeline

• Start date: 2012-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-11-07
• Last updated: 2025-03-13

Locations

2 sites across 1 country: Austria