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Performance Comparison of Revaclear With Larger Dialyzer — Revacom HD  

Renal Failure Chronic Requiring Hemodialysis Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01722695
Study type Interventional
Source Baxter Healthcare Corporation
Contact
Status Completed
Phase N/A
Start date November 2012
Completion date December 2012
View Details
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