Performance Comparison of Revaclear With Larger Dialyzer

Not Applicable

Completed

• Conditions: Renal Failure Chronic Requiring Hemodialysis
• Interventions: Other: Dialyzer comparison

• Registration Number: NCT01722695
• Lead Sponsor: Vantive Health LLC

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-22
• Study Start: 2012-11
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• chronic renal failure and stable treatment with hemodialysis or hemodiafiltration for at least 3 months
• patients aged 18 years or more
• written consent to participate in the study (informed consent)
• dialysis via native fistula or Gore-Tex graft capable of providing a blood flow rate of at least 300 mL/min

Exclusion Criteria

• single-needle dialysis
• pregnant and lactating women
• participation in other interventional studies less than 3 months prior to study start
• non-compliance with the dialysis prescription
• hematocrit less than 28%
• hospitalization
• antibiotic therapy
• active infection
• active cancer
• known positive serology for HIV, hepatitis B or C
• serious hemostasis disorders
• any comorbidity possibly conflicting with the study purpose or procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
FX followed by Revaclear	Dialyzer comparison	-
Revaclear followed by FX	Dialyzer comparison	-

Primary Outcome Measures

Name	Time	Method
Dialysis dose Kt/V urea	2 weeks (6 consecutive dialysis sessions)	Calculation from pre and post plasma urea concentration or urea nitrogen, session length, ultrafiltration volume and post dialysis weight. Dialysis dose does not have a unit of measure.

Secondary Outcome Measures

Name	Time	Method
Total removal of creatinine, phosphate and ß2-microglobulin	2 weeks (6 consecutive dialysis sessions)	Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment.
Reduction rate of urea, creatinine, phosphate and ß2-microglobulin	2 weeks (6 consecutive dialysis sessions)	Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%).
Albumin loss	2 weeks (6 consecutive dialysis sessions)	Calculation from measured concentration in integrated dialysate sample over entire treatment, dialysate flow rate, treatment duration and ultrafiltration volume. Unit of measure is g or mg per treatment.

Trial Locations

Locations (2)

Medical University Graz; 🇦🇹 Graz, Austria

Dialyseinstitut Prim. Dr. W. Gießauf GmbH; 🇦🇹 Graz, Austria