Performance Comparison of Revaclear With Larger Dialyzer (Revacom HD)

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

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

Study Overview

• Status: Completed
• Conditions: Renal Failure Chronic Requiring Hemodialysis
• Intervention / Treatment: Other: Dialyzer comparison

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University Graz
  • Graz, Austria, 8010
    • Dialyseinstitut Prim. Dr. W. Gießauf GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Revaclear followed by FX	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.
Other: FX followed by Revaclear	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dialysis dose Kt/V urea	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.	2 weeks (6 consecutive dialysis sessions)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction rate of urea, creatinine, phosphate and ß2-microglobulin	Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%).	2 weeks (6 consecutive dialysis sessions)
Total removal of creatinine, phosphate and ß2-microglobulin	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.	2 weeks (6 consecutive dialysis sessions)
Albumin loss	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.	2 weeks (6 consecutive dialysis sessions)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood count	Parameters are hemoglobin concentration (g/dL), hematocrit (%), thrombocyte concentration (G/L), erythrocyte concentration (T/L), leukocyte concentration (G/L).	2 weeks (start and end of 6 consecutive dialysis sessions)

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Gambro Dialysatoren GmbH
• Investigators: Principal Investigator: Alexander Rosenkranz, Prof., Medical University Graz, Austria

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 22, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 7, 2012

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 1499