Performance Comparison of Revaclear With Larger Dialyzer

NCT01722695 | Completed

• 1 other identifier: 1499
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Renal Failure Chronic Requiring Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Reduction rate of urea, creatinine, phosphate and ß2-microglobulin

  2 weeks (6 consecutive dialysis sessions)

• Total removal of creatinine, phosphate and ß2-microglobulin

  2 weeks (6 consecutive dialysis sessions)

• Albumin loss

  2 weeks (6 consecutive dialysis sessions)

Other Outcomes (1)

• Blood count

  2 weeks (start and end of 6 consecutive dialysis sessions)

Study Arms (2)

Revaclear followed by FX

OTHER

Other: Dialyzer comparison

FX followed by Revaclear

OTHER

Other: Dialyzer comparison

Interventions

Dialyzer comparison OTHER

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.

FX followed by Revaclear; Revaclear followed by FX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vantive Health LLC: lead
• Gambro Dialysatoren GmbH: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (2)

Dialyseinstitut Prim. Dr. W. Gießauf GmbH

Graz, 8010, Austria

Location

Medical University Graz

Graz, 8036, Austria

Location

Study Officials

• Alexander Rosenkranz, Prof.

  Medical University Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: November 7, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

AU (2)