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Completed

NCT Number: NCT01722695

Performance Comparison of Revaclear With Larger Dialyzer

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

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Key information

Conditions

Renal Failure Chronic Requiring Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dialyseinstitut Prim. Dr. W. Gießauf GmbH, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Dialysis dose Kt/V urea

    Time frame: 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 outcomes

  1. Reduction rate of urea, creatinine, phosphate and ß2-microglobulin

    Time frame: 2 weeks (6 consecutive dialysis sessions)

    Calculation from pre and post dialysis plasma concentrations. Unit of measure is percentage (%).

  2. Total removal of creatinine, phosphate and ß2-microglobulin

    Time frame: 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.

  3. Albumin loss

    Time frame: 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.

Other outcomes

  1. Blood count

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

    Parameters are hemoglobin concentration (g/dL), hematocrit (%), thrombocyte concentration (G/L), erythrocyte concentration (T/L), leukocyte concentration (G/L).

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation
  • Gambro Dialysatoren GmbH

Registry information

Official study title

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

Acronym: Revacom HD

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Nov 7, 2012
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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