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OpenTrials
Completed

NCT Number: NCT01534741

Comparison FX CorDiax 60 in Relation to the FX 60-Dialyzer

Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic hemodialysis patients Treatment: Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type.

Study objectives: Intraindividual comparison of removal rate of urea, phosphate, ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during post-dilution online hemodiafiltration.

Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea, phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects

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Key information

Conditions

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínic

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who are treated by post dilution on-line HDF for at least three months.
  • Patients who reached a dialysis dose (Kt/V) of at least 1.2 at the last two monthly checks,
  • Patients who are on a stable anticoagulation and anemia management,
  • Patients who are clinically stable outlined by the medical history of the patient, based on judgment of principal investigator,
  • Patients who are on a regular thrice weekly HDF schedule,
  • Patients who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (> 300 ml/min),
  • Patients who are able to understand the nature and requirements of the clinical investigation and have given written informed consent,
  • Patients who are aged 18 years or older.

Exclusion criteria

  • Patients who do not meet the inclusion criteria,
  • Patients with active HBV, HCV, HIV infection,
  • Patients who are severely malnourished patients as judged by the principal investigator,
  • Patients who are known or suspected to have allergy to the trial products or related products,
  • Patients who are abusing non-legal drugs or alcohol (defined as an average daily intake of more than one liter of beer per day or an equivalent amount of alcohol in other beverages),
  • Patients who have been diagnosed a current active malignant disease,
  • Patients who participate simultaneously in another clinical investigation or in other clinical investigations during the last month,
  • Patients who are uncooperative.

Treatment and study plan

Dialyzer comparison

Other

Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type (FX CorDiax 60or FX 60 ) The order of dialyzers used will be randomly assigned to the patient at the time of randomisation by lot. Every subject will be treated one time with each dialyzer. In order to achieve controlled conditions, the mid- or end-week session data will be used, only.

dialyzer

Device

Comparison Dialyzer FX60 versus Cordiax60

Primary outcomes

  1. Removal rate of myoglobin

    Time frame: 2 weeks

Secondary outcomes

  1. Removal rate of urea

    Time frame: 2 weeks

  2. Removal rate of phosphate

    Time frame: 2 weeks

  3. Removal rate of ß2-microglobulin (ß2-m)

    Time frame: 2 weeks

  4. Removal rate of prolactin

    Time frame: 2 weeeks

  5. Removal rate of alpha1-microglobulin

    Time frame: 2 weeks

  6. Removal rate of alpha1-acid glycoprotein

    Time frame: 2 weeks

  7. Hematocrit pre and post-dialysis

    Time frame: 2 weeks

  8. Albumin loss during dialysis session

    Time frame: 2 weeks

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Fresenius Medical Care Deutschland GmbH

Registry information

Official study title

Investigation on the Middle Size Molecule Elimination Characteristics of the FX CorDiax 60 in Relation to the FX 60-Dialyzer

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2012
Registry last updated
Apr 9, 2014

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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