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

This study has been completed.
Sponsor:
Collaborator:
Fresenius Medical Care Deutschland GmbH
Information provided by (Responsible Party):
Francisco Maduell, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01534741
First received: February 10, 2012
Last updated: April 8, 2014
Last verified: July 2012
  Purpose

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


Condition Intervention Phase
Hemodialysis
Other: dialyzer comparison
Device: Dialyzer
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Investigation on the Middle Size Molecule Elimination Characteristics of the FX CorDiax 60 in Relation to the FX 60-Dialyzer

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Removal rate of myoglobin [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Removal rate of urea [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Removal rate of phosphate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Removal rate of ß2-microglobulin (ß2-m) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Removal rate of prolactin [ Time Frame: 2 weeeks ] [ Designated as safety issue: No ]
  • Removal rate of alpha1-microglobulin [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Removal rate of alpha1-acid glycoprotein [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Hematocrit pre and post-dialysis [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Albumin loss during dialysis session [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dialyser
FX CorDiax 60 dialyzer
Other: dialyzer comparison
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.
Device: Dialyzer
Comparison Dialyzer FX60 versus Cordiax60
Active Comparator: FXDialyser
FX 60 dialyzer
Device: Dialyzer
Comparison Dialyzer FX60 versus Cordiax60

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534741

Locations
Spain
Hospital Clínic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Fresenius Medical Care Deutschland GmbH
  More Information

Publications:
Responsible Party: Francisco Maduell, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01534741     History of Changes
Other Study ID Numbers: HD-IIT-02-E
Study First Received: February 10, 2012
Last Updated: April 8, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

ClinicalTrials.gov processed this record on August 20, 2014