NCT01534741

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 9, 2014

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

February 10, 2012

Last Update Submit

April 8, 2014

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Removal rate of myoglobin

    2 weeks

Secondary Outcomes (8)

  • Removal rate of urea

    2 weeks

  • Removal rate of phosphate

    2 weeks

  • Removal rate of ß2-microglobulin (ß2-m)

    2 weeks

  • Removal rate of prolactin

    2 weeeks

  • Removal rate of alpha1-microglobulin

    2 weeks

  • +3 more secondary outcomes

Study Arms (2)

Dialyser

ACTIVE COMPARATOR

FX CorDiax 60 dialyzer

Other: dialyzer comparisonDevice: Dialyzer

FXDialyser

ACTIVE COMPARATOR

FX 60 dialyzer

Device: Dialyzer

Interventions

dialyzer comparisonOTHER

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.

Dialyser
DialyzerDEVICE

Comparison Dialyzer FX60 versus Cordiax60

DialyserFXDialyser

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

  • Maduell F, Arias-Guillen M, Fontsere N, Ojeda R, Rico N, Vera M, Elena M, Bedini JL, Wieneke P, Campistol JM. Elimination of large uremic toxins by a dialyzer specifically designed for high-volume convective therapies. Blood Purif. 2014;37(2):125-30. doi: 10.1159/000358214. Epub 2014 Mar 20.

    PMID: 24662288RESULT

MeSH Terms

Interventions

Kidneys, Artificial

Intervention Hierarchy (Ancestors)

Artificial OrgansSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 17, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 9, 2014

Record last verified: 2012-07

Locations

ES(1)