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CompletedNCT02374372PHARMACO-$Updated Dec 8, 2022

Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit

An interventional study of conventional hemodialysis and hemodiafiltration On-line in Chronic Renal Failure and Hemodialysis, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-08.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The site where the clinical trial will be conducted is at the St-Luc hospital from the CHUM. This is a prospective randomized study that will compare the two treatment modalities, HD and HDF, through economics and pharmaco-economics parameters.

Patients, who had previously been randomized in the CONTRAST study, will remain in their respective group and monitoring will continue. The next patients will be randomized in the same way (1: 1) using the same inclusion and exclusion criteria. HDF randomized patients will receive post-dilution standard reinjection (at least 100ml/min or 6 liter/hr). In rare cases, HDF patients can briefly have reinjection on a pre-dilution mode (if heparin need to be avoided for example) and the reinjection flow should be adjusted accordingly (200ml/min).

Length and frequency of sessions will be the same in the 2 groups. Blood tests will not change and will be the same than those used as routine assessments. Metabolic control of patients will be maintained according to the guidelines. Patients will be monitored for a minimum of 3 years. A set of demographic and clinical data will be collected from patient medical records and throughout the study.

Biochemical data as part of the usual blood tests of dialysis patients will be collected each month as well as will be stored and analyzed information about the annual cardiac ultrasounds.

All events will be scored (hospitalizations, patterns, duration) and the list and cost of drugs will be compiled every three months. These data will be useful in the economic analysis comparing the two treatment modalities.

02

Conditions studied

  • Chronic Renal Failure
  • Hemodialysis

Keywords

  • hemodialysis
  • beta microglobulin
  • amyloidosis
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 140 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 370 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • more than 18 years old,
  • able to consent,
  • patient needs to be on hemodialysis more than 8-12 hours a week (2-3 sessions)

Exclusion criteria

Exclusion Criteria:

  • severe none compliance (often missing sessions without good reasons),
  • life expectation less than 3 months,
  • treated with high-flux filters in the last 6 months
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Active comparator
    conventional hemodialysis

    conventional hemodialysis

    Device: conventional hemodialysis

  • Active comparator
    hemodiafiltration On-line

    hemodiafiltration On-line

    Device: hemodiafiltration On-line

Interventions

  • Deviceconventional hemodialysis
  • Devicehemodiafiltration On-line
06

What researchers measure

Primary outcomes

  1. compare the medication cost between the 2 groups (HD and HDF)

    Time frame: 3 years

  2. demonstrate lower cost of erythropoietin in HDF, with same control of anemia to HD group

    Time frame: 3 years

  3. demonstrate lower cost of phosphate binder in HDF, with same control of phospho calcium balance to HD group

    Time frame: 3 years

Secondary outcomes

  1. demonstrate lower need of Erythropoietin and best control of anemia in HDF

    Time frame: 3 years

  2. demonstrate lower need of phosphate binder and best control of phospho-calcique balance in HDF

    Time frame: 3 years

  3. demonstrate less hospitalization stay and cost related in HDF group

    Time frame: 3 years

  4. stabilisation or regression of left ventricular hypertrophy

    Time frame: 3 years

07

Study locations

1 site
  • Centre hospitalier Universitaire de Montréal (CHUM)
    Montréal, Quebec H2X 3J4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02374372
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Responsible party
Sponsor
First posted
Feb 27, 2015
Start date
Jan 2011
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Dec 8, 2022

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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