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Cardiovascular DiseasePhase 4on-line-HDFNCT01327391

Tolerance of "on Line" Hemodiafiltration in Chronic Renal Failure Patients

A Phase 4 study testing On line Hemodiafiltration and Hemodialysis in people with Cardiovascular Disease, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to appreciate the tolerance of "on line" hemodiafiltration and its impact on morbidity and cardiovascular risk factors in chronic renal failure patient. Read more about this study

Who is it for?
Ages 65 to 90 years
Conditions the study is for
Cardiovascular Disease
What is being tested?
On line Hemodiafiltration and Hemodialysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
415 participants
Where
1 siteFrance
Study dates
May 2005to May 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 90 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patient who has signed the written consent form
  • Patient aged > 65 and < 90 years
  • With creatinine clearance < 10 mL/min
  • On dialysis for a minimum of 3 months, with 3 times a week hemodialysis sessions
  • Erythropoietin dosage needed to maintain hemoglobin at a constant level (range of hemoglobin: 9-13 g/dL without any variation of more than 2g/dL for less than 3 months)
  • Without any problem of vascular access

Who cannot join

  • Patient aged < 65 and > 90 years
  • Presence of severe malnutrition (albumin < 20 g/L)
  • Unstable clinical condition
  • Unipuncture or failed vascular access flow
  • Known problems of coagulation

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Hospitalier Universitaire

    Montpellier, 34295

Other trials in France

About this study

Official title: Tolerance of "on Line" Hemodiafiltration and Impact on Morbidity and Cardiovascular Risk Factors in Chronic Renal Failure Patients

The aim of this study is to appreciate the tolerance of "on line" hemodiafiltration and its impact on morbidity and cardiovascular risk factors in chronic renal failure patient.

Read the detailed description

The aim of this study is to appreciate the tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions between day 30 and day 120 of treatment and to evaluate:

  • Quality of life evaluated with the KDQOL questionnaire
  • Incidence of cardiovascular events
  • Influence of the technic on cardiovascular, inflammatory and infectious risk factors
  • Mortality
Being tested
On line Hemodiafiltration, Hemodialysis
Keywords
on line hemodiafiltration, tolerance, quality of life, cardiovascular risk, Hemodialysis patients
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • On line HemodiafiltrationProcedure or surgery

    Also called on line HDF, HDF

    3 sessions/week; 3-4 hours per session

  • HemodialysisProcedure or surgery

    Also called conventional hemodialysis

    3 sessions/week; 3-4 hours per session; high flux dialyzers

Study groups in NCT01327391
Study groupRoleWhat they receive
On line HemodiafiltrationActive comparatorHemodialysis patients treated with on line hemodiafiltration technic
Receives: Procedure: On line Hemodiafiltration
hemodialysisOtherHemodialysis patients treated with conventional hemodialysis technic using high flux dialyzers
Receives: Procedure: Hemodialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions

    Measured: between day 30 and day 120 of treatment

Secondary outcomes (7)

  1. Quality of life evaluated with the KDQOL questionnaire

    Measured: day 0, 180, 365, 730

  2. Incidence of cardiovascular events

    Measured: day 180, 365, 730

  3. Influence of the technic on mineral metabolism disturbances

    measure of mineral metabolism parameters (Ca, PO4, PTH)

    Measured: day 180, 365, 730

  4. All cause and cardiovascular mortality

    Measured: day 180, 365, 730

  5. Influence of the technic on inflammatory parameters

    measure of pro-inflammatory cytokines and acute phase reactant proteins

    Measured: day 180, 365, 730

  6. Influence of the technic on microbiological safety

    measure of microbiological purity of dialysate

    Measured: day 180, 365, 730

  7. Influence of the technic on oxidative stress parameters

    measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E)

    Measured: day 180, 365, 730

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2011 (estimated)
  2. Study startMay 2005
  3. Primary completionMay 2013
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01327391
Sponsor's protocol ID
7753
Acronym
on-line-HDF
Status last verified
Mar 2011
First submitted
14 Jan 2008
Last updated
14 May 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Morena M, Jaussent A, Chalabi L, Leray-Moragues H, Chenine L, Debure A, Thibaudin D, Azzouz L, Patrier L, Maurice F, Nicoud P, Durand C, Seigneuric B, Dupuy AM, Picot MC, Cristol JP, Canaud B; FRENCHIE Study Investigators. Treatment tolerance and patient-reported outcomes favor online hemodiafiltration compared to high-flux hemodialysis in the elderly. Kidney Int. 2017 Jun;91(6):1495-1509. doi: 10.1016/j.kint.2017.01.013. Epub 2017 Mar 18.

    PubMed 28318624

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing On line Hemodiafiltration and Hemodialysis in people with Cardiovascular Disease, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tolerance of "on line" HDF treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions (time frame: between day 30 and day 120 of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01327391, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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