Tolerance of "on Line" Hemodiafiltration in Chronic Renal Failure Patients (on-line-HDF)

May 11, 2026 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
415

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: On line Hemodiafiltration
Hemodialysis patients treated with on line hemodiafiltration technic
Procedure: On line Hemodiafiltration
3 sessions/week; 3-4 hours per session
Other Names:
  • on line HDF
  • HDF
Other: hemodialysis
Hemodialysis patients treated with conventional hemodialysis technic using high flux dialyzers
Procedure: Hemodialysis
3 sessions/week; 3-4 hours per session; high flux dialyzers
Other Names:
  • conventional hemodialysis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
between day 30 and day 120 of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life evaluated with the KDQOL questionnaire
Time Frame: day 0, 180, 365, 730
day 0, 180, 365, 730
Incidence of cardiovascular events
Time Frame: day 180, 365, 730
day 180, 365, 730
Influence of the technic on mineral metabolism disturbances
Time Frame: day 180, 365, 730
measure of mineral metabolism parameters (Ca, PO4, PTH)
day 180, 365, 730
All cause and cardiovascular mortality
Time Frame: day 180, 365, 730
day 180, 365, 730
Influence of the technic on inflammatory parameters
Time Frame: day 180, 365, 730
measure of pro-inflammatory cytokines and acute phase reactant proteins
day 180, 365, 730
Influence of the technic on microbiological safety
Time Frame: day 180, 365, 730
measure of microbiological purity of dialysate
day 180, 365, 730
Influence of the technic on oxidative stress parameters
Time Frame: day 180, 365, 730
measure of oxidative stress markers (AOPP, AGE) and antioxidant systems (vitamin E)
day 180, 365, 730

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Didier AGUILERA, Dr, CHG Vichy France
  • Study Chair: Lynda AZZOUZ, Dr, CH Roanne France
  • Study Chair: Jean-Marie BATHO, Dr, CH privé Saint Martin Caen France
  • Study Chair: Francois COMBARNOUS, Dr, Clinique du Tonkin Villeurbanne France
  • Study Chair: Lotfi CHALABI, Dr, AIDER Montpellier France
  • Study Chair: Guy DEGREMONT, Dr, CHG Cambrai France
  • Study Chair: Maxime HOFFMANN, Dr, Clinique de la Louvière Lille France
  • Study Chair: Gérard DESCHODT, Dr, AIDER Nimes France
  • Study Chair: Assia DJEMA, Dr, CHG Cholet France
  • Study Chair: Alain DUBOUST, Dr, Clinique du Vert Galant, Tremblay en France, France
  • Study Chair: Alexandre DUMOULIN, Dr, CHLM Beziers France
  • Study Chair: Baya FADEL-BABBA, Dr, AGDUC La Tronche France
  • Study Chair: Enrique FIGUEROA, Dr, CH Briancon France
  • Study Chair: Thierry HAAS, Dr, CMCO Evry France
  • Study Chair: Jean-Michel HARDIN, Dr, CH Soissons France
  • Study Chair: Daniel HILLION, Dr, CHI Poissy France
  • Study Chair: Guillaume JEAN, Dr, CRAT Tassin La Demi Lune France
  • Study Chair: Véronique JOYEUX, Pr, CHU Pontchaillou Rennes France
  • Study Chair: Kristian KUNZ, Dr, AURAL France
  • Study Chair: Antoine LACAILLE, Dr, UNHEP Aulnay sous Bois France
  • Study Chair: Jacques LEBLEU, Dr, Clinique néphrologique Pont Allant Maubeuge France
  • Study Chair: Vincent LEMAITRE, Dr, CHG Valenciennes France
  • Study Chair: Mehadji MAAZ, Dr, CH Louis Pasteur Colmar France
  • Study Chair: Philippe NICOUD, Dr, Clinique Centre Vallée Blanche Chamonix France
  • Study Chair: Jean-Paul ORTIZ, Dr, Polyclinique Saint Roch Cabestany France
  • Study Chair: Jacky POTIER, Dr, CH Louis Pasteur Cherbourg France
  • Study Chair: Olivier PUYOO, Dr, Clinique Néphrologique Occitanie Muret France
  • Study Chair: Véronique QUERON, Dr, Polyclinique Francheville Perigueux France
  • Study Chair: Gilles SCHUTZ, Dr, Centre HD Provence Aubagne France
  • Study Chair: Francois MAURICE, Dr, CHLM Montpellier France
  • Study Chair: Bruno SEIGNEURIC, Dr, CHU Larrey Toulouse France
  • Study Chair: Frederic TOLLIS, Dr, CHU Angers France
  • Study Chair: Carlos VELA, Dr, CH Perpignan France
  • Study Chair: Francois WAMBERGUE, Dr, Clinique du Bois Lille France
  • Study Chair: Christian WOLF, Dr, CH Toulon France
  • Study Chair: Jean-Paul CRISTOL, Pr, CHU Lapeyronie Montpellier France
  • Principal Investigator: Bernard CANAUD, Pr, CHU Lapeyronie Montpellier France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7753

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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