NCT01327391

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
415

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2005

Longer than P75 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

May 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2008

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

April 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 14, 2026

Status Verified

March 1, 2011

Enrollment Period

8 years

First QC Date

January 14, 2008

Last Update Submit

May 11, 2026

Conditions

Cardiovascular Disease

Keywords

on line hemodiafiltrationtolerancequality of lifecardiovascular riskHemodialysis patients

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Quality of life evaluated with the KDQOL questionnaire

    day 0, 180, 365, 730

  • Incidence of cardiovascular events

    day 180, 365, 730

  • Influence of the technic on mineral metabolism disturbances

    day 180, 365, 730

  • All cause and cardiovascular mortality

    day 180, 365, 730

  • Influence of the technic on inflammatory parameters

    day 180, 365, 730

  • +2 more secondary outcomes

Study Arms (2)

On line Hemodiafiltration

ACTIVE COMPARATOR

Hemodialysis patients treated with on line hemodiafiltration technic

Procedure: On line Hemodiafiltration

hemodialysis

OTHER

Hemodialysis patients treated with conventional hemodialysis technic using high flux dialyzers

Procedure: Hemodialysis

Interventions

On line HemodiafiltrationPROCEDURE

3 sessions/week; 3-4 hours per session

Also known as: on line HDF, HDF
On line Hemodiafiltration
HemodialysisPROCEDURE

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

Also known as: conventional hemodialysis
hemodialysis

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 28318624RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Renal Dialysis

Intervention Hierarchy (Ancestors)

Renal Replacement TherapyTherapeuticsSorption Detoxification

Study Officials

  • 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

    STUDY CHAIR

  • Bernard CANAUD, Pr

    CHU Lapeyronie Montpellier France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2008

First Posted

April 1, 2011

Study Start

May 1, 2005

Primary Completion

May 1, 2013

Study Completion

May 1, 2014

Last Updated

May 14, 2026

Record last verified: 2011-03

Locations

FR(1)