NCT01327391.

Trial name or title	Tolerance of "on Line" hemodiafiltration in chronic renal failure patients (on‐line‐HDF)
Methods	Country: France Setting: multi‐centre, 36 French centres Study time frame: 2005 to December 2012 Study design: parallel RCT Enrolment: 600 patients Duration of follow‐up: 2 years
Participants	Ages eligible for study: 65 to 90 years Inclusion criteria: patient who has signed the written consent form; aged > 65 and < 90 years; creatinine clearance < 10 mL/min; on dialysis for a minimum of 3 months; with 3 times/week haemodialysis sessions; erythropoietin dosage needed to maintain haemoglobin at a constant level (range of haemoglobin: 9 to 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
Interventions	Active arm: on‐line haemodiafiltration Haemodialysis patients treated with on line HDF technic Procedure: on line haemodiafiltration 3 sessions/week; 3‐4 hours per session Comparator: haemodialysis Haemodialysis patients treated with conventional haemodialysis technic using high‐flux dialyzers Procedure: haemodialysis 3 sessions/week; 3‐4 hours per session; high‐flux dialyzers
Outcomes	Primary outcome measures Tolerance of "on line" HDF treatment versus conventional high‐flux haemodialysis in terms of adverse events occurring during dialysis sessions (time frame: between day 30 and day 120 of treatment) Secondary outcome measures Quality of life evaluated with the KDQOL questionnaire (time frame: day 0, 180, 365, 730) Incidence of cardiovascular events (time frame: 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) All‐cause and cardiovascular mortality (time frame: 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 Influence of the technic on microbiological safety (time frame: day 180, 365, 730); measure of microbiological purity of dialysate 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)
Starting date	May 2005
Contact information	Prof Bernard CANAUD, Centre Hospitalier Universitaire Montpellier France Sponsors and Collaborators: University Hospital, Montpellier Ministry of Health, France
Notes	Estimated study completion date: December 2012 source: http://clinicaltrials.gov/ct2/results?term=NCT01327391&Search=Search