End-stage renal disease Urological and Genital Diseases Renal disease
Conditions
Interventions
Hemodialysis treatment with high-flux versus low-flux dialysers of the same type of chemical composition
Sponsors
Gambro SAS (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Medically stable end-stage renal disease patients on hemodialysis for 6 months or more 2. Age =18 years 3. C-reactive protein between 5 and 50 mg/l maximum one week before inclusion 4. Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) serologies negative 5. Not under guardianship 6. AgHbs negative 7. Absence of vascular access thrombosis 8. Absence of clinically identifiable cause of chronic inflammation 9. Treatment in a dialysis unit providing water quality according to the European Pharmacopoeia 10. Statin medication allowed, but no introduction or modification during the study 11. Hemodialysis blood flow rates between 200 and 500 ml/min possible 12. Dialysis frequency 3-4 per week
Exclusion criteria
Exclusion criteria: 1. Age >75 years 2. Known pregnancy 3. Severe comorbidities with life expectancy <1 year 4. Cancer except skin cancer 5. Severe digestive pathologies 6. Chronic inflammatory diseases 7. Medication interfering with nutritional or inflammatory status 8. Treatment or intention to treat with immunosuppressive medication 9. Dialysis dose Kt/V <1.2, and dialysis time <10 hours per week 10. Treatment with hemofiltration or hemodiafiltration 11. Participation in another study during the preceding 30 days 12. Physically or mentally disabled patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of C-reactive protein | — |
Secondary
| Measure | Time frame |
|---|---|
| Advanced glycation end products, carboxymethyl lysine, asymmetric dimethyl arginine, fibrinogen, albumin and prealbumin, phosphate | — |
Countries
France
Outcome results
None listed