N28.9
Conditions
Interventions
Group 1: Hämodialysis for 4 weeks, following On-Line Hämodiafiltration for 12 weeks
Group 2: On-Line Hämodiafiltration for 4 weeks, following Haemodialysis for 12 weeks
Sponsors
Universitätsklinik für Innere Medizin, Abteilung für Nephrologie
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: • Signed informed consent prior to any study specific screening procedures. • Male or female between 18 and 80 years of age. • Subjects must have an arteriovenous shunt as vascular access with a blood flow > 450ml/min facilitating a blood flow rate >350ml/min, confirmed by ultrasound. • Subjects must have a haemoglobin level between 9 and 13g/dl • At inclusion, all subjects must have been treated for at least 1 month, three times a week with at least 240-min bicarbonate HD using a synthetic biocompatible dialysis membrane • Subjects must be oligoanuric at the time of randomization (<400ml/day), as reported by the subjects • Otherwise in stable health as determined by the investigator and based on medical history and routine laboratory test during the screening period.
Exclusion criteria
Exclusion criteria: • History of active, clinically significant, respiratory, gastrointestinal, hepatic, neurologic psychiatric, musculoskeletal, genitourinary, derma-tological, or other disorders that, in the investigator´s opinion, could affect the conduct of the study. • Subjects who have had any major cardiovascular event within 180 days prior to randomization, including but not limited to: myocardial in-farction, unstable angina, cerebrovascular accident, pulmonary embo-lism, or New York Heart Association Class III or IV heart failure. • Presence of cancer • Severe hypertension (SBP >180mmHg prior to start of the dialysis session) • Severe malnutrition (Albumin 1000pg/ml) • Positive serologic test for hepatitis B or hepatitis C or a positive result of test for HIV antibodies within the last 12 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in plasma metabolomic and proteomic profiles after 4 weeks post-dilution On Line-Haemodiafiltration versus Haemodialysis treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| · Change of metabolomic and proteomic profiles in pre- and postdialysis plasma samples: post-dilution On Line-Haemodiafiltration versus Haemodialysis at day 1 and Visit 5 · Change in plasma metabolomic and proteomic profile after 12 weeks post-dilution On Line-Haemodiafiltration versus Haemodialysis treatment · Change of the listed parameters in pre-dialysis plasma samples: postdilution On Line-Haemodiafiltration versus Haemodialysis at day 1 and at Visit 3, 4 and 5. · Standard laboratory values (haematology, clinical chemistry) · Albumin · Calcium · Phosphate · Magnesium · 25-OH Vitamin D · PTH (parathyroid hormone) · CRP · b2-microglobulin · Serum amyloid A1 · Indoxyl sulphate · p-cresyl sulphate · p-cresyl glucuronide · FGF23 · ADMA · TNF-a · IL-6 · Leptin | — |
Countries
Austria
Contacts
Public ContactStefanie Sach-Friedl
Medizinische Universität Graz, Clinical Research Center
Outcome results
None listed