Chronic renal disease N18
Conditions
Interventions
Group 1: Patients randomized to group A will have a run-in period of a maximum of 2 weeks of HD after which they will be treated for 12 weeks with MCO HD. Thereafter, patients in group A will be switc
Sponsors
Medizinische Universität Graz
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • Patient has dialysis-dependent end-stage renal disease • Male or female aged 18 years (both inclusive) at the time of signing informed consent • Patient if female is non-pregnant and if capable of becoming pregnant is using a medically acceptable means of contraception • Patient has been treated with HD or HDF therapy for 3 months or longer prior to study enrollment and is expected to survive at lease 12 months after enrollment • Patient has a stable functioning native fistula or graft capable of facilitating a blood flow rate >320mL/min • Patient is in clinically stable condition as judged by the treating physician and as demonstrated by stable medical history for 30 days prior to enrollment, physical examination, and laboratory testing • Patient is willing to comply with the study requirements for therapy during the entire study treatment period • Patient is capable of providing written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: • Patient is undergoing single-needle dialysis • Patient has a kappa immunoglobulin free light chains (? FLC)/? FLC ratio of less than 0.37, or greater than 3.1 • Patient has a known active infection and is currently receiving antibiotic treatment • Patient has known active cancer • Patient has a known positive serology test for human immunodeficiency virus (HIV) or hepatitis B, C or E • Patient has a known serious hemostasis disorder • Patient has a known monoclonal gammopathy (eg, monoclonal gammopathy of uncertain significance, smouldering [asymptomatic] multiple myeloma, symptomatic multiple myeloma, nonsecretory multiple myeloma, plasmacytomas, or plasma cell leukemia) • Patient has a known polyclonal gammopathy (eg, connective tissue disease, liver disease, chronic infection, lymphoproliferative disorder, or other hematologic condition) • Patient has any other known comorbidity that could, in the opinion of the Investigator, potentially conflict with the study purpose or procedures (eg, severe hypoalbuminemia or anemia) • Patient has a known significant psychiatric disorder or mental disability that could interfere with the patient’s ability to provide informed consent and/or comply with protocol procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured serum levels of large uraemic mean molecules (lambda-free immunoglobulin light chains (FLC)) prior to dialysis treatment, in comparison after 12 weeks of treatment with MCO-HD and hig-volume HDF | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the safety of a 12 week treatment with hemodialysis using a medium cut-off dialyzer | — |
Countries
Austria
Contacts
Public ContactAlexander Kirsch
Universitätsklinik für Innere Medizin, Abteilung für Nephrologie
Outcome results
None listed