End Stage Renal Disease, Renal Failure
Conditions
Keywords
Hemodialysis, Hemodiafiltration, Renal replacement therapy
Brief summary
The clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration
Detailed description
The primary objective of this study is to test whether the new FX P600 (applied during post-dilution online HDF) is non-inferior to two comparator dialyzers (Sureflux-17UX (Nipro) and Polyflux 170 H (Baxter/Gambro) in removing β2-microglobulin. The secondary objective is to exploratively compare the efficacy in removing other uremic solutes between the new FX P600 and the Sureflux-17UX as well as the Polyflux 170 H membranes. Additionally, the safety of the FX P600 dialyzer with a modified polysulfone membrane will be investigated.
Interventions
DEVICEDialyzer
Three hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H
Sponsors
Fresenius Medical Care Deutschland GmbH
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum age of 18 years * Existing informed consent form signed and dated by study patient as well as investigator/authorized physician * The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare his consent for participation in the clinical trial * Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on hemodiafiltration as extracorporeal renal replacement therapy
Exclusion criteria
* Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general stable condition of the patient (e.g. absence of any acute condition, e.g. infection or mental problem which might give reason for concern etc.). * Ongoing participation in an interventional clinical study during the preceding 30 days * Previous participation in this study * Pregnancy (pregnancy test will be conducted with female patients aged ≤ 55 years) or lactation period * Patient is not able to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Removal rate of β2-microglobulin | t=240 minutes of HDF | Removal rate of β2-microglobulin will be calculated as primary endpoint in blood samples to evaluate the clinical performance of the new FX P600 dialyzer. |
Secondary
| Measure | Time frame |
|---|---|
| Clearance of β2-microglobulin | t=60 minutes of HDF |
| Removal rate of α1-microglobulin | t=240 minutes of HDF |
| Clearance of α1-microglobulin | t= 60 minutes of HDF |
Countries
Germany
Outcome results
None listed