Clinical trial NCT03611218: Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration
Official title: Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration - eMPORA II Study (Modified POlysulfone membRAne)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
End Stage Renal Disease
Keywords: Hemodialysis
Hemodiafiltration
Renal replacement therapy
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: Prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Removal rate of β2-microglobulin
timeFrame: t=240 minutes of HDF
Secondary outcomes:
measure: Clearance of β2-microglobulin
timeFrame: t=60 minutes of HDF
measure: Removal rate of α1-microglobulin
timeFrame: t=240 minutes of HDF
measure: Clearance of α1-microglobulin
timeFrame: t= 60 minutes of HDF
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
state: Niedersachsen
city: Flensburg
country: Germany
facility: Diakonissenkrankenhaus Flensburg
city: Giessen
country: Germany
facility: Georg-Haas-Dialysezentrum der PHV
city: Goslar
country: Germany
facility: PHV-Dialysezentrum Goslar
city: Kiel
country: Germany
facility: PHV Dialysezentrum Kiel
city: Lauterbach
country: Germany
facility: PHV-Dialysezentrum Lauterbach
Study officials:
References:
citation: Ehlerding G, Erlenkotter A, Gauly A, Griesshaber B, Kennedy J, Rauber L, Ries W, Schmidt-Gurtler H, Stauss-Grabo M, Wagner S, Zawada AM, Zschatzsch S, Kempkes-Koch M. Performance and Hemocompatibility of a Novel Polysulfone Dialyzer: A Randomized Controlled Trial. Kidney360. 2021 Apr 7;2(6):937-947. doi: 10.34067/KID.0000302021. eCollection 2021 Jun 24.