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The clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodiafiltration HDF | Other | Three consecutive treatment weeks and on follow-up week per patient. Each treatment week includes three hemodiafiltration HDFsessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Nipro: Sureflux-17UX and comparator Baxter/Gambro: Polyflux 170 H. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialyzer | Device | Three hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H |
|
| Measure | Description | Time Frame |
|---|---|---|
| Removal rate of β2-microglobulin | 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. | t=240 minutes of HDF |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen | Hanover | Lower Saxony | 30453 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35373083 | Derived | 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. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D007688 | Kidneys, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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Prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center
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| t= 60 minutes of HDF |
| Diakonissenkrankenhaus Flensburg |
| Flensburg |
| 24939 |
| Germany |
| Georg-Haas-Dialysezentrum der PHV | Giessen | 35392 | Germany |
| PHV-Dialysezentrum Goslar | Goslar | 38642 | Germany |
| PHV Dialysezentrum Kiel | Kiel | 24106 | Germany |
| PHV-Dialysezentrum Lauterbach | Lauterbach | 36341 | Germany |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |