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Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration

NCT ID: NCT03611218

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-29

Study Completion Date

2018-12-08

Brief Summary

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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

Detailed Description

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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.

Conditions

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Renal Failure End Stage Renal Disease

Keywords

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Hemodialysis Hemodiafiltration Renal replacement therapy

Study Design

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Intervention Model

SEQUENTIAL

Prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hemodiafiltration HDF

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.

Group Type OTHER

Dialyzer

Intervention Type DEVICE

Three hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H

Interventions

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Dialyzer

Three hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

Hanover, Lower Saxony, Germany

Site Status

Diakonissenkrankenhaus Flensburg

Flensburg, , Germany

Site Status

Georg-Haas-Dialysezentrum der PHV

Giessen, , Germany

Site Status

PHV-Dialysezentrum Goslar

Goslar, , Germany

Site Status

PHV Dialysezentrum Kiel

Kiel, , Germany

Site Status

PHV-Dialysezentrum Lauterbach

Lauterbach, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 35373083 (View on PubMed)

Other Identifiers

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HD-FX-06-D

Identifier Type: -

Identifier Source: org_study_id