Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration

NCT ID: NCT04102280

Last Updated: 2021-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-29
• Study Completion Date: 2021-05-26

Brief Summary

The clinical investigation will be performed to generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil obligations to follow the FX P600 dialyzer in the market.

Detailed Description

The primary objective of this study is to test whether the FX P600 is non-inferior to the Xevonta Hi 15 dialyzer and the Elisio 150H dialyzer in removing β2-microglobulin related to the albumin removal into the dialysate during high volume online hemodiafiltration.

The secondary objective of this study is to compare the FX P600 dialyzer with the comparator dialyzers with regard to their efficacies in removing other performance variables (see below). Furthermore, the safety of the FX P600 will be investigated by collecting and analyzing clinical adverse events.

Conditions

Renal Failure; End Stage Renal Disease

Keywords

Hemodialysis; Hemodiafiltration; Renal replacement therapy

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemodiafiltration HDF

Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro)

Group Type: OTHER

Dialyser

Intervention Type: DEVICE

Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro)

Interventions

Dialyser

Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

General:

• Informed consent signed and dated by study patient and investigator/authorized physician
• Minimum age of 18 years
• Legally competent and able to understand the nature, risk, meaning, and consequences of the clinical trial (cf. MPG § 20 Sec. 2 Sentence 1 No. 1)
• Chronic kidney disease stage 5D (end stage renal disease) on hemodiafiltration as extracorporeal renal replacement therapy

Study-specific:

• On high volume online (>21 L/session substitution volume postdilution per session) hemodiafiltration (HDF), at least 4 h treatment time thrice weekly ≥3 month
• Vascular access (fistula or graft) and high flow double lumen catheter which enables suitable effective blood flow rate (≥ 300 ml/min)

Exclusion Criteria

General:

• 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. 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 or lactation period
• Patient is not able to give informed consent according to MPG § 20 Sec. 2 Sentence 1 No. 1

Study-specific:

• Recurrent episodes of vascular access failure characterized by e.g. repeated cannulation problems or unstable blood flows within the last 2 months prior to study start (>3 times, respectively)
• Single needle treatments
• Catheter as vascular access (except high flow double lumen catheter)
• Unstable patients (due to e.g. acute intercurrent disease like myocardial infarction, cerebrovascular accident, peripheral arterial occlusion, active malignant disease, use of antibiotics within the last 4 weeks)
• Patients with heart failure (NYHA ≥ 3), COPD (GOLD 2-4), frequent intradialytic symptomatic hypotension requiring intervention within the last 2 months prior to study start (>3 times, respectively)
• Patients with known or suspected allergy to trial product and related products
• Patients with chronic antiallergic medication due to immune-mediated disease
• Planned absence from dialysis unit within the 4 weeks of study duration e.g. due to scheduled hospitalization, holidays or any other reason
• Active HBV, HCV, HIV infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Dr. Schauerte (IDS)

UNKNOWN

Sponsor Role: collaborator

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Götz Ehlerding, Dr med

Role: PRINCIPAL_INVESTIGATOR

Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

Locations

Diakonissenkrankenhaus Flensburg

Flensburg, , Germany

PHV-Dialysezentrum Goslar

Goslar, , Germany

Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

Hanover, , Germany

PHV Dialysezentrum Kiel

Kiel, , Germany

Countries

Germany

Other Identifiers

HD-FX-07-D

Identifier Type: -

Identifier Source: org_study_id