Comparison of Clinical Performance and Hemocompatibility of Dialyzers Applied During Post-dilution Online Hemodiafiltration

NCT04714281 | Completed

• 2 other identifiers: HD-FX-08-EUCIV-20-10-035024
• Study Type: interventional
• Target: 82
• Locations: 3 countries
• Sites: 8

Brief Summary

Comparison of the clinical performance and the hemocompatibility profile of different high-flux dialyzers, all applied during post-dilution online hemodiafiltration

Conditions

Renal Failure; End Stage Renal Disease

Keywords

Hemodialysis; Hemodiafiltration; Renal replacement therapy; Dialyzer

Outcome Measures

Primary Outcomes (1)

• Removal rate of β2-microglobulin

  Removal rate of β2-microglobulin will be calculated a primary endpoint in blood samples to evaluate the clinical Performance of the dialyzer FXCorAL

  t=240 minutes of HDF

Study Arms (1)

Hemodiafiltration HDF

OTHER

Three consecutive treatment periods of four weeks, one last study week where the patient is re-assigned to the same type of dialyzer used before beginning the study and one follow-up week per patient. Each treatment period includes 12 hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX CorAL 600 Fresenius Medical Care, comparator FX CorDiax 600 Fresenius Medical Care and comparator xevonta Hi 15 (B. Braun).

Device: Dialyser

Interventions

Dialyser DEVICE

Three consecutive treatment periods of four weeks, one last study week where the patient is re-assigned to the same type of dialyzer used before beginning the study and one follow-up week per patient. Each treatment period includes 12 hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX CorAL 600 Fresenius Medical Care, comparator FX CorDiax 600 Fresenius Medical Care and comparator xevonta Hi 15 (B. Braun).

Hemodiafiltration HDF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General:
• 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 her/his consent for participation in the clinical trial (cf. European Medical Device Directive and corresponding national regulations)
• 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
• Study-specific:
• On online post-dilution hemodiafiltration (HDF), at least 4 h treatment time thrice weekly with FX or FX CorDiax dialyzer ≥ 1 month
• Vascular access (fistula or graft) which enables blood flow rate ≥ 300 ml/min

You may not qualify if:

• 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 (pregnancy test will be conducted at start and end of study with female patients aged \< 55 years) or lactation period
• Patient is not able to give informed consent according to the European Medical Device Directive and corresponding national regulations
• 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)
• Repeated single needle treatments (\>3 times within the last 2 months prior to study start)
• Catheter as vascular access
• Unstable patients (due to e.g. acute intercurrent disease like cardiovascular infarction, decompensated heart failure, cerebrovascular accident, severe infection, active malignant disease)
• Patients with NYHA ≥ 3, COPD (GOLD 2-4), frequent intradialytic symptomatic hypotension
• Patients with known or suspected allergy to trial product and related products
• Patients with known inborn or acquired deficiencies of the innate and/or adaptive immune system
• Patients with acute (use within last 4 weeks) and/or chronic immunosuppressive medication e.g. due to immune-mediated disease including autoimmune diseases, transplantation, or cancer (oral and systemic corticosteroids, calcineurin and mTOR-inhibitors, immunosuppressive monoclonal antibodies, cytotoxic chemotherapy)

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead
• Institut Dr. Schauerte GmbH (IDS): collaborator

Study Sites (8)

Fresenius Nephrocare Nymburk

Nymburk, 288 02, Czechia

Location

Fresenius Nephrocare Praha 9 - Vysocany

Prague, 190 61, Czechia

Location

Diakonissenkrankenhaus Flensburg

Flensburg, 24939, Germany

Location

PHV-Dialysezentrum Goslar

Goslar, 38642, Germany

Location

Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

Hanover, 30625, Germany

Location

PHV Dialysezentrum Kiel

Kiel, 24106, Germany

Location

Péterfy II. Dialízis Központ

Budapest, 1077, Hungary

Location

Váci Dialízis Központ

Vác, 2600, Hungary

Location

Related Publications (1)

• Ehlerding G, Ries W, Kempkes-Koch M, Ziegler E, Ronova P, Krizsan M, Veresova J, Boke M, Erlenkotter A, Nitschel R, Zawada AM, Kennedy JP, Braun J, Larkin JW, Korolev N, Lang T, Ottillinger B, Stauss-Grabo M, Griesshaber B. Randomized investigation of increased dialyzer membrane hydrophilicity on hemocompatibility and performance. BMC Nephrol. 2024 Jul 10;25(1):220. doi: 10.1186/s12882-024-03644-5.

  PMID: 38987671 RESULT

Related Links

• Link to PubMed ID 38987671

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic

Interventions

Kidneys, Artificial

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Study Officials

• Götz Ehlerding, Dr med

  Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 19, 2021
• Study Start: February 3, 2021
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4); CZ (2); HU (2)