Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration

NCT04102280 | Completed

• 1 other identifier: HD-FX-07-D
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

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.

Conditions

Renal Failure; End Stage Renal Disease

Keywords

Hemodialysis; Hemodiafiltration; Renal replacement therapy

Outcome Measures

Primary Outcomes (1)

• Removal rate of β2-microglobulin

  Removal rate of β2-microglobulin in Plasma related to the albumin removal into the dialysate

  t=240 minutes of HDF

Study Arms (1)

Hemodiafiltration HDF

OTHER

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)

Device: Dialyser

Interventions

Dialyser 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)

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:
• 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)

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 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

Sponsors & Collaborators

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

Study Sites (4)

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

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: September 23, 2019
• First Posted: September 25, 2019
• Study Start: October 29, 2019
• Primary Completion: November 6, 2020
• Study Completion: May 26, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Locations

DE (4)