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

NCT03611218 | Completed

• 1 other identifier: HD-FX-06-D
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 6

Brief Summary

The clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration

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 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

Secondary Outcomes (3)

• Clearance of β2-microglobulin

  t=60 minutes of HDF

• Removal rate of α1-microglobulin

  t=240 minutes of HDF

• Clearance of α1-microglobulin

  t= 60 minutes of HDF

Study Arms (1)

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.

Device: Dialyzer

Interventions

Dialyzer DEVICE

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

Hemodiafiltration HDF

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (6)

Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

Hanover, Lower Saxony, 30453, Germany

Location

Diakonissenkrankenhaus Flensburg

Flensburg, 24939, Germany

Location

Georg-Haas-Dialysezentrum der PHV

Giessen, 35392, Germany

Location

PHV-Dialysezentrum Goslar

Goslar, 38642, Germany

Location

PHV Dialysezentrum Kiel

Kiel, 24106, Germany

Location

PHV-Dialysezentrum Lauterbach

Lauterbach, 36341, Germany

Location

Related Publications (1)

• 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.

  PMID: 35373083 DERIVED

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 Design

• Study Type: interventional
• Phase: not applicable
• 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: July 27, 2018
• First Posted: August 2, 2018
• Study Start: August 29, 2018
• Primary Completion: December 8, 2018
• Study Completion: December 8, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

DE (6)