Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane

NCT03315624 | Completed

• 1 other identifier: HD-FX-05-EU
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone membrane to obtain CE-certification according to the European Medical Device Directive for the FX Coral 600 (TD 16-1) dialyzer.

Conditions

Renal Failure; End Stage Renal Disease

Keywords

Hemodialysis; Hemodiafiltration; Renal replacement therapy

Outcome Measures

Primary Outcomes (1)

• Removal rate of 2-microglobulin

  Removal rate of 2-microglobulin will be calculated as primary endpoint in blood samples to evaluate the clinical performance of the new FX Coral 600 (TD 16-1) dialyzer.

  t=240 min. of HDF

Secondary Outcomes (3)

• Clearance of ß2-microglobulin

  t=60 min. of HDF

• Removal rates of myoglobin

  t=240 min. of HDF

• Clearances of myoglobin

  t= 60 min. 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 sessions with the dialyzer FX CORAL 600 (TD 16-1), the dialyzer FX CorDiax 600 or the dialyzer FX 600. In each week the patient is assigned to one type of dialyzer.

Device: Dialyzer

Interventions

Dialyzer DEVICE

Three hemodiafiltration sessions assigned to one type of dialyzer FX Coral 600, FX 600 and FX CorDiax 600

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
• Informed consent signed and dated by study patient and investigator / authorized physician
• Ability to understand the nature and requirements of the study

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 good 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 less or aged 55 years) or lactation period

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (1)

Georg-Haas-Dialysezentrum der PHV

Giessen, 35392, 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

• Stephan Wagner, Dr

  Georg-Haas-Dialysezentrum der PHV, Giessen, Germany

  PRINCIPAL INVESTIGATOR

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: October 10, 2017
• First Posted: October 20, 2017
• Study Start: October 6, 2017
• Primary Completion: December 9, 2017
• Study Completion: March 14, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

DE (1)