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

End Stage Renal Disease Clinical Trial

— eMPORA  

Official title:

Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane - eMPORA Study (Modified POlysulfone membRAne)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315624
• Other study ID #: HD-FX-05-EU
• Status: Completed
• Phase: N/A
• First received: October 10, 2017
• Last updated: March 28, 2018
• Start date: October 6, 2017
• Est. completion date: March 14, 2018

Study information

• Verified date: March 2018
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The FX Coral (TD 16-1) dialyzer is a new development with a modified polysulfone membrane and is not CE marked yet. The purpose of the clinical evaluation is to generate clinical data for the CE approval.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 14, 2018
• Est. primary completion date: December 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Renal Failure
• Renal Insufficiency

Intervention

Device:
• Dialyzer
Three hemodiafiltration sessions assigned to one type of dialyzer FX Coral 600, FX 600 and FX CorDiax 600

Locations

Country	Name	City	State
Germany	Georg-Haas-Dialysezentrum der PHV	Gießen

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clearance of ß2-microglobulin		t=60 min. of HDF
Secondary	Removal rates of myoglobin		t=240 min. of HDF
Secondary	Clearances of myoglobin		t= 60 min. of HDF