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Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane (eMPORA)

Primary Purpose

Renal Failure, End Stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Dialyzer

About this trial

This is an interventional treatment trial for Renal Failure focused on measuring Hemodialysis, Hemodiafiltration, Renal replacement therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Georg-Haas-Dialysezentrum der PHV

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hemodiafiltration HDF

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clearance of ß2-microglobulin

Removal rates of myoglobin

Clearances of myoglobin

Full Information

NCT ID

NCT03315624

First Posted

October 10, 2017

Last Updated

March 28, 2018

Sponsor

Fresenius Medical Care Deutschland GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03315624

Brief Title

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

Acronym

eMPORA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

October 6, 2017 (Actual)

Primary Completion Date

December 9, 2017 (Actual)

Study Completion Date

March 14, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fresenius Medical Care Deutschland GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Failure, End Stage Renal Disease

Keywords

Hemodialysis, Hemodiafiltration, Renal replacement therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

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

Masking

None (Open Label)

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hemodiafiltration HDF

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Dialyzer

Intervention Description

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

Primary Outcome Measure Information:

Title

Removal rate of 2-microglobulin

Description

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.

Time Frame

t=240 min. of HDF

Secondary Outcome Measure Information:

Title

Clearance of ß2-microglobulin

Time Frame

t=60 min. of HDF

Title

Removal rates of myoglobin

Time Frame

t=240 min. of HDF

Title

Clearances of myoglobin

Time Frame

t= 60 min. of HDF

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephan Wagner, Dr

Organizational Affiliation

Georg-Haas-Dialysezentrum der PHV, Giessen, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Georg-Haas-Dialysezentrum der PHV

City

Gießen

ZIP/Postal Code

35392

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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