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
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure focused on measuring Hemodialysis, Hemodiafiltration, Renal replacement therapy
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
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.
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
No
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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