search
Back to results

Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration (eMPORA II)

Primary Purpose

Renal Failure, End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Dialyzer
Sponsored by
Fresenius Medical Care Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

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
  • 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

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 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

Sites / Locations

  • Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
  • Diakonissenkrankenhaus Flensburg
  • Georg-Haas-Dialysezentrum der PHV
  • PHV-Dialysezentrum Goslar
  • PHV Dialysezentrum Kiel
  • PHV-Dialysezentrum Lauterbach

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hemodiafiltration HDF

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clearance of β2-microglobulin
Removal rate of α1-microglobulin
Clearance of α1-microglobulin

Full Information

First Posted
July 27, 2018
Last Updated
December 18, 2018
Sponsor
Fresenius Medical Care Deutschland GmbH
search

1. Study Identification

Unique Protocol Identification Number
NCT03611218
Brief Title
Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration
Acronym
eMPORA II
Official Title
Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration - eMPORA II Study (Modified POlysulfone membRAne)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 29, 2018 (Actual)
Primary Completion Date
December 8, 2018 (Actual)
Study Completion Date
December 8, 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 compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration
Detailed Description
The primary objective of this study is to test whether the new FX P600 (applied during post-dilution online HDF) is non-inferior to two comparator dialyzers (Sureflux-17UX (Nipro) and Polyflux 170 H (Baxter/Gambro) in removing β2-microglobulin. The secondary objective is to exploratively compare the efficacy in removing other uremic solutes between the new FX P600 and the Sureflux-17UX as well as the Polyflux 170 H membranes. Additionally, the safety of the FX P600 dialyzer with a modified polysulfone membrane will be investigated.

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
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemodiafiltration HDF
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dialyzer
Intervention Description
Three hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H
Primary Outcome Measure Information:
Title
Removal rate of β2-microglobulin
Description
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.
Time Frame
t=240 minutes of HDF
Secondary Outcome Measure Information:
Title
Clearance of β2-microglobulin
Time Frame
t=60 minutes of HDF
Title
Removal rate of α1-microglobulin
Time Frame
t=240 minutes of HDF
Title
Clearance of α1-microglobulin
Time Frame
t= 60 minutes 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 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 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 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
Facility Information:
Facility Name
Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30453
Country
Germany
Facility Name
Diakonissenkrankenhaus Flensburg
City
Flensburg
ZIP/Postal Code
24939
Country
Germany
Facility Name
Georg-Haas-Dialysezentrum der PHV
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
PHV-Dialysezentrum Goslar
City
Goslar
ZIP/Postal Code
38642
Country
Germany
Facility Name
PHV Dialysezentrum Kiel
City
Kiel
ZIP/Postal Code
24106
Country
Germany
Facility Name
PHV-Dialysezentrum Lauterbach
City
Lauterbach
ZIP/Postal Code
36341
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
35373083
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs