Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients

NCT ID: NCT05282732

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-07

Study Completion Date

2025-12-31

Brief Summary

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Retrospective analysis of performance and treatment data collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter \& Genius 90 Concentrates in acute haemodialysis, haemodynamically instable patients and chronic haemodialysis patients

* to analyse performance and treatment data from patients treated with the investigational device
* to evaluate the filter characteristics for aHD (Acute haemodialysis) patients
* to evaluate the improvement of kidney function for aHD patients

Detailed Description

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Conditions

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Renal Failure End Stage Renal Disease Acute Renal Failure

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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aHD: Acute haemodialysis patients

No interventions assigned to this group

cHD: Chronic haemodialysis patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients with an indication for the extracorporeal blood treatment suffering from renal insufficiency who received all treatments, between January 2019 and December 2019, with the investigational devices have to be included in the study in chronological order.
* For aHD patients: availability of at least 3 of the 5 primary variables (daily urea, creatinine, potassium, ultrafiltration and effluent volume) for 50 % of the documented treatments.
* For cHD patients: availability of the ultrafiltration values for all treatments and at least one value for urea and creatinine per week

Exclusion Criteria

* Simultaneous use of another filter/adsorber for another form of therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcedis GmbH

INDUSTRY

Sponsor Role collaborator

Fresenius Medical Care Deutschland GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Brauer, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Jena University Hospital

Bernhard Schmidt, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Locations

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Medizinische Hochschule Hannover

Hanover, , Germany

Site Status RECRUITING

Universitätsklinikum Jena

Jena, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Tatiana De los Rios

Role: CONTACT

+49 6172 608 2362

Jana Schmitt

Role: CONTACT

+49 6172 609 95403

Facility Contacts

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Bernhard Schmidt, Prof.Dr.

Role: primary

Brauer Martin, Dr.

Role: primary

Other Identifiers

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Genius-AKI-01-D

Identifier Type: -

Identifier Source: org_study_id

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