Renal FailureGeniusNCT05282732
Retrospective Analysis of Performance and Treatment Data Collected for Genius SleddFlux Filter, Ultraflux AV 600 S Filter & Genius 90 Concentrates in Haemodialysis Patients
An observational study of Renal Failure and End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 3 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, End Stage Renal Disease, Acute Renal Failure
- How many people
- 119 participants
- Where
- 3 sitesGermany
- Study dates
- 7 Oct 2022to 15 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Haemodynamically instable patients in acute haemodialysis and chronic haemodialysis patients treatment with the Genius system
Who may be able to join
- 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
Who cannot join
- Simultaneous use of another filter/adsorber for another form of therapy
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Berlin, 12683
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Jena
Jena, 07743
About this study
Official title: 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
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
- Conditions
- Renal Failure, End Stage Renal Disease, Acute Renal Failure
- Keywords
- Hemodialysis, Genius system, Slow extended daily dialysis
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| aHD: Acute haemodialysis patients | Not described | |
| cHD: Chronic haemodialysis patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily values for urea, Unit: mg/dl or mmol/L
Acute haemodialysis patients
Measured: During the intervention
Daily values for creatinine, Unit: mg/dl or mmol/ or µmol/L
Acute haemodialysis patients
Measured: During the intervention
Daily values for potassium, Unit: mg/dl or mmol/ or µmol/L
Acute haemodialysis patients
Measured: During the intervention
Ultrafiltration volume (UF) and Effluent volume (per treatment)
Acute haemodialysis patients
Measured: During the intervention
Values for urea and creatinine (measured according to the clinical practice of the site)
Chronic haemodialysis patients
Measured: During the intervention
Planned and delivered UF-volume (per treatment)
Chronic haemodialysis patients
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start7 Oct 2022
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Medical Care Deutschland GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Responsible party
- Sponsor
- Investigators
- Martin Brauer, Dr. med., Principal investigator, Jena University HospitalBernhard Schmidt, Prof Dr med, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282732
- Sponsor's protocol ID
- Genius-AKI-01-D
- Acronym
- Genius
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05282732
- Acronym / sponsor ID
- Genius / Genius-AKI-01-D
- Conditions
- Renal Failure, End Stage Renal Disease, Acute Renal Failure
- Keywords
- Hemodialysis, Genius system, Slow extended daily dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Fresenius Medical Care Deutschland GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Alcedis GmbH
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 16 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aHD: Acute haemodialysis patients | – | – |
| cHD: Chronic haemodialysis patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Haemodynamically instable patients in acute haemodialysis and chronic haemodialysis patients treatment with the Genius system
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Simultaneous use of another filter/adsorber for another form of therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Daily values for urea, Unit: mg/dl or mmol/L
Time frame: During the intervention
Acute haemodialysis patients
Daily values for creatinine, Unit: mg/dl or mmol/ or µmol/L
Time frame: During the intervention
Acute haemodialysis patients
Daily values for potassium, Unit: mg/dl or mmol/ or µmol/L
Time frame: During the intervention
Acute haemodialysis patients
Ultrafiltration volume (UF) and Effluent volume (per treatment)
Time frame: During the intervention
Acute haemodialysis patients
Values for urea and creatinine (measured according to the clinical practice of the site)
Time frame: During the intervention
Chronic haemodialysis patients
Planned and delivered UF-volume (per treatment)
Time frame: During the intervention
Chronic haemodialysis patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Brauer, Dr. med. principal investigator
Jena University Hospital
Bernhard Schmidt, Prof Dr med principal investigator
Hannover Medical School
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure and End Stage Renal Disease, run by Fresenius Medical Care Deutschland GmbH at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily values for urea, Unit: mg/dl or mmol/L (time frame: During the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.