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

NCT05282732 | Recruiting

• 1 other identifier: Genius-AKI-01-D
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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 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

Outcome Measures

Primary Outcomes (6)

• Daily values for urea, Unit: mg/dl or mmol/L

  Acute haemodialysis patients

  During the intervention

• Daily values for creatinine, Unit: mg/dl or mmol/ or µmol/L

  Acute haemodialysis patients

  During the intervention

• Daily values for potassium, Unit: mg/dl or mmol/ or µmol/L

  Acute haemodialysis patients

  During the intervention

• Ultrafiltration volume (UF) and Effluent volume (per treatment)

  Acute haemodialysis patients

  During the intervention

• Values for urea and creatinine (measured according to the clinical practice of the site)

  Chronic haemodialysis patients

  During the intervention

• Planned and delivered UF-volume (per treatment)

  Chronic haemodialysis patients

  During the intervention

Study Arms (2)

aHD: Acute haemodialysis patients

cHD: Chronic haemodialysis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Haemodynamically instable patients in acute haemodialysis and chronic haemodialysis patients treatment with the Genius system

You may qualify if:

• 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

You may not qualify if:

• Simultaneous use of another filter/adsorber for another form of therapy

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead
• Alcedis GmbH: collaborator

Study Sites (2)

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Universitätsklinikum Jena

Jena, 07743, Germany

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Brauer, Dr. med.

  Jena University Hospital

  PRINCIPAL INVESTIGATOR

• Bernhard Schmidt, Prof Dr med

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana De los Rios

CONTACT

+49 6172 608 2362; Tatiana.De-Los-Rios@fmc-ag.com

Jana Schmitt

CONTACT

+49 6172 609 95403; Jana.Schmitt@fmc-ag.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 16, 2022
• Study Start: October 7, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

DE (2)