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NCT Number: NCT05282732

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

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Key information

Conditions

Renal Failure Acute Kidney Injury Acute Renal Failure Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Hochschule Hannover, Hanover, Germany

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: During the intervention

    Acute haemodialysis patients

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

    Time frame: During the intervention

    Acute haemodialysis patients

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

    Time frame: During the intervention

    Acute haemodialysis patients

  4. Ultrafiltration volume (UF) and Effluent volume (per treatment)

    Time frame: During the intervention

    Acute haemodialysis patients

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

    Time frame: During the intervention

    Chronic haemodialysis patients

  6. Planned and delivered UF-volume (per treatment)

    Time frame: During the intervention

    Chronic haemodialysis patients

Study contacts

Contact information is provided by the study sponsor or research team.

Jana Schmitt

CONTACT

[email protected]

+49 6172 609 95403

Tatiana De los Rios

CONTACT

[email protected]

+49 6172 608 2362

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Collaborators

  • Alcedis GmbH

Registry information

Official study 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

Acronym: Genius

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2022
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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