NCT05282732 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fresenius Medical Care Deutschland GmbH |
| Condition | Renal Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-10-07 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-10-07 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Martin Brauer, Dr. med.
PRINCIPAL INVESTIGATOR
Jena University Hospital
Frequently Asked Questions
Who can join the NCT05282732 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05282732 currently recruiting?
Yes, NCT05282732 is actively recruiting participants. Contact the research team at Tatiana.De-Los-Rios@fmc-ag.com for enrollment information.
Where is the NCT05282732 trial being conducted?
This trial is being conducted at Hanover, Germany, Jena, Germany.
Who is sponsoring the NCT05282732 clinical trial?
NCT05282732 is sponsored by Fresenius Medical Care Deutschland GmbH. The principal investigator is Martin Brauer, Dr. med. at Jena University Hospital. The trial plans to enroll 100 participants.