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Randomised crossover trial of a porous haemodialysis membrane compared to a conventional high-flux membrane in stable haemodialysis patients to determine the short term impact on inflammatory and nutritional indices.

Randomised crossover trial of a porous haemodialysis membrane compared to a conventional high-flux membrane in stable haemodialysis patients to determine the short term impact on inflammatory and nutritional indices.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12606000132549
Acronym
Nil
Enrollment
30
Registered
2006-04-11
Start date
2006-06-30
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This trial examines whether a new dialysis membrane has potential advantages to the patients by way of determining whether the membrane results in less of an inflammatory state - reflected by both markers of inflammation and nutrition in the blood. It is a short term pilot study only, as a possible lead in to a longer more detailed study. The dialysis membranes will be supplied blinded in that all will look the same (but carry a code) such that the treating dialysis nurses and the patients will be unaware of which dialyser is in use at any given time.

Interventions

30 stable haemodialysis patients will be randomly assigned to either continue on conventional high-flux dialysis with the FX60 membrane or the new modified-FX membrane. Equal numbers in each group. Cross-over after 6 weeks. Total study duration 12 weeks.

Sponsors

Fresenius
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Stable haemodialysis patients, currently dialysed with FX60 dialysers.

Exclusion criteria

No exclusion criteria

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026