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Changes of albumin binding capacity during dialysis treatment sessions with Theranova dialyzers – short and midterm results

Changes of albumin binding capacity during dialysis treatment sessions with Theranova dialyzers – short and midterm results

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011638
Enrollment
32
Registered
2017-01-25
Start date
2016-12-31
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

N18.5

Interventions

Group 1: Chronic dialysis-dependet patients are treated once with the high-flux dialysis filter used to obtain baseline values. After that 7 treatments with the Theranova dialysis filter will be done.

Sponsors

Universitätsmedizin RostockKlinik für Innere Medizin II
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: at least 1 year dialysis; no dialysis associated incidents; safe vascular access; no acute or chronic infectious diseases; no hospital stay in the past 2 weeks; estimated life expectancy> 6 months; no patients with ongoing immunosuppression in post-natal transplantation; patient's consent

Exclusion criteria

Exclusion criteria: pregnancy

Design outcomes

Primary

MeasureTime frame
The main criterion is the characterization of the efficacy of Theranova filters in chronic dialysis patients with regard to the improvement of ABIC and the removal of uremia toxins.The test methods for determining albumin binding capacity (ABIC) were described by Klammt et al. (2008). The ABIC method determines the binding capacity of the Albumin molecule at the binding site II (Gambro-MARS, SPAD (single case albumin dialysis).) The ABIC also correlates inversely with the stage of renal insufficiency in patients with chronic kidney disease, ie, the higher the renal insufficiency the patient has, the worse the ABIC. On days 3, 8 and 22 blood samples are taken before and after the treatment.

Secondary

MeasureTime frame
The secondary objective is the correlation of further clinical and chemical parameters with the efficacy of the therapy. Are creatinine and urea affected as a surrogate parameter? Is there a positive influence on the protein and phosphate content?

Countries

Germany

Contacts

Public ContactSebastian Koball

Universitätsklinikum RostockZIM 1

sebastian.koball@med.uni-rostock.de0381 494 7339

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026