Status:
UNKNOWN
Effect of a Medium Cut-Off Dialyzer - Medical Device on ESA Resistance in 110 Hemodialysis Patients (EXPAND)
Lead Sponsor:
Carlo Maria Guastoni
Conditions:
Hemodialysis Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
It is hypothesized that a consistent use of Medium cut-off membrane (Theranova) increased clearance of pro-inflammatory molecules in a broad molecular weight range attenuates the chronic inflammatory ...
Detailed Description
Hemodialysis Patients present chronic inflammation caused by multiple inflammatory stimuli. Chronic inflammation is linked to clinical signs and symptoms and cardiovascular mortality in these patients...
Eligibility Criteria
Inclusion
- ESRD treated with chronic HD for at least 3 months
- Treatment with high flux dialyzers for at least 3 months
- Age ≥18 years
- Receiving intravenous short acting ESA to treat anemia for at least 3 months
- Impaired ESA responsiveness as indicated by EPO resistance index \>median of patients in study center
- transferrin saturation (TSAT) ≥20% (last routine value prior to randomization)
- serum ferritin ≥100 ng/ml (last routine value prior to randomization)
- Signed informed consent.
Exclusion
- Acute infection ≤4 weeks prior to randomization
- HIV or hepatitis infection
- Central Venous Catheter (with the history of infections in the latest 3 months)
- chronic liver disease
- active cancer
- known blood dyscrasia (paraprotein abnormalities)
- known bleeding disorders
- Bleeding episode ≤12 weeks prior to randomization
- Blood/red cell transfusion ≤12 weeks prior to randomization
- hypoalbuminemia defined as serum albumin concentration below 35 g/L
- (last routine value prior to randomization)
- Participation in another clinical interventional investigation
- Pregnancy
- Inability to give informed consent.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2020
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03874819
Start Date
July 15 2019
End Date
March 15 2020
Last Update
July 8 2019
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