Status:
COMPLETED
Improvement of EPO-resistance in Hemodialysis Patients With Chronic Inflammation by High Cut-off Hemodialysis
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Gambro Dialysatoren GmbH
Baxter Healthcare Corporation
Conditions:
End-Stage Renal Disease (ESRD)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic inflammation in dialysis patients is linked to cardiovascular mortality and clinical signs and symptoms, like the impaired response to erythropoiesis-stimulating agents (ESAs). This study aims...
Detailed Description
Chronic inflammation in hemodialysis patients (micro-inflammation) is caused by multiple inflammatory stimuli and becomes apparent by elevated levels of biochemical markers such as CRP, IL-6, cellular...
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 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)
Exclusion
- Acute infection ≤4 weeks prior to randomization
- HIV or hepatitis infection
- Catheter
- 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
- Planned transplantation within study period +3 months
- Planned interventions requiring hospitalization \>1 week
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01526798
Start Date
March 1 2012
End Date
November 1 2012
Last Update
March 13 2025
Active Locations (1)
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1
Azienda Ospedaliera Garbagnate Milanese Ospedale Bollate - Divisione Nefrologia e Dialisi
Bollate, Milan, Italy, 20021