Improvement of EPO-resistance in Hemodialysis Patients With Chronic Inflammation by High Cut-off Hemodialysis

About this trial

Last updated a year ago

Study ID

No 1491 CIEPO-PILOT

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended 14 years ago

What is this trial about?

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 to demonstrate that high cut-off hemodialysis is effective in reducing chronic inflammation and thereby improving response to ESAs.

What are the participation requirements?

Inclusion Criteria

* 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 Criteria

* 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