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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Permeability Enhancement to Reduce Chronic Inflammation

NCT01582893

End Stage Renal Disease Inflammation

COMPLETED NA

High-cutoff Hemodialyzer to Reduce Chronic Inflammation in Hemodialysis Patients

NCT00974779

End Stage Renal Disease

COMPLETED PHASE2/PHASE3

Effect of a Medium Cut-Off Dialyzer - Medical Device on ESA Resistance in 110 Hemodialysis Patients (EXPAND)

NCT03874819

Hemodialysis Complication

UNKNOWN NA

Modulation of Vascular Calcification in Chronic Dialysis Patients

NCT03104166

Vascular Calcification

COMPLETED NA

Inflammation and Nutritional Parameters in Hemodialysis Patients Using Reprocessed Dialyzers

NCT00440908

End Stage Renal Disease Inflammation

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 activation markers etc. Chronic inflammation is linked to clinical signs and symptoms and cardiovascular mortality in dialysis patients. Inflamed dialysis patients show impaired response to erythropoiesis-stimulating agents (ESA) related to reduced iron utilization (functional iron deficiency) and elevated CRP levels are associated with a greater need for ESA to meet hemoglobin targets. If absolute iron deficiency can been excluded, EPO resistance is likely related to 'inflammatory block'.

The high molecular permeability of the Theralite high cut-off membrane allows for significant clearance of cytokines and other pro-inflammatory solutes by hemodialysis as shown in previous trials with high cut-off dialyzers. The study therefore aims to demonstrate that Theralite dialysis is effective in reducing chronic inflammation in ESRD patients, thereby improving EPO responsiveness. If this can be demonstrated, application of Theralite hemodialysis may reduce morbidity and mortality in the long term in ESRD patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End-Stage Renal Disease (ESRD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Therlite hemodialysis

Group Type EXPERIMENTAL

Theralite (high cut-off hemodialysis)

Intervention Type DEVICE

Hemodialysis with Theralite dialyzer alternating with standard high-flux dialyzer

Control group hfHDF

Group Type ACTIVE_COMPARATOR

Conventional high-flux dialyzer

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Theralite (high cut-off hemodialysis)

Hemodialysis with Theralite dialyzer alternating with standard high-flux dialyzer

Intervention Type DEVICE

Conventional high-flux dialyzer

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No