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

NCT03874819 | Unknown DMC

• 1 other identifier: EXPAND
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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 state in patients with poor response to ESA therapy and absence of absolute iron deficiency and that this leads to an improvement in ESA responsiveness (EPO resistance index).

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

• Change of the "Erythropoietin Responsiveness factor" (EPO index)

  EPO index will be calculated as the average weekly EPO dose in IU per kg BW in the preceding 4 weeks divided by the last measured Hb

  Up to 48 weeks

Secondary Outcomes (2)

• Inflammation status

  Up to 48 weeks

• Metabolic diseases

  Up to 48 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

Conventional Hemodialysis using a high-flux dialyzer

Device: High-flux dialyzer

Experimental group

EXPERIMENTAL

Conventional Hemodialysis using a medium cut-of dialyzer

Device: Medium cut-off dialyzer

Interventions

Medium cut-off dialyzer DEVICE

Treatment using a Medium Cut-Off Dialyzer

Experimental group

High-flux dialyzer DEVICE

Treatment using a high-flux dialyzer

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carlo Maria Guastoni: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Operative Unit of Dialysis and Nephrology

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 14, 2019
• Study Start: July 15, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: July 8, 2019

Record last verified: 2019-07