NCT01526798

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

February 2, 2012

Last Update Submit

March 11, 2025

Conditions

End-Stage Renal Disease (ESRD)

Keywords

End-Stage Renal Disease (ESRD)chronic InflammationEPO ResistanceESA Resistancehigh cut-off dialysishemodialysis

Outcome Measures

Primary Outcomes (1)

  • Erythropoietin (EPO) resistance index

    Weekly EPO dose in international units (IU) per kg body weight divided by hemoglobin value in g/dL

    12 weeks after randomization

Secondary Outcomes (3)

  • high sensitivity C-reactive protein (CRP), hepcidin, Free Light Chains (FLC), Interleukin (IL)-6, Interleukin (IL)-10

    baseline, 4, 8 and 12 weeks

  • Urea, Hepcidin, Free Light Chains, IL-6, IL-10

    baseline, week 1

  • Albumin

    baseline, weeks 2,4,6,8,10,12,14,16,18,20,22,24

Study Arms (2)

Therlite hemodialysis

EXPERIMENTAL
Device: Theralite (high cut-off hemodialysis)

Control group hfHDF

ACTIVE COMPARATOR

Control group hfHDF

Device: Conventional high-flux dialyzer

Interventions

Theralite (high cut-off hemodialysis)DEVICE

Hemodialysis with Theralite dialyzer alternating with standard high-flux dialyzer

Therlite hemodialysis
Conventional high-flux dialyzerDEVICE
Control group hfHDF

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliera Garbagnate Milanese Ospedale Bollate - Divisione Nefrologia e Dialisi

Bollate, Milan, 20021, Italy

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ugo Teatini, Dr.

    Azienda Ospedaliera Garbagnate Milanese Ospedale Bollate - Divisione Nefrologia e Dialisi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2012

First Posted

February 6, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

March 13, 2025

Record last verified: 2025-03

Locations

IT(1)