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Improvement of EPO-resistance in Hemodialysis Patients With Chronic Inflammation by High Cut-off Hemodialysis (CIEPO-PILOT)

Primary Purpose

End-Stage Renal Disease (ESRD)

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Theralite (high cut-off hemodialysis)
Conventional high-flux dialyzer
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-Stage Renal Disease (ESRD) focused on measuring End-Stage Renal Disease (ESRD), chronic Inflammation, EPO Resistance, ESA Resistance, high cut-off dialysis, hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Ospedaliera Garbagnate Milanese Ospedale Bollate - Divisione Nefrologia e Dialisi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therlite hemodialysis

Control group hfHDF

Arm Description

Control group hfHDF

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

high sensitivity C-reactive protein (CRP), hepcidin, Free Light Chains (FLC), Interleukin (IL)-6, Interleukin (IL)-10
Change in pre-dialysis concentration over study period
Urea, Hepcidin, Free Light Chains, IL-6, IL-10
Pre- and post-dialysis concentration of urea, hepcidin
Albumin
Pre-dialysis albumin concentration during study period and follow-up

Full Information

First Posted
February 2, 2012
Last Updated
April 19, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01526798
Brief Title
Improvement of EPO-resistance in Hemodialysis Patients With Chronic Inflammation by High Cut-off Hemodialysis
Acronym
CIEPO-PILOT
Official Title
Improvement of EPO-resistance in HD Patients With Chronic Inflammation by High Cut-off Hemodialysis - Pilot Study (CIEPO-PILOT)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Dialysatoren GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease (ESRD)
Keywords
End-Stage Renal Disease (ESRD), chronic Inflammation, EPO Resistance, ESA Resistance, high cut-off dialysis, hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therlite hemodialysis
Arm Type
Experimental
Arm Title
Control group hfHDF
Arm Type
Active Comparator
Arm Description
Control group hfHDF
Intervention Type
Device
Intervention Name(s)
Theralite (high cut-off hemodialysis)
Intervention Description
Hemodialysis with Theralite dialyzer alternating with standard high-flux dialyzer
Intervention Type
Device
Intervention Name(s)
Conventional high-flux dialyzer
Primary Outcome Measure Information:
Title
Erythropoietin (EPO) resistance index
Description
Weekly EPO dose in international units (IU) per kg body weight divided by hemoglobin value in g/dL
Time Frame
12 weeks after randomization
Secondary Outcome Measure Information:
Title
high sensitivity C-reactive protein (CRP), hepcidin, Free Light Chains (FLC), Interleukin (IL)-6, Interleukin (IL)-10
Description
Change in pre-dialysis concentration over study period
Time Frame
baseline, 4, 8 and 12 weeks
Title
Urea, Hepcidin, Free Light Chains, IL-6, IL-10
Description
Pre- and post-dialysis concentration of urea, hepcidin
Time Frame
baseline, week 1
Title
Albumin
Description
Pre-dialysis albumin concentration during study period and follow-up
Time Frame
baseline, weeks 2,4,6,8,10,12,14,16,18,20,22,24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ugo Teatini, Dr.
Organizational Affiliation
Azienda Ospedaliera Garbagnate Milanese Ospedale Bollate - Divisione Nefrologia e Dialisi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera Garbagnate Milanese Ospedale Bollate - Divisione Nefrologia e Dialisi
City
Bollate
State/Province
Milan
ZIP/Postal Code
20021
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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