End-Stage Renal Disease (ESRD)CIEPO-PILOTNCT01526798
Improvement of EPO-resistance in Hemodialysis Patients With Chronic Inflammation by High Cut-off Hemodialysis
A study testing Theralite (high cut-off hemodialysis) and Conventional high-flux dialyzer in people with End-Stage Renal Disease (ESRD), run by Vantive Health LLC at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease (ESRD)
- What is being tested?
- Theralite (high cut-off hemodialysis) and Conventional high-flux dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Acute infection ≤4 weeks prior to randomization
- HIV or hepatitis infection
- Catheter
- Chronic liver disease
- Active cancer
- Known blood dyscrasia (paraprotein abnormalities)
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera Garbagnate Milanese Ospedale Bollate - Divisione Nefrologia e Dialisi
Bollate, Milan, 20021
About this study
Official title: Improvement of EPO-resistance in HD Patients With Chronic Inflammation by High Cut-off Hemodialysis - Pilot Study (CIEPO-PILOT)
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.
Read the 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.
- Conditions
- End-Stage Renal Disease (ESRD)
- Being tested
- Theralite (high cut-off hemodialysis), Conventional high-flux dialyzer
- Keywords
- End-Stage Renal Disease (ESRD), chronic Inflammation, EPO Resistance, ESA Resistance, high cut-off dialysis, hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theralite (high cut-off hemodialysis)Device
Hemodialysis with Theralite dialyzer alternating with standard high-flux dialyzer
Conventional high-flux dialyzerDevice
| Study group | Role | What they receive |
|---|---|---|
| Therlite hemodialysis | Experimental | Not described Receives: Device: Theralite (high cut-off hemodialysis) |
| Control group hfHDF | Active comparator | Control group hfHDF Receives: Device: Conventional high-flux dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythropoietin (EPO) resistance index
Weekly EPO dose in international units (IU) per kg body weight divided by hemoglobin value in g/dL
Measured: 12 weeks after randomization
Secondary outcomes (3)
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
Measured: baseline, 4, 8 and 12 weeks
Urea, Hepcidin, Free Light Chains, IL-6, IL-10
Pre- and post-dialysis concentration of urea, hepcidin
Measured: baseline, week 1
Albumin
Pre-dialysis albumin concentration during study period and follow-up
Measured: baseline, weeks 2,4,6,8,10,12,14,16,18,20,22,24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Ugo Teatini, Dr., Principal investigator, Azienda Ospedaliera Garbagnate Milanese Ospedale Bollate - Divisione Nefrologia e Dialisi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526798
- Sponsor's protocol ID
- No 1491 CIEPO-PILOT
- Acronym
- CIEPO-PILOT
- Status last verified
- Mar 2025
- First submitted
- 2 Feb 2012
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of EPO-resistance in HD Patients With Chronic Inflammation by High Cut-off Hemodialysis - Pilot Study (CIEPO-PILOT)
- ClinicalTrials.gov ID
- NCT01526798
- Acronym / sponsor ID
- CIEPO-PILOT / No 1491 CIEPO-PILOT
- Conditions
- End-Stage Renal Disease (ESRD)
- Keywords
- End-Stage Renal Disease (ESRD), chronic Inflammation, EPO Resistance, ESA Resistance, high cut-off dialysis, hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Gambro Dialysatoren GmbH, Baxter Healthcare Corporation
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therlite hemodialysis | Experimental | Device: Theralite (high cut-off hemodialysis) |
| Control group hfHDF | Active comparator | Device: Conventional high-flux dialyzerControl group hfHDF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- Acute infection ≤4 weeks prior to randomization
- HIV or hepatitis infection
- Catheter
- Chronic liver disease
- Active cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theralite (high cut-off hemodialysis)Hemodialysis with Theralite dialyzer alternating with standard high-flux dialyzer | Device | Therlite hemodialysis |
| Conventional high-flux dialyzer | Device | Control group hfHDF |
Primary outcome
Erythropoietin (EPO) resistance index
Time frame: 12 weeks after randomization
Weekly EPO dose in international units (IU) per kg body weight divided by hemoglobin value in g/dL
3 secondary outcomes
high sensitivity C-reactive protein (CRP), hepcidin, Free Light Chains (FLC), Interleukin (IL)-6, Interleukin (IL)-10
Time frame: baseline, 4, 8 and 12 weeks
Urea, Hepcidin, Free Light Chains, IL-6, IL-10
Time frame: baseline, week 1
Albumin
Time frame: baseline, weeks 2,4,6,8,10,12,14,16,18,20,22,24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ugo Teatini, Dr. principal investigator
Azienda Ospedaliera Garbagnate Milanese Ospedale Bollate - Divisione Nefrologia e Dialisi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theralite (high cut-off hemodialysis) and Conventional high-flux dialyzer in people with End-Stage Renal Disease (ESRD), run by Vantive Health LLC at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythropoietin (EPO) resistance index (time frame: 12 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.