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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01526798
Other study ID # No 1491 CIEPO-PILOT
Secondary ID
Status Completed
Phase N/A
First received February 2, 2012
Last updated April 19, 2017
Start date March 2012
Est. completion date November 2012

Study information

Verified date March 2017
Source Baxter Healthcare Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Theralite (high cut-off hemodialysis)
Hemodialysis with Theralite dialyzer alternating with standard high-flux dialyzer
Conventional high-flux dialyzer


Locations

Country Name City State
Italy Azienda Ospedaliera Garbagnate Milanese Ospedale Bollate - Divisione Nefrologia e Dialisi Bollate Milan

Sponsors (2)

Lead Sponsor Collaborator
Baxter Healthcare Corporation Gambro Dialysatoren GmbH

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 baseline, 4, 8 and 12 weeks
Secondary Urea, Hepcidin, Free Light Chains, IL-6, IL-10 Pre- and post-dialysis concentration of urea, hepcidin baseline, week 1
Secondary Albumin Pre-dialysis albumin concentration during study period and follow-up baseline, weeks 2,4,6,8,10,12,14,16,18,20,22,24
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