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Clinical Trials/NCT02084381
NCT02084381
Completed
Not Applicable

Permeability Enhancement to Reduce Chronic Inflammation _ Medium Cut Off (MCO) (Study no 1502)

Vantive Health LLC2 sites in 1 country50 target enrollmentFebruary 2014
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ConditionsChronic Kidney FailureChronic Inflammation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Failure
Sponsor
Vantive Health LLC
Enrollment
50
Locations
2
Primary Endpoint
TNF-alpha mRNA
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The medium cut-off dialysis membrane has been developed to provide a significantly extended molecular cut-off compared to conventional high-flux membranes. The medium cut-off membrane allows for a high permeability of molecules up to a molecular weight of 45 kDa and has a still limited permeability for albumin (68 kDa).

The main goal of this project is the evaluation of the new, highly porous and selective dialysis membrane (MCO-Ci 400) for the treatment of patients with end-stage renal disease in hemodialysis mode and to study its potential to improve chronic inflammation.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
February 2015
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •CKD5 ( GFR \< 15ml/min/ 1.73m2)
  • •Dialysis treatment for ≥ 3 months
  • •Dialysis 3x weekly
  • •Vascular access by fistula or CVC
  • •Age \> 18 and \< 99 Years
  • •Ability to give written informed consent

Exclusion Criteria

  • •Missing informed consent form
  • •current clinically manifested infection or within the last two weeks
  • •current CRP-value \> 50mg/L or within the last two weeks
  • •Intake of any medication applied for immunosuppressive purposes
  • •Pregnancy or lactation
  • •Participation in a different interventional study

Outcomes

Primary Outcomes

TNF-alpha mRNA

Time Frame: 4 weeks treatment time

Significant lower pre- dialytic TNF-α mRNA expression level in circulating peripheral blood mononuclear cells

Secondary Outcomes

  • safety related events(6 month)

Study Sites (2)

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