Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006410

Trial Description

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Title

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

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Trial Acronym

PERCI-MCO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006410
  •   2014/12/02
  •   2014/02/07
  •   no
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Secondary IDs

  •   NCT02084381  (ClinicalTrials.gov)
  •   1502  (Gambro Dialysatoren GmbH)
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Health Condition or Problem studied

  •   Chronic Kidney Failure
  •   Chronic Inflammation
  •   N18.5 -  Chronic kidney disease, stage 5
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Interventions/Observational Groups

  •   Device: MCO-Ci 400
  •   Device: Revaclear 400
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
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Primary Outcome

- TNF-alpha mRNA; time frame: 4 weeks treatment time; Significant lower pre- dialytic TNF-α mRNA expression level in circulating peripheral blood mononuclear cells

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Secondary Outcome

- safety related events; time frame: 6 month

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
  •  
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Recruitment

  •   [---]*
  •   2014/02/27
  •   50
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Baxter Healthcare Corporation
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    • German Federal Ministry of Education and Research
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    • Gambro Dialysatoren GmbH
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    • Martin-Luther-Universität Halle-Wittenberg
    • Matthias Girndt, Prof. Dr. 
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    • Martin-Luther-Universität Halle-Wittenberg
    • Matthias Girndt, Prof. Dr. 
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    •   [---]*
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/01
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2018/11/30
* This entry means the parameter is not applicable or has not been set.