Trial document




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  DRKS00003478

Trial Description

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Title

Randomized double blind placebo controlled PK/PD study on the effects of a single intravenous dose of NOX H94 on serum iron during experimental human endotoxemia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to assess the effect of the hepcidin-specific antagonist NOX-H94 on iron homeostasis during systemic inflammation induced by endotoxin.

In the human endotoxemia model, intravenously administered lipopolysaccharide elicits an inflammatory response with release of pro-inflammatory cytokines with subsequent induction of hepcidin. As a consequence of hepcidin induction, serum iron concentrations decrease.

This study in healthy subjects investigates the capacity of NOX-H94 to inactivate hepcidin and to prevent serum iron decrease in a pathophysiological model prior to studying the efficacy of NOX H94 in patients with anemia of chronic disease.

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Brief Summary in Scientific Language

The purpose of this study is to assess the effect of the hepcidin-specific antagonist NOX-H94 on iron homeostasis during systemic inflammation induced by endotoxin.

In the human endotoxemia model, intravenously administered lipopolysaccharide elicits an inflammatory response with release of pro-inflammatory cytokines, such as IL 6 and TNF-alfa, with subsequent induction of hepcidin. As a consequence of hepcidin induction, serum iron concentrations decrease.

This study in healthy subjects investigates the capacity of NOX-H94 to inactivate hepcidin and to prevent serum iron decrease in a pathophysiological model prior to studying the efficacy of NOX H94 in patients with anemia of chronic disease.

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Organizational Data

  •   DRKS00003478
  •   2012/01/25
  •   [---]*
  •   no
  •   Approved
  •   38191.091.11, Instituut Waarborging Kwaliteit en Veiligheid Commissie Mensgebonden Onderzoek regio Arnhem-Nijmegen
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Secondary IDs

  •   2011-005022-22 
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Health Condition or Problem studied

  •   10002073: Anaemia of chronic disease
  •   D63.8 -  Anaemia in other chronic diseases classified elsewhere
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Interventions/Observational Groups

  •   Single IV infusion of 1.2 mg/kg NOX-H94
  •   Single IV injection of Placebo
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   Placebo
  •   Treatment
  •   Parallel
  •   I
  •   N/A
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Primary Outcome

Serum iron: Change versus baseline; comparison of subjects treated with NOX-H94 versus placebo at 9h post LPS

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Secondary Outcome

Iron homeostasis (absolute and change vs. baseline): serum iron, transferrin saturation, ferritin, reticulocyte hemoglobin content, hemoglobin (Hb), mean cell volume, mean cell hemoglobin; Pharmacokinetic profile of NOX-H94; Safety and tolerability; Effects of NOX-H94 on innate immune response. Observation period: 2 weeks (Day 1, 2, 8, 15).

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Countries of Recruitment

  •   Netherlands
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/01/30
  •   24
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   35   Years
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Additional Inclusion Criteria

Main Inclusion Criteria:
- BMI between 18 and 30 kg/m², with a lower limit of body weight of 50 kg
- Healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters
- Serum iron and red blood parameters Hb, MCV, ferritin, serum iron, and total iron binding capacity within reference range

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Exclusion Criteria

Main Exclusion Criteria:
- Use of any medication, recreational drugs or anti-oxidant vitamin supplements within 7 days
- Use of caffeine, nicotine, or alcohol or within 1 day
- Previous participation in a trial where LPS was administered
- Surgery or trauma with significant blood loss or blood donation within 3 months
- History, signs or symptoms of cardiovascular disease (vaso-vagal collapse or of orthostatic hypotension, Resting pulse rate ≤45 or ≥100/min, Hypertension, Hypotension, ECG conduction abnormalities)
- Renal impairment: plasma creatinine >120 µmol/L
- Liver function tests (alkaline phosphatase, AST, ALT and γ-GT) outside of the reference range or total bilirubin >20 µmol/L
- Hemoglobin or iron parameters (iron, transferring saturation, ferritin) outside of the reference ranges
- History of asthma
- Immuno-deficiency
- Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies and HCV antibodies unless antibody titer is induced by vaccination
- CRP > reference range or clinically significant acute illness, including infections, within 2 weeks
- Treatment with investigational drugs or participation in any other clinical trial within 30 days prior to study drug administration
- Known or suspected of not being able to comply with the trial protocol
- Inability to personally provide written informed consent and/or take part in the study

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Addresses

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    • NOXXON Pharma AG
    • Max-Dohrn-Str. 8-10
    • 10589  Berlin
    • Germany
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    • NOXXON Pharma AG
    • Mr.  Dr. med.  Kai  Riecke 
    • Max-Dohrn-Str. 8-10
    • 10589  Berlin
    • Germany
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    • NOXXON Pharma AG
    • Mr.  Dr. med.  Kai  Riecke 
    • Max-Dohrn-Str. 8-10
    • 10589  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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    • NOXXON Pharma AG
    • Max-Dohrn-Str. 8-10
    • 10589  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/04/03
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.