NCT01522794

Brief Summary

The purpose of this study is to assess the effect of the anti-hepcidin Spiegelmer 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 1, 2012

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

2 months

First QC Date

January 18, 2012

Last Update Submit

November 7, 2014

Conditions

Anemia of Chronic Disease

Outcome Measures

Primary Outcomes (1)

  • serum iron

    Change versus baseline; comparison of subjects treated with NOX-H94 versus placebo

    9 hours

Secondary Outcomes (8)

  • Pharmacodynamics: Effects of NOX-H94 on Iron homeostasis

    up to 2 Weeks

  • Pharmacokinetic profile of NOX-H94

    12 time points over 2 Weeks

  • Safety and tolerability

    up to 2 Weeks

  • Effects of NOX-H94 on innate immune response

    up to 2 weeks

  • Pharmacokinetics: Cmax of NOX-H94

    Day 1

  • +3 more secondary outcomes

Study Arms (2)

NOX-H94

EXPERIMENTAL

Single dose of NOX-H94

Drug: NOX-H94

Placebo

PLACEBO COMPARATOR

Single dose of placebo control

Drug: Placebo solution

Interventions

NOX-H94DRUG

single i.v. infusion

Also known as: lexaptepid pegol
NOX-H94
Placebo solutionDRUG

single i.v. infusion

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Use of any medication, recreational drugs or anti-oxidant vitamin supplements within 7 days
  • Use of caffeine, nicotine, or alcohol 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

  • van Eijk LT, John AS, Schwoebel F, Summo L, Vauleon S, Zollner S, Laarakkers CM, Kox M, van der Hoeven JG, Swinkels DW, Riecke K, Pickkers P. Effect of the antihepcidin Spiegelmer lexaptepid on inflammation-induced decrease in serum iron in humans. Blood. 2014 Oct 23;124(17):2643-6. doi: 10.1182/blood-2014-03-559484. Epub 2014 Aug 27.

    PMID: 25163699DERIVED

Related Links

MeSH Terms

Interventions

NOX-H94

Study Officials

  • Kai Riecke, MD

    TME Pharma AG

    STUDY DIRECTOR

  • Peter Pickkers, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

February 1, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

NL(1)