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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2010-023233-30-NL |
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Date of registration:
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06/10/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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‘Intravenous iron treatment in iron deficient patients with pulmonary arterial
hypertension' - Treating iron deficiency in PAH
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Scientific title:
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‘Intravenous iron treatment in iron deficient patients with pulmonary arterial
hypertension' - Treating iron deficiency in PAH |
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Date of first enrolment:
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13/12/2010 |
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Target sample size:
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30 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023233-30 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Stable idiopathic pulmonary arterial hypertension (stable disease for at least 3 months)
- iron deficiency (serum iron below 10 µmol/l, decreased transferrin saturation (<15% in females and <20% in males) and serum ferritin <100 µg/l) irrespective of the coexistence of anaemia
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Current iron therapy (oral or iv)
- Current other study medication for PAH
- History of anaemia or current treatment of anaemia
- Liver function impairment
- Chronic disease other than PAH ( rheumatism, asthma, chronic infection)
- Acute infection
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Objective: To evaluate the effects of intravenous iron suppletion in iron deficient IPAH patients.
Study design: Intervention study
Study population: Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency
Intervention:
Patients receive a weekly iron bolus infusion until iron levels are restored (correction phase). Then a maintenance dose is given once per month (maintenance phase) until the endpoint after 20 weeks.
MedDRA version: 12.1
Level: LLT
Classification code 10064909
Term: Idiopathic (IPAH)
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Intervention(s)
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Trade Name: Ferinject
Product Name: Ferric carboxymaltose
Product Code: RVG 33865
Pharmaceutical Form: Solution for injection
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Primary Outcome(s)
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Secondary Objective: To observe the effects of intravenous iron suppletion on exercise capacity in IPAH patients
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Primary end point(s): Effects on six-minute walking distance tests of intravenous iron.
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Main Objective: To evaluate the effects of intravenous iron suppletion in iron deficient IPAH patients.
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Secondary ID(s)
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NL33043.029.10
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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