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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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1 February 2020 |
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Main ID: |
EUCTR2010-024585-22-GB |
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Date of registration:
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25/02/2011 |
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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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What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?
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Scientific title:
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What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency? - Ferinject® for iron deficiency in IPAH patients |
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Date of first enrolment:
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25/03/2011 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-024585-22 |
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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: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Germany
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
We have carefully chosen the following entry criteria to clearly define our study group and reduce the potential for variation.
1. Males or females aged between 16–75 years old
2. PAH which is idiopathic, heritable or associated with anorexogens.
3. Iron deficiency as defined by any one of the following criteria:
sTfR levels > 28.1 nmol/l (where sTfR analysis is available) or one of the following: Ferritin < 37 ug/l; transferrin saturations < 16.4%; iron < 10.3 umol/l.
4*. Documented diagnosis of PAH by right heart catheterisation performed at any time prior to Screening showing: resting mean pulmonary artery pressure >25mmHg, pulmonary capillary wedge pressure =/< 15 mm Hg and normal or reduced cardiac output.
5. Six minute walking distance greater than 150m at entry;
6. Stable on an unchanged PAH therapeutic regime (any combination of endothelin receptor antagonist, phosphodiesterase inhibitor or prostacyclin analogue) for at least 1 month.
7. Able to provide written informed consent prior to any study-mandated procedures.
8. Female subjects of child-bearing potential are eligible to participate if they agree to use one of the following contraception methods:
- Abstinence
- Contraceptive methods with a failure rate of < 1%:
- Oral contraceptive, either combined or progestogen alone;
- Injectable progestogen;
- Implants of levonorgestrel;
- Estrogenic vaginal ring;
- Percutaneous contraceptive patches;
- Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label;
- Male partner(s) sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study;
- Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus vaginal spermicidal agent (foam/gel/film/cream/suppository).
*Patients who have not had a cardiac catheterisation prior to screening, but meet all other inclusion/exclusion criteria will be considered for the study if the clinical diagnosis is in keeping with idiopathic pulmonary arterial hypertension (IPAH). Inclusion of such patients should be discussed with the CI. These patients will be excluded at baseline if during the right heart catheterisation (RHC) the following criteria are not met: resting mean pulmonary artery pressure > 25mm Hg, pulmonary capillary wedge pressure =/< 15 mm Hg and normal or reduced cardiac output.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Exclusion criteria:
1. Unable to provide informed consent.
2. Clinically-significant renal disease (Creatinine clearance < 30 ml/min per 1.73 m2 calculated from CKD-Epi http://www.qxmed.com/renal/Calculate-CKD-EPI-GFR.php) or liver disease (including serum transaminases > 3 times upper limit of normal).
3. Haemoglobin concentration <10 g/dl.
4. Patients who meet any of the following criteria will be excluded:
Iron>27 umol/L, Ferritin>300 ug/L or Transferrin saturations >45%
5. Patients with moderate to severe hypophosphatemia as defined as <0.65mmol/L
6. Known to have haemoglobinopathy e.g. sickle cell disease, thalassaemia.
7. Admission to hospital related to PAH or change in PAH therapy within 1 month prior to Screening.
8. Evidence of left ventricular disease or significant lung disease on high-resolution CT scanning or lung function.
9. Acute or chronic infection or inflammation.
10. Significant uncontrolled asthma as judged by the investigator, eczema or atopic allergies.
11. Females who are lactating or pregnant.
12. Individuals known to have HIV, Hepatitis B or C or Creutzfeldt-Jakob disease.
13. Known hypersensitivity to Ferinject® or any of its excipients.
14. Evidence of disturbances in utilisation of iron.
15. Significant blood loss (e.g. GI bleed) within the last 3 months or history of menorrhagia.
16. Unable to perform a Cardiopulmonary Exercise Test i.e. due to syncope or musculoskeletal factors.
17. Patients who have received an investigational medicinal product within 30 days of entering the baseline visit
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Idiopathic or familial pulmonary arterial hypertension
MedDRA version: 18.0
Level: PT
Classification code 10037400
Term: Pulmonary hypertension
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
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Intervention(s)
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Trade Name: Ferinject
Product Name: Ferinject
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ferric carboxymaltose
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: 12 weeks
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Primary end point(s): The change in resting pulmonary vascular resistance (PVR) between baseline and 12 weeks, measured by cardiac catheterisation.
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Main Objective: To assess the clinical value of using intravenous iron (ferric carboxymaltose) infusion in iron deficient patients with idiopathic pulmonary arterial hypertension.
The primary endpoint will be the change in the resistance to blood flow through the lungs (resting pulmonary vascular resistance), measured by cardiac catheterisation at baseline and 12 weeks after the initial infusion.
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Secondary Objective: It is possible that iron may have beneficial effects via mechanisms not directly related to the blood flow through the lungs. Capturing other data, particularly exercise capacity, on the study participants is therefore essential. These non-invasive tests will be repeated to detect evidence of early benefit (at 2 weeks) as well as to follow serial changes in exercise capacity and iron status (at 12, 14, and 24 weeks after the initial infusion).
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 24 weeks
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Secondary end point(s): • Incremental bicycle cardiopulmonary exercise testing - peak VO2 (ml/min/kg), VO2 at metabolic threshold, VE/VCO2 slope, VO2/WR slope, O2 pulse and tissue oxygenation index (at Hammersmith Site).
• Endurance time on bicycle cardiopulmonary exercise test at 80% peak work rate, with measurement of steady-state gas exchange and tissue oxygenation index (Hammersmith Site only) at 3 minutes and peak
• Resting cardiopulmonary haemodynamics – right atrial pressure, pulmonary arterial pressure, pulmonary capillary wedge pressure, cardiac output and stroke volume
• Exercise cardiopulmonary haemodynamics (at a work rate equivalent to 40% peak VO2) - pulmonary arterial pressure, pulmonary capillary wedge pressure, cardiac output and stroke volume
• Iron indices – serum iron, transferrin saturations, ferritin, soluble transferrin receptor (sTfR), unsaturated iron binding capacity (UIBC), red cell distribution width (RDW) and erythropoietin (EPO) levels
• 6 minute walk distance and Borg dyspnoea scale
• NYHA WHO functional class
• NT-pro-BNP
• Quality of life (CAMPHOR questionnaire) and the self-reported Patient Global Assessment
• Safety - the occurrence of adverse events
• Cardiac MRI - right ventricular volumes, mass, ejection fraction, stroke volume and diastolic function (at Hammersmith and Sheffield only)
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 24/02/2011
Contact:
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