EUCTR2010-024585-22-DEActive, not recruitingPhase 1
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
Imperial College Academic Healthsciences Centre0 sites60 target enrollmentStarted: August 17, 2016Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •The following entry criteria have to be chosen carefully 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 anorexigens.
- •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. 6 minute walking distance greater than 50m 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:
- •Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- •o intravaginal
- •o transdermal
- •Progestogen-only hormonal contraception associated with inhibition of ovulation:
- •o injectable
- •o implantable
- •Intrauterine device (IUD)
- •Intrauterine hormone-releasing system (IUS)
- •Bilateral tubal occlusion
- •Vasectomised partner
- •Sexual abstinence
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •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 will be excluded if any single parameter (iron, ferritin or transferritin saturation) exceeds 1x upper limit of normal (ULN) in the local lab reference range
- •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 as judged by the investigator
- •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 Creutzfeld-Jakob disease.
- •13. Known hypersensitivity to FerinjectP®P or any of its excipients and any other iron supplement preparation.
- •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
Investigators
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