Ferinject® for Iron Deficiency in Idiopathic Pulmonary Arterial Hypertension (IPAH) Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01447628
First received: October 4, 2011
Last updated: July 22, 2014
Last verified: February 2012
  Purpose

This study will establish whether intravenous ferric carboxymaltose (Ferinject®)(iron) has clinical benefit in idiopathic pulmonary arterial hypertension.

A 24-week double-blind, randomised, placebo-controlled, crossover study will investigate whether a single dose of 1g of Ferinject® improves cardiopulmonary haemodynamics, exercise capacity and quality of life and is well-tolerated.


Condition Intervention Phase
Idiopathic Pulmonary Arterial Hypertension
Iron Deficiency
Drug: Saline
Drug: Ferinject
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: What is the Effect of Intravenous Iron Supplementation on Cardiopulmonary Haemodynamics, Exercise Capacity and Quality of Life in Patients With IPAH and Iron Deficiency?

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Change in resting pulmonary vascular resistance (PVR) [ Time Frame: 12 weeks from baseline ] [ Designated as safety issue: No ]
    To be measured by cardiac catheterisation


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ferinject Drug: Ferinject
Intravenous, 1000 mg iron
Placebo Comparator: Saline Drug: Saline
intravenous, no active drug

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females aged between 18-75 years old
  2. PAH which is idiopathic, heritable or associated with anorexigens.
  3. Iron deficiency as defined by any 3 of the following criteria:

    ferritin < 100 ug/l; transferrin saturations < 22.1%; EPO > 30.5 mIU/ml or 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:

    • 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).

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 with moderate to severe hypophosphatemia as defined as <0.65mmol/L
  5. Known to have haemoglobinopathy e.g. sickle cell disease, thalassaemia.
  6. Admission to hospital related to PAH or change in PAH therapy within 1 month prior to Screening.
  7. Evidence of left ventricular disease or significant lung disease on high-resolution CT scanning or lung function as judged by the investigator
  8. Acute or chronic infection or inflammation.
  9. Significant uncontrolled asthma as judged by the investigator, eczema or atopic allergies.
  10. Females who are lactating or pregnant.
  11. Individuals known to have HIV, Hepatitis B or C or Creutzfeld-Jakob disease.
  12. Known hypersensitivity to Ferinject® or any of its excipients.
  13. Evidence of disturbances in utilisation of iron.
  14. Significant blood loss (e.g. GI bleed) within the last 3 months or history of menorrhagia.
  15. Unable to perform a Cardiopulmonary Exercise Test i.e. due to syncope or musculoskeletal factors.
  16. Patients who have received an investigational medicinal product within 30 days of entering the baseline visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447628

Contacts
Contact: Luke Howard, DPhil, FRCP 020 8383 3171 l.howard@imperial.ac.uk
Contact: Vijay Zala, M.Pharm, MBA 020 8383 6103 V.Zala@imperial.ac.uk

Locations
United Kingdom
Papworth Hospital NHS Foundation Trust Recruiting
Cambridge, United Kingdom
Principal Investigator: Karen Sheares, PhD, FRCP         
Hammersmith Hospital, Imperial College NHS Trust Recruiting
London, United Kingdom
Principal Investigator: Luke Howard, DPhil, FRCP         
Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom
Principal Investigator: David Kiely, PhD, FRCP         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Luke Howard, DPhil, FRCP Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01447628     History of Changes
Other Study ID Numbers: CRO1811
Study First Received: October 4, 2011
Last Updated: July 22, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
idiopathic pulmonary arterial hypertension
iron deficiency

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Anemia, Iron-Deficiency
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014