Oral iron supplementation with ferric maltol in patients with Pulmonary Hypertension

A pilot Study to explore safety, tolerability and efficacy of ORal IrON supplementation with ferric maltol in treating iron deficiency in patients with pulmonary hypertension and iron deficiency anemia - ORION-PH-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-005100-26-DE

Enrollment

Registered

2017-07-07

Start date

2017-10-09

Completion date

Unknown

Last updated

2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with iron deficiency anemia and pulmonary hypertension MedDRA version: 20.0 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851 MedDRA version: 20.0 Level: HLT Classification code 10037401 Term: Pulmonary hypertensions System Organ Class: 100000004855

Interventions

Trade Name: Feraccru® 30 mg Hartkapseln Pharmaceutical Form: Capsule, hard INN or Proposed INN: FERRIC MALTOL CAS Number: 33725-54-1 Other descriptive name: FERRIC MALTOL Concentration unit: mg millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures 2. Male and female patients =18 years at day of inclusion 3. Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial 4. Patients with a diagnosis of PH confirmed by a (historical) right heart catheterization showing a mean pulmonary artery pressure =25 mmHg at rest and stable PH medication for at least 3 months. 5. 6 min walk distance >50 m 6. Mild-to-moderate iron-deficiency anemia as defined by a hemoglobin concentration =7 g/dl and 40 IU/l and serum oestrogen =65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: 1. Active hematological disorders other than iron-deficiency anemia 2. Other medical condition that according to the investigator’s assessment is causing or contributing to anemia 3. Active malignancy 4. Active infectious disease 5. Active bleeding 6. Severe renal insufficiency (glomerular filtration rate 3 x upper limit of normal or bilirubin levels >50 µmol/l 8. Ongoing oral or intravenous iron supplementation 9. Hemoglobin 1) blood transfusions during the past 6 months

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effects of oral ferric maltol on hemoglobin levels in patients with pulmonary hypertension and anemia caused by iron deficiency ;Secondary Objective: To assess the effects of oral ferric maltol on serum ferritin, transferrin saturation, 6 min walking distance, NT-proBNP, right ventricular function (determined by echocardiography) and World Health Organization Functional Class (WHO FC) in patients with pulmonary hypertension and anemia caused by iron deficiency;Primary end point(s): • Change in hemoglobin level from baseline to week 12;Timepoint(s) of evaluation of this end point: week 12	—

Measure

Time frame

Main Objective: To assess the effects of oral ferric maltol on hemoglobin levels in patients with pulmonary hypertension and anemia caused by iron deficiency ;Secondary Objective: To assess the effects of oral ferric maltol on serum ferritin, transferrin saturation, 6 min walking distance, NT-proBNP, right ventricular function (determined by echocardiography) and World Health Organization Functional Class (WHO FC) in patients with pulmonary hypertension and anemia caused by iron deficiency;Primary end point(s): • Change in hemoglobin level from baseline to week 12;Timepoint(s) of evaluation of this end point: week 12

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Secondary

Measure	Time frame
Secondary end point(s): • Change in hemoglobin from baseline to week 6 • Change in serum ferritin levels and transferrin saturation from baseline to week 6 and 12 • Change in 6 min walking distance from baseline to week 12 • Change in serum NT-proBNP from baseline to weeks 6 and 12 • Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion) from baseline to week 12 in patients with pulmonary hypertension and anemia caused by iron deficiency. • Change in WHO FC from baseline to week 6 and week 12 ;Timepoint(s) of evaluation of this end point: week 6 week 6 and 12 week 12 week 6 and 12 week 12 week 6 and 12	—

Measure

Time frame

Secondary end point(s): • Change in hemoglobin from baseline to week 6 • Change in serum ferritin levels and transferrin saturation from baseline to week 6 and 12 • Change in 6 min walking distance from baseline to week 12 • Change in serum NT-proBNP from baseline to weeks 6 and 12 • Change in echocardiographic markers of right ventricular function (right atrial area, right ventricular diameter, fractional area change, tricuspid annular plane systolic excursion) from baseline to week 12 in patients with pulmonary hypertension and anemia caused by iron deficiency. • Change in WHO FC from baseline to week 6 and week 12 ;Timepoint(s) of evaluation of this end point: week 6 week 6 and 12 week 12 week 6 and 12 week 12 week 6 and 12

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Countries

Germany

Contacts

Public ContactProf. Marius Hoeper

Medizinische Hochschule Hannover

hoeper.marius@mh-hannover.de+49511532 3530

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026