ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1)

Sponsor

Hannover Medical School (Other)

Overall Status

Terminated

CT.gov ID

NCT03371173

Collaborator

Shields, Shields and Associates (Other)

Enrollment

Location

Arm

23.8

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an explorative, open-label, uncontrolled, single center study to explore the preliminary safety, tolerability and efficacy of oral ferric maltol in treating iron deficiency in patients with pulmonary hypertension and iron deficiency anemia.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Pulmonary Anemia, Iron Deficiency	Drug: Ferric maltol 30 mg (Feraccru®)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Explorative, open-label, uncontrolled monocenter studyExplorative, open-label, uncontrolled monocenter study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Study to Explore Preliminary Safety, Tolerability and Efficacy of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Pulmonary Hypertension and Iron Deficiency Anemia

Actual Study Start Date :

Mar 27, 2018

Actual Primary Completion Date :

Mar 19, 2020

Actual Study Completion Date :

Mar 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ferric maltol 30 mg (Feraccru®) Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily, morning and evening, on an empty stomach for 12 weeks	Drug: Ferric maltol 30 mg (Feraccru®) Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects

Arm

Intervention/Treatment

Experimental: Ferric maltol 30 mg (Feraccru®)

Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily, morning and evening, on an empty stomach for 12 weeks

Drug: Ferric maltol 30 mg (Feraccru®)

Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects

Outcome Measures

Primary Outcome Measures

Change in hemoglobin level from baseline to week 12 [baseline to week 12]
measurement of hemoglobin in blood

Secondary Outcome Measures

Change in hemoglobin from baseline to week 6 [baseline to week 6]
measurement of hemoglobin in blood
Change in serum ferritin levels from baseline to week 6 and 12 [baseline to week 6 and baseline to week 12]
measurement of serum ferritin levels
Change in transferrin saturation from baseline to week 6 and 12 [baseline to week 6 and baseline to week 12]
measurement of transferrin saturation
Change in 6 min walking distance from baseline to week 12 [baseline to week 12]
measurement of functional exercise capacity
Change in serum NT-proBNP from baseline to weeks 6 and 12 [baseline to week 6 and baseline to week 12]
measurement of serum NT-proBNP
Change in echocardiographic markers of right ventricular function from baseline to week 12 (1) [from baseline to week 12]
measurement of right atrial area
Change in echocardiographic markers of right ventricular function from baseline to week 12 (2) [from baseline to week 12]
measurement of right ventricular diameter
Change in echocardiographic markers of right ventricular function from baseline to week 12 (3) [from baseline to week 12]
measurement of fractional area change
Change in echocardiographic markers of right ventricular function from baseline to week 12 (4) [from baseline to week 12]
measurement of tricuspid annular plane systolic excursion
Change in World Health Organization Functional Class (WHO FC) from baseline to week 6 and week 12 [from baseline to week 6 and week 12]
measurement of different parameter according to an evaluated process

Other Outcome Measures

Incidence of Adverse Events [Safety and Tolerability] [first application of IMP until 4 weeks after treatment discontinuation]
Number of Adverse Events
Incidence of Serious Adverse Events [Safety and Tolerability] [first application of IMP until 4 weeks after treatment discontinuation]
Number of Serious Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
Male and female patients ≥18 years at day of inclusion
Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
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.
6 min walk distance >50 m
Mild-to-moderate iron-deficiency anemia as defined by a hemoglobin concentration ≥7 g/dl and <12 g/dl in females or ≥8 g/dl and <13 g/dl in males, and serum ferritin <100 µg/l, or 100-300 µg/l and transferrin saturation <20% at screening
Prevention of pregnancy:

Women without childbearing potential defined as follows:

at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
hysterectomy or uterine agenesis or
≥ 50 years and in postmenopausal state ≥ 1 year or
< 50 years and in postmenopausal state ≥ 1 year with serum FSH > 40 IU/l and serum oestrogen < 30 ng/l or a negative oestrogen test or

Women of childbearing potential with a negative ß-HCG pregnancy test at screening who agree to meet one of the following criteria from the time of screening, during the study and for a period of four weeks following the last administration of study medication:

correct use of contraception methods. The following are acceptable: hormonal contraceptives (combined oral contraceptives and oestrogen-free pills with desogestrel, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUS) or a barrier method, e.g. condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam, gel, film, cream or suppository)
true abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception)
sexual relationship only with female partners and/or sterile male partners

Exclusion Criteria:

Active hematological disorders other than iron-deficiency anemia
Other medical condition that according to the investigator's assessment is causing or contributing to anemia
Active malignancy
Active infectious disease
Active bleeding
Severe renal insufficiency (glomerular filtration rate <30 ml/min)
Severe liver injury as indicated by serum aminotransferases >3 x upper limit of normal or bilirubin levels >50 µmol/l
Ongoing oral or intravenous iron supplementation
Hemoglobin <7 g/dl in females or <8 g/dl in males at screening
Concomitant erythropoietin medication
Pregnancy or lactation period
Subject has received any investigational medication or any investigational device within 30 days prior to the first dose of study medication or is actively participating in any investigational drug/devices trial, or is scheduled to receive an investigational drug/device during the course of the study.
Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
Known haemochromatosis or other iron overload syndromes
Patients who have been receiving repeated (>1) blood transfusions during the past 6 months