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

Hypertension, Pulmonary Clinical Trial

— ORION-PH-1  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03371173
• Other study ID #: ORION-PH-1
• Status: Terminated
• Phase: Phase 3
• Start date: March 27, 2018
• Est. completion date: March 19, 2020

Study information

• Verified date: June 2019
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: March 19, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 <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

7. 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:

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 <30 ml/min)

7. Severe liver injury as indicated by serum aminotransferases >3 x upper limit of normal or bilirubin levels >50 µmol/l

8. Ongoing oral or intravenous iron supplementation

9. Hemoglobin <7 g/dl in females or <8 g/dl in males at screening

10. Concomitant erythropoietin medication

11. Pregnancy or lactation period

12. 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.

13. Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product

14. Known haemochromatosis or other iron overload syndromes

15. Patients who have been receiving repeated (>1) blood transfusions during the past 6 months

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Hypertension
• Hypertension, Pulmonary

Intervention

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

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Shields, Shields and Associates

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Adverse Events [Safety and Tolerability]	Number of Adverse Events	first application of IMP until 4 weeks after treatment discontinuation
Other	Incidence of Serious Adverse Events [Safety and Tolerability]	Number of Serious Adverse Events	first application of IMP until 4 weeks after treatment discontinuation
Primary	Change in hemoglobin level from baseline to week 12	measurement of hemoglobin in blood	baseline to week 12
Secondary	Change in hemoglobin from baseline to week 6	measurement of hemoglobin in blood	baseline to week 6
Secondary	Change in serum ferritin levels from baseline to week 6 and 12	measurement of serum ferritin levels	baseline to week 6 and baseline to week 12
Secondary	Change in transferrin saturation from baseline to week 6 and 12	measurement of transferrin saturation	baseline to week 6 and baseline to week 12
Secondary	Change in 6 min walking distance from baseline to week 12	measurement of functional exercise capacity	baseline to week 12
Secondary	Change in serum NT-proBNP from baseline to weeks 6 and 12	measurement of serum NT-proBNP	baseline to week 6 and baseline to week 12
Secondary	Change in echocardiographic markers of right ventricular function from baseline to week 12 (1)	measurement of right atrial area	from baseline to week 12
Secondary	Change in echocardiographic markers of right ventricular function from baseline to week 12 (2)	measurement of right ventricular diameter	from baseline to week 12
Secondary	Change in echocardiographic markers of right ventricular function from baseline to week 12 (3)	measurement of fractional area change	from baseline to week 12
Secondary	Change in echocardiographic markers of right ventricular function from baseline to week 12 (4)	measurement of tricuspid annular plane systolic excursion	from baseline to week 12
Secondary	Change in World Health Organization Functional Class (WHO FC) from baseline to week 6 and week 12	measurement of different parameter according to an evaluated process	from baseline to week 6 and week 12