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

NCT03371173 | Terminated Phase 3

• 1 other identifier: ORION-PH-1
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension, Pulmonary; Anemia, Iron Deficiency

Keywords

Pulmonary Hypertension; Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin level from baseline to week 12

  measurement of hemoglobin in blood

  baseline to week 12

Secondary Outcomes (10)

• Change in hemoglobin from baseline to week 6

  baseline to week 6

• Change in serum ferritin levels from baseline to week 6 and 12

  baseline to week 6 and baseline to week 12

• Change in transferrin saturation from baseline to week 6 and 12

  baseline to week 6 and baseline to week 12

• Change in 6 min walking distance from baseline to week 12

  baseline to week 12

• Change in serum NT-proBNP from baseline to weeks 6 and 12

  baseline to week 6 and baseline to week 12

Other Outcomes (2)

• Incidence of Adverse Events [Safety and Tolerability]

  first application of IMP until 4 weeks after treatment discontinuation

• Incidence of Serious Adverse Events [Safety and Tolerability]

  first application of IMP until 4 weeks after treatment discontinuation

Study Arms (1)

Ferric maltol 30 mg (Feraccru®)

EXPERIMENTAL

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®)

Interventions

Ferric maltol 30 mg (Feraccru®) DRUG

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

Ferric maltol 30 mg (Feraccru®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• Shields, Shields and Associates: collaborator

Study Sites (1)

Hannover Medical School

Hanover, 30625, Germany

Location

Related Publications (1)

• Olsson KM, Fuge J, Brod T, Kamp JC, Schmitto J, Kempf T, Bauersachs J, Hoeper MM. Oral iron supplementation with ferric maltol in patients with pulmonary hypertension. Eur Respir J. 2020 Nov 12;56(5):2000616. doi: 10.1183/13993003.00616-2020. Print 2020 Nov.

  PMID: 32444411 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary; Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

ferric maltol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Marius Hoeper, Prof. Dr.

  Hannover Medical School, Department of Pneumology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Explorative, open-label, uncontrolled monocenter study

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: December 13, 2017
• Study Start: March 27, 2018
• Primary Completion: March 19, 2020
• Study Completion: March 19, 2020
• Last Updated: April 21, 2020

Record last verified: 2019-06

Locations

DE (1)