Hypertension, PulmonaryPhase 3ORION-PH-1NCT03371173
ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1)
A Phase 3 study testing Ferric maltol 30 mg (Feraccru®) in people with Hypertension, Pulmonary and Anemia, Iron Deficiency, run by Hannover Medical School at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary, Anemia, Iron Deficiency
- What is being tested?
- Ferric maltol 30 mg (Feraccru®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteGermany
- Study dates
- 27 Mar 2018to 19 Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Ferric maltol 30 mg (Feraccru®)
- Keywords
- Pulmonary Hypertension, Iron Deficiency
- Medical subject headings
- Hypertension, Pulmonary, Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Ferric maltol 30 mg (Feraccru®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin level from baseline to week 12
measurement of hemoglobin in blood
Measured: baseline to week 12
Secondary outcomes (10)
Change in hemoglobin from baseline to week 6
measurement of hemoglobin in blood
Measured: baseline to week 6
Change in serum ferritin levels from baseline to week 6 and 12
measurement of serum ferritin levels
Measured: baseline to week 6 and baseline to week 12
Change in transferrin saturation from baseline to week 6 and 12
measurement of transferrin saturation
Measured: baseline to week 6 and baseline to week 12
Change in 6 min walking distance from baseline to week 12
measurement of functional exercise capacity
Measured: baseline to week 12
Change in serum NT-proBNP from baseline to weeks 6 and 12
measurement of serum NT-proBNP
Measured: baseline to week 6 and baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (1)
measurement of right atrial area
Measured: from baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (2)
measurement of right ventricular diameter
Measured: from baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (3)
measurement of fractional area change
Measured: from baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (4)
measurement of tricuspid annular plane systolic excursion
Measured: from baseline to week 12
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
Measured: from baseline to week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start27 Mar 2018
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Why it stopped: low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Explorative, open-label, uncontrolled monocenter study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Shields, Shields and Associates
- Responsible party
- Sponsor
- Investigators
- Marius Hoeper, Prof. Dr., Principal investigator, Hannover Medical School, Department of Pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371173
- Sponsor's protocol ID
- ORION-PH-1
- Acronym
- ORION-PH-1
- Status last verified
- Jun 2019
- First submitted
- 16 Oct 2017
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32444411
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03371173
- Acronym / sponsor ID
- ORION-PH-1 / ORION-PH-1
- Conditions
- Hypertension, Pulmonary, Anemia, Iron Deficiency
- Keywords
- Pulmonary Hypertension, Iron Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Shields, Shields and Associates
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Explorative, open-label, uncontrolled monocenter study
| Arm | Type | Receives |
|---|---|---|
| Ferric maltol 30 mg (Feraccru®) | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Ferric maltol 30 mg (Feraccru®) |
Primary outcome
Change in hemoglobin level from baseline to week 12
Time frame: baseline to week 12
measurement of hemoglobin in blood
10 secondary outcomes
Change in hemoglobin from baseline to week 6
Time frame: baseline to week 6
Change in serum ferritin levels from baseline to week 6 and 12
Time frame: baseline to week 6 and baseline to week 12
Change in transferrin saturation from baseline to week 6 and 12
Time frame: baseline to week 6 and baseline to week 12
Change in 6 min walking distance from baseline to week 12
Time frame: baseline to week 12
Change in serum NT-proBNP from baseline to weeks 6 and 12
Time frame: baseline to week 6 and baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (1)
Time frame: from baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (2)
Time frame: from baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (3)
Time frame: from baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (4)
Time frame: from baseline to week 12
Change in World Health Organization Functional Class (WHO FC) from baseline to week 6 and week 12
Time frame: from baseline to week 6 and week 12
Results and safety
The study was stopped early (reason given: low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Derived from this study: PubMed 32444411Olsson 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.
Related trials for Hypertension, Pulmonary
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marius Hoeper, Prof. Dr. principal investigator
Hannover Medical School, Department of Pneumology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric maltol 30 mg (Feraccru®) in people with Hypertension, Pulmonary and Anemia, Iron Deficiency, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: low recruitment rate; difficulties to achieve planned number of participants within reasonable time frame). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin level from baseline to week 12 (time frame: baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03371173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.