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

Hannover Medical School1 site in 1 country22 target enrollmentMarch 27, 2018

ConditionsHypertension, Pulmonary Anemia, Iron Deficiency

InterventionsFerric maltol 30 mg (Feraccru®)

DrugsFerric maltol 30 mg (Feraccru®)

Overview

Phase: Phase 3
Intervention: Ferric maltol 30 mg (Feraccru®)
Conditions: Hypertension, Pulmonary
Sponsor: Hannover Medical School
Enrollment: 22
Locations: 1
Primary Endpoint: Change in hemoglobin level from baseline to week 12
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 27, 2018

End Date

March 19, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hannover Medical School

Responsible Party

Sponsor

Eligibility Criteria

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

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

Arms & Interventions

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

Intervention: Ferric maltol 30 mg (Feraccru®)

Outcomes

Primary Outcomes

Change in hemoglobin level from baseline to week 12

Time Frame: baseline to week 12

measurement of hemoglobin in blood

Secondary Outcomes

Change in echocardiographic markers of right ventricular function from baseline to week 12 (2)(from baseline to week 12)
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)
Change in transferrin saturation from baseline to week 6 and 12(baseline to week 6 and baseline to week 12)
Change in serum ferritin levels 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 echocardiographic markers of right ventricular function from baseline to week 12 (1)(from baseline to week 12)
Change in hemoglobin from baseline to week 6(baseline to week 6)
Change in serum NT-proBNP from baseline to weeks 6 and 12(baseline to week 6 and baseline to week 12)
Change in echocardiographic markers of right ventricular function from baseline to week 12 (3)(from baseline to week 12)
Change in echocardiographic markers of right ventricular function from baseline to week 12 (4)(from baseline to week 12)