A Phase 3 interventional study of Ferric maltol 30 mg (Feraccru®) in Hypertension, Pulmonary and Anemia, Iron Deficiency, sponsored by Hannover Medical School. Terminated at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by Hannover Medical School · Phase 3, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 150 studies in Hypertension, Pulmonary with a site in Germany — 21 open to participants now, 28 under way, 6 of them phase 3. Hypertension, Pulmonary · Germany.
Among the 150 studies in Hypertension, Pulmonary with a site in Germany, this one is the 91st largest by enrollment of the 105 interventional ones that give a count, is one of 9 that started in 2018, is one of 37 in phase 3, and was the 96th registered.
1,091 studies on the registry are indexed under Hypertension, Pulmonary; 243 are open to participants now.
Browse Hypertension, Pulmonary studies →21 of the 150 studies in Hypertension, Pulmonary with a site in Germany are open now. Recruiting first, the newest first:
Insmed Incorporated · Sites in Germany, United States, Czechia and 5 more countries
Ages 18+
Regeneron Pharmaceuticals · Sites in Germany, United States, Australia and 7 more countries
Ages 18+
Liquidia Technologies, Inc. · Sites in Germany, United States, Australia and 9 more countries
Ages 18–80
Insmed Incorporated · Sites in Germany, United States, Argentina and 27 more countries
Ages 18+
AllRock Bio, Inc. · Sites in Germany, United States, Australia and 6 more countries
Ages 18–80
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 163 Hypertension, Pulmonary studies recruiting now, 99 (61%) set no upper age limit and 26 (16%) stop at 75 or younger; 39 take children under 18; 24 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
150 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 40 · Phase 3 39 · Phase 4 2
First in 1993; this study’s year is marked. 9 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Median enrollment 86 across the 105 interventional studies, 394 across the 44 observational. Of the 105 that completed or were terminated, 47 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
86 of 150 have an industry lead sponsor. The 10 most frequent:
Hannover Medical School is the lead sponsor of 202 studies on the registry; 25 are open to participants now.
Hannover Medical School has 4 studies filed under Hypertension, Pulmonary — fewer than ten, so there is no comparison to draw.
6 of the studies in Hypertension, Pulmonary with a site in Germany that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03683186Phase 3United TherapeuticsA Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension | 2026-12 |
| NCT06616974Tectonic TherapeuticA Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study) | 2026-11-24 |
| NCT05903001RWTH Aachen UniversityDiaphragmatic Function as a Biomarker | 2026-12-30 |
| NCT01347216Technische Universität DresdenCOMPERA / COMPERA-KIDS | 2026-12-31 |
| NCT07175038AllRock Bio, Inc.A Study of ROC-101 in Patients With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (ILD-PH) (ROCSTAR STUDY) | 2027-03 |
Add all 6 to your calendar (.ics) → With an account.
Among the 150 studies in Hypertension, Pulmonary with a site in Germany, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Women without defined as follows:
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Change in hemoglobin level from baseline to week 12
measurement of hemoglobin in blood
Time frame: baseline to week 12
Change in hemoglobin from baseline to week 6
measurement of hemoglobin in blood
Time frame: baseline to week 6
Change in serum ferritin levels from baseline to week 6 and 12
measurement of serum ferritin levels
Time frame: baseline to week 6 and baseline to week 12
Change in transferrin saturation from baseline to week 6 and 12
measurement of transferrin saturation
Time frame: 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
Time frame: baseline to week 12
Change in serum NT-proBNP from baseline to weeks 6 and 12
measurement of serum NT-proBNP
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)
measurement of right atrial area
Time frame: from baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (2)
measurement of right ventricular diameter
Time frame: from baseline to week 12
Change in echocardiographic markers of right ventricular function from baseline to week 12 (3)
measurement of fractional area change
Time frame: 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
Time frame: 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
Time frame: from baseline to week 6 and week 12
Incidence of Adverse Events [Safety and Tolerability]
Number of Adverse Events
Time frame: first application of IMP until 4 weeks after treatment discontinuation
Incidence of Serious Adverse Events [Safety and Tolerability]
Number of Serious Adverse Events
Time frame: first application of IMP until 4 weeks after treatment discontinuation
Ran from Mar 2018 to primary completion in Mar 2020, 23 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ferric maltol