Clinical trials: Iron Deficiency Anaemia
Iron Deficiency, Anaemia in Children
Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia
Several clinical trials have been reported for ferric derisomaltose where it has been shown to be well tolerated and to improve markers of IDA.
- Trial name
- NCT05179226
- Testing
- Ferric Derisomaltose
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Pharmacosmos A/S
Iron Deficiency Anaemia
Safety and Efficacy Study of Ferric Maltol To Treat Iron Deficiency Anaemia in Chinese Patients With Inflammatory Bowel Disease
The purpose of this study is to determine whether Ferric Maltol, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with inflammatory bowel disease (IBD).
- Trial name
- NCT07739368
- Testing
- Ferric Maltol
- Where
- China
- Volunteers
- 122 people
- Sponsor
- Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Iron Deficiency, Anaemia
Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia
The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in participants with iron deficiency anaemia under fasting condition.
- Trial name
- NCT06080555
- Testing
- Ferric Carboxymaltose Injection, Ferric Carboxymaltose Injection [Ferinject]
- Where
- 4 sites in China
- Volunteers
- 84 people
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Iron Deficiency, Anaemia
Safety, Tolerability, PK and PD of Intravenous Ferric Carboxymaltose in Infants With Iron Deficiency Anemia
An Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous Ferric Carboxymaltose (FCM) in Infants (0-1 year) with Iron Deficiency Anemia.
- Trial name
- NCT04968379
- Testing
- Ferric carboxymaltose
- Where
- 4 sites in United States
- Sponsor
- American Regent, Inc.
Chronic Heart Failure, Iron Deficiency
Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF)
This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures.
- Conditions
- Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia, Anaemia
- Trial name
- FAIR-HF (NCT00520780)
- Testing
- Ferinject ® (Ferric carboxymaltose), Normal saline (0.9%)
- Where
- 48 sites in Argentina, Germany and 8 more
- Volunteers
- 456 people
- Sponsor
- Vifor Pharma
Iron Deficiency, Anaemia in Children, Iron-Deficiency
Evaluate the PK, Safety, Tolerability of Ferric Maltol at 3 Dosage Levels in Paediatric Subjects With Iron Deficiency
The study has been designed to establish the pharmacokinetics (PK) and iron uptake of Ferric Maltol in children and adolescents aged 10-17 years using two (2) lower dose strengths in comparison to the EU-approved 30mg BID dose in…
- Trial name
- NCT03181451
- Testing
- Ferric Maltol
- Where
- 7 sites in United Kingdom
- Volunteers
- 37 people
- Sponsor
- Shield Therapeutics
Mild and Moderate Iron-deficiency Anaemia
Study to Test the Hypothesis of Non-inferior Efficacy and Safety of Ferrum Lek® (Iron (III) Hydroxide Polymaltosate), 100 mg Chewable Tablets (Lek d.d., Slovenia), as Compared With MALTOFER® (Vifor S.A., Switzerland), in Subjects With Mild and Moderate Iron Deficiency Anemia.
The purpose of this study was to evaluate non-inferiority for efficacy and safety of Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia), compared to MALTOFER® (Vifor S.A., Switzerland)…
- Trial name
- NCT03993288
- Testing
- Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia), MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland)
- Where
- 18 sites in Russia
- Volunteers
- 267 people
- Sponsor
- Sandoz
Iron Deficiency Anaemia, Inflammatory Bowel Disease
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1)
The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active ulcerative colitis (UC).
- Conditions
- Iron Deficiency Anaemia, Inflammatory Bowel Disease, Ulcerative Colitis
- Trial name
- AEGIS-1 (NCT01340872)
- Testing
- ST10-021
- Volunteers
- 128 people
- Sponsor
- Shield Therapeutics
Iron Deficiency Anaemia, Inflammatory Bowel Disease
Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Crohn's Disease (AEGIS-2)
The purpose of this study is to determine whether ST10-021, an oral ferric iron preparation, is safe and effective in the treatment of iron deficiency anaemia (IDA) in subjects with non-active Crohn's Disease (CD).
- Conditions
- Iron Deficiency Anaemia, Inflammatory Bowel Disease, Crohn's Disease
- Trial name
- AEGIS-2 (NCT01352221)
- Testing
- ST10
- Volunteers
- 128 people
- Sponsor
- Shield Therapeutics
Iron Deficiency Anaemia, Iron Deficiency Anemia
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease
Evaluation of safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose, in subjects with both non-dialysis-dependent chronic kidney disease (NDD-CKD) and iron deficiency anaemia (IDA).
- Conditions
- Iron Deficiency Anaemia, Iron Deficiency Anemia, Chronic Kidney Disease
- Trial name
- NCT02940860
- Testing
- Iron isomaltoside/ferric derisomaltose, Iron sucrose
- Where
- 141 sites in United States
- Volunteers
- 1,538 people
- Sponsor
- Pharmacosmos A/S
Iron Deficiency Anaemia, Iron Deficiency Anemia
Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)
Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.
- Trial name
- NCT02940886
- Testing
- Iron isomaltoside/ferric derisomaltose, Iron sucrose
- Where
- 114 sites in United States
- Volunteers
- 1,512 people
- Sponsor
- Pharmacosmos A/S
Iron Deficiency Anemia, Iron Deficiency Anaemia
An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside/Ferric Derisomaltose (Monofer®/Monoferric®)
Evaluate safety and efficacy of intravenous (IV) iron isomaltoside/ferric derisomaltose re-dosing, in subjects who were previously treated with iron isomaltoside/ferric derisomaltose.
- Trial name
- FERWON-EXT (NCT02962648)
- Testing
- Iron isomaltoside/ferric derisomaltose
- Where
- 22 sites in United States
- Volunteers
- 103 people
- Sponsor
- Pharmacosmos A/S
Iron Deficiency Anaemia, Iron Deficiency Anemia
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).
- Trial name
- NCT03237065
- Testing
- Iron isomaltoside/ferric derisomaltose, Ferric carboxymaltose
- Where
- 15 sites in United States
- Volunteers
- 122 people
- Sponsor
- Pharmacosmos A/S
Iron Deficiency Anaemia, Iron Deficiency Anemia
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of phosphate in the blood) in subjects with iron deficiency anaemia (IDA).
- Trial name
- NCT03238911
- Testing
- Iron isomaltoside/ferric derisomaltose, Ferric carboxymaltose
- Where
- 16 sites in United States
- Volunteers
- 123 people
- Sponsor
- Pharmacosmos A/S
Iron Deficiency Anaemia
Time to Relapse of Iron Deficiency Anaemia After Standard Treatment With The Intravenous Iron (Monofer®)
The objective is to monitor and quality assure the efficacy, including effects on quality of life, and safety of Monofer® in Chronic Kidney Disease and Inflammatory Bowel Disease patient populations when Monofer® is used…
- Trial name
- NCT02546154
- Testing
- 10% Iron Isomaltoside 1000
- Where
- United Kingdom
- Volunteers
- 359 people
- Sponsor
- Pharmacosmos UK Ltd
Iron Deficiency Anaemia
IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose
The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be…
- Trial name
- Provide (NCT02130063)
- Testing
- iron isomaltoside 1000 (Monofer®), iron sucrose (Venofer®)
- Where
- United States
- Volunteers
- 511 people
- Sponsor
- Pharmacosmos A/S
Chronic Heart Failure, Iron Deficiency
EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac Function in Patients With Iron deficiencY and Chronic Heart Failure
This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxymaltose) to the basic regimen of ambulatory…
- Conditions
- Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia, Anaemia
- Trial name
- EFFICACY-HF (NCT00821717)
- Testing
- Ferinject ® (Ferric carboxymaltose), Normal saline (0.9%)
- Where
- 41 sites in Denmark, France and 3 more
- Volunteers
- 35 people
- Sponsor
- Vifor Pharma
Anaemia
Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) Versus Oral Iron for Iron Deficiency Anaemia in Pregnant Women
The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the…
- Trial name
- ASAP (NCT01131624)
- Testing
- ferrous sulphate, Ferinject
- Where
- 20 sites in Australia, Germany and 3 more
- Volunteers
- 252 people
- Sponsor
- Vifor Pharma
Iron Deficiency Anaemia, Chronic Kidney Disease
Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron…
- Trial name
- FIND-CKD (NCT00994318)
- Testing
- FCM (Ferric carboxymaltose) high ferritin target, FCM (Ferric carboxymaltose) low ferritin target, Oral Iron (Ferrous sulphate)
- Where
- 19 sites in United States, Australia and 17 more
- Volunteers
- 626 people
- Sponsor
- Vifor Pharma