Clinical trials: Iron
Myelodysplastic Syndrome, Transfusional Iron Overload
Myelodysplastic Syndrome (MDS) Gastrointestinal (GI) Tolerability Study
The objective of the study is to evaluate and compare the frequency and severity of GI adverse events in different dose administration regimens.
- Trial name
- MACS1574 (NCT01326845)
- Testing
- Deferasirox
- Where
- 10 sites in France, Italy and 2 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Anemia of Chronic Kidney Disease
A Study to Investigate the Effect of Roxadustat Versus Recombinant Human Erythropoietin (rHuEPO) on Oral Iron Absorption in Chinese Patients With Anemia of Chronic Kidney Disease (CKD)
This is a Phase IV, randomized, active-controlled, open-label, parallel design, multicenter prospective study to evaluate the effect of roxadustat versus rHuEPO treatment on the gastrointestinal (GI) iron absorption in patients…
- Trial name
- NCT04655027
- Testing
- Roxadustat, rHuEPO
- Where
- 8 sites in China
- Volunteers
- 25 people
- Sponsor
- AstraZeneca
Advanced Solid Tumor, Lung Cancer
Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in the Treatment of Advanced Solid Tumor
This Phase I clinical trial aims to evaluate the safety, tolerability, pharmacokinetics (PK) profile and preliminary efficacy of intratumoral injection of Carbon Nanoparticle-Loaded Iron [CNSI-Fe(II)] in patients with advanced…
- Conditions
- Advanced Solid Tumor, Lung Cancer, Pancreas Cancer, Breast Cancer
- Trial name
- CNSI-Fe(II) (NCT06048367)
- Testing
- CNSI-Fe(II) 30 mg, CNSI-Fe(II) 60 mg, CNSI-Fe(II) 90 mg
- Where
- China
- Volunteers
- 19 people
- Sponsor
- Sichuan Enray Pharmaceutical Sciences Company
Chronic Iron Overload
Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation
Extend evaluation of deferasirox film-coated tablet (FCT) formulation
- Trial name
- NCT02720536
- Testing
- Deferasirox
- Where
- 14 sites in Austria, Greece and 1 more
- Volunteers
- 53 people
- Sponsor
- Novartis Pharmaceuticals
Heart Transplant Recipients
Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients
Iron deficiency is prevalent in heart transplant recipients, and may be associated with reduced functional capacity. The IronIC trial is designed to assess the effect of intravenous iron isomaltoside on exercise capacity, muscle…
- Trial name
- IronIC (NCT03662789)
- Testing
- Iron Isomaltoside 1000
- Where
- Norway
- Volunteers
- 102 people
- Sponsor
- Oslo University Hospital
Steroid-refractory Diamond-Blackfan Anemia (DBA)
Study of the Selective GlyT1 Inhibitor Bitopertin for Steroid-Refractory Diamond-Blackfan Anemia
Background: Diamond-Blackfan anemia (DBA) is an inherited disease that affects the bone marrow. People with DBA have chronic anemia that can be severe. Many must have frequent transfusions of red blood cells.
- Trial name
- NCT05828108
- Testing
- Bitopertin
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Iron Overload, Sickle Cell Disease
Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients With Sickle Cell Disease or Other Anemias
This is a long-term follow-up to an earlier study, LA38-0411. Its purpose is to gather more information about the safety and efficacy of deferiprone in patients with sickle cell disease or other anemias who suffer from iron…
- Conditions
- Iron Overload, Sickle Cell Disease, Other Anemias
- Trial name
- NCT02443545
- Testing
- Deferiprone
- Where
- 13 sites in United States, Canada and 3 more
- Volunteers
- 134 people
- Sponsor
- ApoPharma
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
Anemia, Pregnancy Complications
Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment
The purpose of this study is to compare the efficacy of body iron storage replenishment between low dose intravenous iron and oral iron in late pregnancy.
- Trial name
- EIVF (NCT00746551)
- Testing
- Ferli-6® (Continental Pharm co., ltd.), Venofer® (Vifor AG, St. Gallen, Switzerland)
- Where
- Thailand
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Liver Iron Overload
Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study
The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.
- Trial name
- NCT01033747
- Testing
- Deferasirox
- Where
- 4 sites in Italy
- Volunteers
- 70 people
- Sponsor
- Novartis Pharmaceuticals
Anemia, Renal Failure
Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure
The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.
- Trial name
- NCT00318812
- Testing
- Heme Iron Polypeptide (Proferrin), Iron sucrose (Venofer)
- Where
- Canada
- Volunteers
- 55 people
- Sponsor
- Ottawa Hospital Research Institute
Iron, Abnormal Blood Level, Other Abnormal Blood Chemistry
Fresh Versus Old Red Blood Cells for Transfusion
Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on Food and Drug Administration (FDA) guidelines.
- Trial name
- NCT01319552
- Testing
- Fresh transfusion, Old transfusion
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Columbia University
Healthy
Effects of Iron Supplements on the Pharmacokinetics of MT-6548
The objectives of this study are to investigate the pharmacokinetics and safety of MT-6548 co-administered with iron supplements in healthy male volunteers.
- Trial name
- NCT03645863
- Testing
- MT-6548, Iron supplement A, Iron supplement B
- Where
- Japan
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Iron Overload After Hematopoietic Stem Cell Transplantation (HSCT) in Patients With Beta-thalassemia Major
Post Hematopoietic Stem Cell Transplantation
This was a prospective, single-arm, multicenter, national, phase II clinical study. The purpose of this Phase II study was to examine the safety and efficacy of deferasirox to decrease iron overload (IOL) in the posttransplant…
- Trial name
- NCT01610297
- Testing
- ICL670
- Where
- 6 sites in Turkey (Türkiye)
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
Transfusion-dependent Anemia
Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload
This was a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment compliance and change in serum ferritin of a deferasirox granule formulation and a deferasirox dispersible tablet (DT) formulation in…
- Trial name
- NCT02435212
- Testing
- Deferasirox granule formulation, Deferasirox DT formulation
- Where
- 43 sites in United States, Belgium and 15 more
- Volunteers
- 224 people
- Sponsor
- Novartis Pharmaceuticals
Restless Legs Syndrome (RLS)
Randomized, Placebo-controlled Trial of Ferric Carboxymaltose in RLS Patients With Iron-deficiency Anemia
Treatment Phase I and II Primary Objective: To evaluate the efficacy and safety of FCM (750 mg dose x 2) for treatment of Restless Legs Syndrome (RLS) in patients with iron-deficiency anemia (IDA).
- Trial name
- NCT02826681
- Testing
- Injectafer® (Ferric Carboxymaltose - FCM)
- Where
- 8 sites in United States
- Volunteers
- 70 people
- Sponsor
- American Regent, Inc.
Renal Insufficiency, Chronic, Iron-Deficiency Anemia
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD
- Trial name
- AEGIS-CKD (NCT02968368)
- Testing
- Ferric maltol
- Where
- 27 sites in United States
- Volunteers
- 167 people
- Sponsor
- Shield Therapeutics