Clinical trials: IV Iron
Chronic Kidney Disease Stage 5 (Dialysis Dependent)
A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D
The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
- Trial name
- NCT01222884
- Testing
- Monofer, Iron sucrose
- Where
- India
- Volunteers
- 351 people
- Sponsor
- Pharmacosmos A/S
Anemia
Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure
- Trial name
- NCT00548691
- Testing
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Where
- United States
- Volunteers
- 513 people
- Sponsor
- American Regent, Inc.
Iron Deficiency Anemia
Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
- Trial name
- NCT03523117
- Testing
- Ferric carboxymaltose, Ferrous Sulfate
- Where
- 16 sites in United States
- Volunteers
- 79 people
- Sponsor
- American Regent, Inc.
Iron Deficiency Anemia
Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women
The purpose of this study is to compare safety and the oxidative stress potential of two doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single dose of IV iron sucrose or IV iron dextran in…
- Trial name
- NCT01290315
- Testing
- Ferric Carboxymaltose (FCM), Iron Sucrose / Iron Dextran
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- American Regent, Inc.
Iron Deficiency Anemia (IDA)
Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron
The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs.
- Trial name
- NCT01950247
- Testing
- Injectafer, SOC
- Volunteers
- 1,025 people
- Sponsor
- American Regent, Inc.
Iron Overload
Safety Study of Crushed Deferasirox Film Coated Tablets in Pediatric Patients With Transfusional Hemosiderosis
This study employed a prospective, single-arm, global multi-center interventional open-label, non-randomized design to identify and assess safety profile of the crushed deferasirox FCT when administered up to 24 weeks in…
- Trial name
- MIMAS (NCT03372083)
- Testing
- Deferasirox
- Where
- 10 sites in Egypt, Italy and 5 more
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Anemia
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.
- Trial name
- NCT00548860
- Testing
- Ferric Carboxymaltose, Standard Medical Care (SMC)
- Where
- United States
- Volunteers
- 2,018 people
- Sponsor
- American Regent, Inc.
Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass
The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric Bypass patients may demonstrate to be…
- Trial name
- NCT02086968
- Testing
- Injectafer, Ferrous Sulfate tablets
- Volunteers
- 198 people
- Sponsor
- American Regent, Inc.
Anemia, Non-Myeloid Malignancies
Darbepoetin Alfa With or Without Intravenous (IV) Iron
To deterime the efficacy of 500 μg and 300 μg darbepoetin alfa administered subcutaneously (SC) on an every 3 weeks (Q3W) schedule, and the effect of intravenous (IV) iron supplementation in the treatment of anemia in patients…
- Trial name
- NCT00401544
- Testing
- darbepoetin alfa, IV iron dextran
- Volunteers
- 243 people
- Sponsor
- Amgen
Anemia
Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.
- Trial name
- NCT00236951
- Testing
- iron sucrose injection USP, stable erythropoietin therapy
- Volunteers
- 224 people
- Sponsor
- American Regent, Inc.
Restless Legs
Intravenous Iron Metabolism in Restless Legs Syndrome
Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome
- Trial name
- RLS (NCT00685815)
- Testing
- Ferric Carboxymaltose (FCM)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- American Regent, Inc.
Iron Deficiency Anemia Treatment, Chronic Kidney Disease(CKD)
Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis
The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.
- Trial name
- NCT01227616
- Testing
- Ferumoxytol, Iron Sucrose
- Where
- 43 sites in United States, Canada and 1 more
- Volunteers
- 296 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Iron Deficiency Anemia (IDA)
A Study to Characterize the PK and PD Profile of IV FCM in Pediatric Subjects 1-17 Years Old With IDA
This is a Phase II, open-label, non-randomized, multi-center, single arm study to characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric Carboxymaltose dosing in pediatric subjects with IDA after…
- Trial name
- NCT02410213
- Testing
- Ferric Carboxymaltose (FCM)
- Where
- 10 sites in Poland, Russia
- Volunteers
- 35 people
- Sponsor
- American Regent, Inc.
Restless Legs Syndrome (RLS)
Intravenous (IV) Iron Preparation (VIT-45) in the Treatment of Restless Legs Syndrome (RLS)
The purpose of this study was to evaluate the safety of 2 dosage regimens of Intravenous (IV) iron Ferric Carboxymaltose (FCM) in comparison to placebo in patients with Restless Legs Syndrome (RLS)
- Trial name
- NCT01382901
- Testing
- Ferric Carboxymaltose (FCM)
- Volunteers
- 45 people
- Sponsor
- American Regent, Inc.
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