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
Iron Deficiency Anemia (IDA)
Observational Study on the Use of IV (Intravenous) Iron Therapy Among Subjects With Iron Deficiency Anemia
The primary objective of this study is to compare the total costs to sites and payers of administering IV iron over the 30-day observation period for subjects with IDA who receive Ferric Carboxymaltose (FCM) relative to those who…
- Trial name
- NCT01984554
- Where
- United States
- Volunteers
- 551 people
- Sponsor
- American Regent, Inc.
Non-dialysis Dependent Chronic Kidney Disease
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous to Patients With CKD
The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer® in patients suffering from Non-dialysis Dependent Chronic Kidney Disease.
- Trial name
- PK-CKD-03 (NCT01213992)
- Testing
- Iron isomaltoside 1000
- Volunteers
- 16 people
- Sponsor
- Pharmacosmos A/S
Patients With Chemotherapy Induced Anemia (CIA)
Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 250 mg and 500 mg in patients suffering from Chemotherapy Induced anemia.
- Trial name
- PK-CIA-06 (NCT01280240)
- Testing
- Monofer(R)
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Pharmacosmos A/S
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.
Anemia
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
The purpose of the study was to compare the efficacy of oral iron (ferrous sulfate) plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis.
- Trial name
- NCT00236964
- Testing
- Iron Sucrose + Erythropoietin, Oral Iron + Erythropoietin
- Volunteers
- 96 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.
Iron Deficiency Anemia (IDA)
A Study to Test the Non-Inferiority of Ferric Bepectate IV Against Ferric Carboxymaltose in Patients With Iron Deficiency Anemia
The goal of this clinical trial is to see if a new intravenous iron formulation (Ferric Bepectate IV Injection) can treat adult patients with iron deficiency anemia (IDA) by increasing blood hemoglobin (Hb) as an established…
- Trial name
- NCT07687784
- Testing
- Ferric Bepectate IV Injection, Ferric Carboxymaltose Injection [Ferinject], Ferric Carboxymaltose Injection [Injectafer®]
- Where
- 13 sites in United States, Bulgaria and 2 more
- Volunteers
- 1,366 people
- Sponsor
- AFT Pharmaceuticals, Ltd.
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, Iron-Deficiency, Kidney Failure, Chronic
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
This study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation.
- Conditions
- Anemia, Iron-Deficiency, Kidney Failure, Chronic, Hemodialysis
- Trial name
- DRIVE (NCT00224081)
- Testing
- Sodium ferric gluconate,
- Where
- 29 sites in United States
- Volunteers
- 134 people
- Sponsor
- Watson Pharmaceuticals
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 Syndrome
IV Iron Treatment of Restless Legs Syndrome
The purpose of this study is to to establish proof-of-concept for efficacy of iron isomaltoside 1000 in subjects with Restless Legs Syndrome. The study is a randomised, comparative, double-blind study with a 3 months extension.
- Trial name
- NCT02484768
- Testing
- Iron isomaltoside 1000, Sodium Chloride 0.9%
- Sponsor
- Pharmacosmos A/S
Inflammatory Bowel Disease
Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease
The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease
- Trial name
- NCT01213680
- Testing
- Monofer (iron isomaltoside 1000), Monofer
- Volunteers
- 16 people
- Sponsor
- Pharmacosmos A/S
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.