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A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

2014-08-27 03:14:04 | BioPortfolio

Summary

To evaluate the efficacy and safety of IV ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Iron Deficiency Anemia

Intervention

Ferumoxytol, Placebo

Location

AMAG Pharmaceuticals, Inc.
Lexington
Massachusetts
United States
02421

Status

Recruiting

Source

AMAG Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:04-0400

Clinical Trials [1372 Associated Clinical Trials listed on BioPortfolio]

A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia

The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).

Ferumoxytol for Iron-Deficiency Anemia in Chronic Kidney Disease and Peritoneal Dialysis Patients

The purpose of this study is to investigate the efficacy of ferumoxytol for the repletion of iron stores and correction of iron deficiency anaemia in patients with severe chronic kidney di...

Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA).

Iron Indices and Intravenous Ferumoxytol: Time to Steady State - a Pilot Study

The purpose of this study is to evaluate the time point of TSAT and ferritin stabilization after a thirteen-treatment period following a Feraheme™ load, as well as to determine the poin...

A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

To evaluate the safety of 1.020 g of IV ferumoxytol compared to 1.500 g of IV Ferric Carboxymaltose (FCM).

PubMed Articles [4390 Associated PubMed Articles listed on BioPortfolio]

Characterization of the population with severe iron deficiency anemia at risk of requiring intravenous iron supplementation.

Iron deficiency anemia is the most frequent cause of anemia world-wide and is a very common disorder in daily medical practice. Heavy menstrual bleeding (menorrhagia) and pregnancy and delivery can ca...

Prevalence and pROgnostic impact of anemia and IRON deficiency in patients hospitalized in an internal medicine ward: the PRO-IRON Study.

To assess prevalence, predictive factors, and prognostic impact on in-hospital mortality of anemia, iron deficiency anemia (IDA), iron deficiency with or without anemia (ID), and iron deficiency witho...

Iron deficiency was not the major cause of anemia in rural women of reproductive age in Sidama zone, southern Ethiopia: A cross-sectional study.

Anemia, which has many etiologies, is a moderate/severe public health problem in young children and women of reproductive age in many developing countries. The aim of this study was to investigate pre...

Malaria exacerbates inflammation-associated elevation in ferritin and soluble transferrin receptor with only modest effects on iron deficiency and iron deficiency anemia among rural Zambian children.

In 4-8-year-old Zambian children (n=744), we evaluated the effects of adjusting for inflammation (α1-acid glycoprotein > 1 g/L), with or without additional adjustment for malaria, on prevalence estim...

SAFETY AND EFFICACY OF INTRAVENOUS ADMINISTRATION OF IRON PREPARATIONS.

Iron deficiency is the main cause of anemia worldwide. Iron supplementation leads to a rise of transferrin saturation and ferritin concentration, resulting in an increased hemoglobin level and decreas...

Medical and Biotech [MESH] Definitions

Anemia characterized by decreased or absent iron stores, low serum iron concentration, low transferrin saturation, and low hemoglobin concentration or hematocrit value. The erythrocytes are hypochromic and microcytic and the iron binding capacity is increased.

Iron or iron compounds used in foods or as food. Dietary iron is important in oxygen transport and the synthesis of the iron-porphyrin proteins hemoglobin, myoglobin, cytochromes, and cytochrome oxidase. Insufficient amounts of dietary iron can lead to iron-deficiency anemia.

Anemia characterized by a decrease in the ratio of the weight of hemoglobin to the volume of the erythrocyte, i.e., the mean corpuscular hemoglobin concentration is less than normal. The individual cells contain less hemoglobin than they could have under optimal conditions. Hypochromic anemia may be caused by iron deficiency from a low iron intake, diminished iron absorption, or excessive iron loss. It can also be caused by infections or other diseases, therapeutic drugs, lead poisoning, and other conditions. (Stedman, 25th ed; from Miale, Laboratory Medicine: Hematology, 6th ed, p393)

A nutritional condition produced by a deficiency of FOLIC ACID in the diet. Many plant and animal tissues contain folic acid, abundant in green leafy vegetables, yeast, liver, and mushrooms but destroyed by long-term cooking. Alcohol interferes with its intermediate metabolism and absorption. Folic acid deficiency may develop in long-term anticonvulsant therapy or with use of oral contraceptives. This deficiency causes anemia, macrocytic anemia, and megaloblastic anemia. It is indistinguishable from vitamin B 12 deficiency in peripheral blood and bone marrow findings, but the neurologic lesions seen in B 12 deficiency do not occur. (Merck Manual, 16th ed)

An excessive accumulation of iron in the body due to a greater than normal absorption of iron from the gastrointestinal tract or from parenteral injection. This may arise from idiopathic hemochromatosis, excessive iron intake, chronic alcoholism, certain types of refractory anemia, or transfusional hemosiderosis. (From Churchill's Illustrated Medical Dictionary, 1989)

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