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Ferric Carboxymaltose Assessment for Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease

2014-08-27 03:18:41 | BioPortfolio

Summary

Phase IIIb (1016 pts, 19 countries) study to evaluate the long-term efficacy of FCM (using targeted ferritin levels to determine dosing) or oral iron in NDD-CKD subjects with iron deficiency anaemia (IDA).

Description

Open-label, multicentre, randomised, 3-arm design study to assess the use of FCM (using targeted ferritin levels to determine dosing) or oral iron to delay and/or reduce ESA use in NDD-CKD subjects with IDA.

Post an initial screening period (up to 4 weeks) eligible subjects will be randomised (1:1:2) to 1 of the following 3 treatment arms for a period of 52 weeks.

1. High dosage (1,000 mg of iron) regimen of intravenous FCM targeting a ferritin level of 400-600 mcg/L.

2. Low dosage (200 mg of iron) regimen of intravenous FCM targeting a ferritin level of 100-200 mcg/L.

3. Daily oral iron (180-200 mg elemental iron).

Study Design

Allocation: Randomized, Control: Active Control, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Iron Deficiency Anemia

Intervention

Ferinject, Ferinject, Oral Iron

Location

Liverpool Health Service
Liverpool
New South Wales
Australia
2170

Status

Recruiting

Source

Vifor Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:41-0400

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Medical and Biotech [MESH] Definitions

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 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.

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)

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)

A multifunctional iron-sulfur protein that is both an iron regulatory protein and cytoplasmic form of aconitate hydratase. It binds to iron regulatory elements found on mRNAs involved in iron metabolism and regulates their translation. Its rate of degradation is increased in the presence of IRON.

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