Bioequivalency Study Comparing Hospira's Generic Iron Sucrose Injection to Venofer
Summary
The primary objective of this study is to assess the bioequivalence of the test product Hospira Iron Sucrose 20 mg/mL (Hospira, Inc.) to the reference product Venofer® 20 mg/mL following intravenous administration to healthy subjects.
Description
Iron is essential to the synthesis of hemoglobin (Hb) to maintain oxygen transport and to the function and formation of other physiologically important heme and nonheme compounds. Iron deficiency may be caused by blood loss during dialysis, increased erythropoiesis following administration of epoetin, and insufficient absorption of iron from the gastro-intestinal tract. Most dialysis patients require intravenous iron supplementation to replenish iron stores.
Iron sucrose is used to replenish body iron stores in patients with iron deficiency on chronic hemodialysis and receiving erythropoietin. In these patients iron deficiency is caused by blood loss during dialysis procedure, increased erythropoiesis, and insufficient absorption of iron from the gastrointestinal tract. Most hemodialysis patients require intravenous iron to maintain sufficient iron stores to achieve and maintain a hemoglobin level of 11-12 g/dL.
Subjects who fulfill the inclusion/exclusion criteria after screening will be randomized to receive 100 mg of iron sucrose as either Hospira Iron Sucrose or Venofer®.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Healthy Volunteers
Intervention
Iron Sucrose, Iron Sucrose
Location
Bio-Kinetic Clinical Applications
Springfield
Missouri
United States
65802
Status
Active, not recruiting
Source
Hospira, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00719459
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Iron, Dietary
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.
Dietary Sucrose
Sucrose present in the diet. It is added to food and drinks as a sweetener.
Iron Regulatory Protein 2
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.
Iron Regulatory Protein 1
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 RNA binding ability and its aconitate hydrolase activity are dependent upon availability of IRON.
Anemia, Iron-deficiency
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.
Clinical Trials
Safety Efficacy of Iron Sucrose in Children
Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease patients
Trial Comparing the Safety of Two Different Intravenous Iron Formulations
The purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients...
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).
Non-randomized open label Phase II clinical trial in which subjects meeting criteria for RLS were assigned to 1 of three treatment cohorts. The first cohort received one 500 mg IV iron su...
Efficacy and Safety Study of Iron Sucrose and Oral Iron Acetyl-transferrin Hydroglycerin
multi-center, prospective, randomized, open-labeled, active-drug-controlled, two-parallel-group-comparison(venoferrun group vs Bolgre group)study
PubMed Articles
Purpose An analysis of reported adverse events (AEs) among patients using i.v. iron products, including the newer agent ferumoxytol, is presented. Methods All AE reports to the Food and Drug Administr...
Iron sucrose and low-molecular-weight iron dextran (LMW-ID), two commonly used iron solutions, have been compared in terms of allergic adverse event profiles to date. However, the safety of total dose...
Aim: Postpartum anemia is a common problem in obstetrics. Depending on the severity of anemia, it can cause a wide range of symptoms. Obstetrical management should be focused on avoiding blood tran...
Sucrose: Metabolite and signaling molecule.
Sucrose is a molecule that is synthesized only by oxygenic photosynthetic organisms. In plants, sucrose is synthesized in source tissues and then can be transported to sink tissues, where it is utiliz...
A facile aerosol-based process (ABP) is developed to vary the placement of iron nanoparticles on the external surface of carbon microspheres or within the interior. This is accomplished through the co...
