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Last Updated: August 8, 2020

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CLINICAL TRIALS PROFILE FOR VENOFER

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505(b)(2) Clinical Trials for Venofer

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT01067547 A Trial of Iron Replacement in Patients With Iron Deficiency. Completed Richard Fedorak Phase 4 2010-03-01 Primary Hypothesis: There is no difference in the efficacy of iron replacement by oral or intravenous route in Inflammatory Bowel Disease patients. Iron deficiency anaemia is a common problem in people with inflammatory bowel disease (IBD) and patients with excessive blood loss from the bowel or heavy menstrual loss. Treatment options include a blood transfusion, oral iron with (Ferrograd ®) or intravenous iron replacement with iron sucrose (Venofer®). Iron deficiency anaemia is associated with poor quality of life, poor concentration span and low energy level. Blood transfusion may improve symptomatic anaemia quickly but there is a risk of transfusion reaction and blood born infection transmission. Moreover, packed cells are scarce resource therefore its use needs to be carefully prioritized. Oral iron supplement has been widely used and it can be purchased over the counter, however, its efficacy is not known in IBD population. Oral iron is poorly tolerated with side effects include altered bowel habit, nausea and darken stools, making it difficult to adhere to. In contrast, intravenous iron therapy with Venofer® has been shown to replenish iron store and improve anaemia quickly. To date, the safety of Venofer® use has been supported by its post marketing surveillance. Limitations with intravenous iron replacement include the need for medical supervision in the setting of limited healthcare resources; the need for patients to take multiple days off work and the cost of Venofer®. Currently it is uncertain which method of iron replacement is better. The purpose of this study is to compare the efficacy and the cost of oral and intravenous iron replacement in the setting of iron deficiency anaemia.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Venofer

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00145652 Adjuvant I.V. Iron Therapy During Erythropoetin Treatment of Anemic Patients With Lymphoproliferative Disorders. Completed Sundsvall Hospital Phase 3 2003-12-01 This is a multi-center open label, randomized phase-3 study with stratification according to diagnosis and baseline serum-EPO level. The correction of mild or moderate anemia and the effect on iron kinetics by the rHuEPO treatment with or without intravenous iron supplementation in anemic patients with LPD not receiving antineoplastic therapy will be studied. The study will be performed according to the ICH-GCP guidelines. In order to be eligible, the patient must consent in writing that he/she agrees to participate in the study. The patient recruitment period is estimated to be no longer than 18 months.
NCT00236938 Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis Completed Luitpold Pharmaceuticals Phase 3 2002-07-01 This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.
NCT00318812 Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure Completed Ottawa Hospital Research Institute Phase 2/Phase 3 2007-05-01 The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as intravenous (IV) iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disease.
NCT00384657 Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease Recruiting Anemia Working Group Romania Phase 3 2008-01-01 Recently, growing body of evidence support the finding that anemia frequently occurs in patients with chronic heart failure (CHF). Chronic kidney disease (CKD), as well, is highly prevalent among heart failure patients, and both anemia and CKD are independently associated with increased mortality. A vicious circle is established with CHF causing both chronic renal insufficiency and anemia, and CKD further aggravating anemia which, in turn, worsens CHF and so on. Treatment of the anemia breaks this circle and improves the quality of life, cardiac and renal functions in patients with severe CHF. Intravenous iron alone was proved to allow the maintenance of target hematocrit in one-third of chronic renal failure predialysis patients. Based on these considerations, intravenous iron for anemia in patients with CHF and moderate CKD would represent a reasonable therapeutic approach. The aim of the trial is to assess the efficiency of intravenous iron therapy in the management of mild to moderate anemia associated with CHF NYHA III class and concomitant moderate CKD.
NCT00557817 Erythropoietin (Epo) and Venofer Trial After Autologous Hematopoietic Stem Cell Transplantation (HSCT) Completed Amgen Phase 2/Phase 3 2004-03-01 Darbepoetin-alpha and i.v. iron administration after autologous hematopoietic stem cell transplantation for hematological malignancies : a prospective randomized trial.
NCT00557817 Erythropoietin (Epo) and Venofer Trial After Autologous Hematopoietic Stem Cell Transplantation (HSCT) Completed Katholieke Universiteit Leuven Phase 2/Phase 3 2004-03-01 Darbepoetin-alpha and i.v. iron administration after autologous hematopoietic stem cell transplantation for hematological malignancies : a prospective randomized trial.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Venofer

Condition Name

Condition Name for Venofer
Intervention Trials
Anemia 10
Iron Deficiency Anemia 5
Iron Deficiency 4
Chronic Kidney Disease 3
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Condition MeSH

Condition MeSH for Venofer
Intervention Trials
Anemia, Iron-Deficiency 16
Anemia 15
Kidney Diseases 7
Deficiency Diseases 7
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Clinical Trial Locations for Venofer

Trials by Country

Trials by Country for Venofer
Location Trials
United States 12
Austria 3
Canada 2
Spain 2
Thailand 1
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Trials by US State

Trials by US State for Venofer
Location Trials
Massachusetts 4
Pennsylvania 4
Florida 1
New York 1
Indiana 1
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Clinical Trial Progress for Venofer

Clinical Trial Phase

Clinical Trial Phase for Venofer
Clinical Trial Phase Trials
Phase 4 9
Phase 3 11
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Venofer
Clinical Trial Phase Trials
Completed 19
Not yet recruiting 6
Recruiting 5
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Clinical Trial Sponsors for Venofer

Sponsor Name

Sponsor Name for Venofer
Sponsor Trials
Luitpold Pharmaceuticals 4
AMAG Pharmaceuticals, Inc. 4
Vifor Inc. 2
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Sponsor Type

Sponsor Type for Venofer
Sponsor Trials
Other 24
Industry 21
NIH 1
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