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Last Updated: April 15, 2024

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 American Regent, Inc. 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.
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.
NCT00236977 ↗ Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia Completed American Regent, Inc. Phase 3 2003-08-01 To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Venofer

Condition Name

Condition Name for Venofer
Intervention Trials
Anemia 13
Iron Deficiency Anemia 6
Iron Deficiency 5
Chronic Kidney Disease 3
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Condition MeSH

Condition MeSH for Venofer
Intervention Trials
Anemia 21
Anemia, Iron-Deficiency 19
Deficiency Diseases 9
Kidney Diseases 8
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Clinical Trial Locations for Venofer

Trials by Country

Trials by Country for Venofer
Location Trials
United States 79
Canada 7
United Kingdom 5
Spain 4
Poland 4
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Trials by US State

Trials by US State for Venofer
Location Trials
Pennsylvania 9
Massachusetts 6
Florida 5
New York 5
Texas 4
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Clinical Trial Progress for Venofer

Clinical Trial Phase

Clinical Trial Phase for Venofer
Clinical Trial Phase Trials
Phase 4 10
Phase 3 13
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Venofer
Clinical Trial Phase Trials
Completed 27
Recruiting 6
Terminated 4
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Clinical Trial Sponsors for Venofer

Sponsor Name

Sponsor Name for Venofer
Sponsor Trials
AMAG Pharmaceuticals, Inc. 5
American Regent, Inc. 5
Luitpold Pharmaceuticals 5
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Sponsor Type

Sponsor Type for Venofer
Sponsor Trials
Other 38
Industry 32
NIH 1
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