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| Sponsor: | Luitpold Pharmaceuticals |
|---|---|
| Information provided by: | Luitpold Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00981045 |
Purpose
The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron sucrose (Venofer) in subjects who have iron deficiency anemia (IDA) and impaired renal function.
| Condition | Intervention | Phase |
|---|---|---|
|
Iron Deficiency Anemia Renal Impairment |
Drug: Ferric Carboxymaltose (FCM) Drug: Iron Sucrose (Venofer) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Evaluation of Efficacy and Safety of Ferric Carboxymaltose in Patients With Iron Deficiency Anemia and Impaired Renal Function |
| Estimated Enrollment: | 2500 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ferric Carboxymaltose (FCM)
Intravenous (IV) iron
|
Drug: Ferric Carboxymaltose (FCM)
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
|
Active Comparator: Iron Sucrose (Venofer)
Intravenous (IV) iron
|
Drug: Iron Sucrose (Venofer)
A total cumulative dose of 1000 mg.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Marc Tokars, Luitpold Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00981045 History of Changes |
| Other Study ID Numbers: | 1VIT09030 |
| Study First Received: | September 21, 2009 |
| Last Updated: | March 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
IDA |
|
Anemia Deficiency Diseases Anemia, Iron-Deficiency Renal Insufficiency Hematologic Diseases Malnutrition Nutrition Disorders Anemia, Hypochromic Iron Metabolism Disorders Metabolic Diseases Kidney Diseases Urologic Diseases |
Ferric oxide, saccharated Ferric Compounds Iron Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |