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NCT00981045 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function
A Phase 3 study of Iron Deficiency Anemia and Impaired Renal Function, sponsored by American Regent.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,561
- Enrollment target
- 1
- Study location
NCT00981045 is a Phase 3 study of Iron Deficiency Anemia and Impaired Renal Function that has completed, run by American Regent. The registered enrollment target is 2,561 participants, above the 87-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (2844% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00981045, a Phase 3 study of Iron Deficiency Anemia and Impaired Renal Function, has completed, sponsored by American Regent.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,561 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Ferric Carboxymaltose (FCM)
- DRUG Iron Sucrose (Venofer)
Study Locations (1)
Pennsylvania
- Luitpold Pharmaceuticals, Inc. - Norristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,561 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00981045
The ClinicalTrials.gov registry entry for NCT00981045 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,561 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 87-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (2844% higher). The listed sponsor is American Regent, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Iron Deficiency Anemia appearing as the primary indexed condition, and to 2 interventions - of which Ferric Carboxymaltose (FCM) is the first listed.
NCT00981045 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00981045 about?
NCT00981045 is a clinical study titled "Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function". 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.
What is the current status of trial NCT00981045?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,561 participants. The study started on 2009-08. Estimated completion is 2011-08.
What conditions does trial NCT00981045 study?
This clinical trial studies the following conditions: Iron Deficiency Anemia, Impaired Renal Function.
What interventions are being tested in trial NCT00981045?
The interventions under investigation include: Ferric Carboxymaltose (FCM) (DRUG), Iron Sucrose (Venofer) (DRUG).
Who is sponsoring clinical trial NCT00981045?
This trial is sponsored by American Regent, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00981045 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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