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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: Completed Phase 3 study of Iron Deficiency Anemia and Impaired Renal Function, sponsored by American Regent.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG Ferric Carboxymaltose (FCM)
  • DRUG Iron Sucrose (Venofer)

Study Locations (1)

Pennsylvania

  • Luitpold Pharmaceuticals, Inc. - Norristown

Trial Details

FieldValue
Enrollment Target 2,561 participants
Start Date 2009-08
Est. Completion 2011-08
Phase Phase 3
American Regent

34 total trials

What the finished NCT00981045 record still lists

NCT00981045 is an interventional study that assigns participants to a tested intervention. Its 2,561 participants enrollment target places it among the larger protocols in the corpus, above the 87-participant average among 24 other Iron Deficiency Anemia trials with a reported enrollment target (2844% higher).

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 a single indexed study location in 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.

Similar trials for Iron Deficiency Anemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00981045's enrollment target sits among peer trials

2,561 1st of 24 higher than 24 of 24 other Iron Deficiency Anemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Iron Deficiency Anemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00981045, the US trial registry maintained by the National Library of Medicine. NCT00981045 (large enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.