Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Standard of Care in Treating Iron Deficiency Anemia

NCT00703937 | Completed Phase 3 Results DMC

• 1 other identifier: 1VIT08019
• Study Type: interventional
• Target: 708
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.

Conditions

Anemia

Outcome Measures

Primary Outcomes (1)

• Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC

  Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent

  First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer

Study Arms (2)

Ferric Carboxymaltose (FCM)

EXPERIMENTAL

750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg).

Drug: Ferric Carboxymaltose (FCM)

Standard Medical Care (SMC) for the treatment of IDA

ACTIVE COMPARATOR

SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA).

Drug: Standard Medical Care (SMC) for the treatment of IDA

Interventions

Ferric Carboxymaltose (FCM) DRUG

Ferric Carboxymaltose (FCM)

Standard Medical Care (SMC) for the treatment of IDA DRUG

Standard Medical Care (SMC) for the treatment of IDA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ≥ 18 years of age and able to give informed consent
• Iron deficiency is the primary etiology of anemia
• Screening Visit central laboratory Hemoglobin (Hgb) ≤ 11g/dL
• Screening Visit ferritin ≤ 100ng/mL or ≤ 300 ng/mL when TSAT was ≤ 30%

You may not qualify if:

• Previous participation in a FCM trial
• Known hypersensitivity reaction to FCM
• Requires dialysis for treatment of chronic kidney disease
• Current anemia not attributed to iron deficiency
• Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
• Anticipated need for surgery
• AST or ALT greater than 1.5 times the upper limit of normal
• Received an investigational drug within 30 days of screening
• Pregnant or sexually-active females who are not willing to use an effective form of birth control

Sponsors & Collaborators

• American Regent, Inc.: lead

Study Sites (1)

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

ferric carboxymaltose; Clinical Trials Data Monitoring Committees

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Professional Staff Committees; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Mark A. Falone, MD
• Organization: Luitpold Pharmaceuticals, Inc.

mfalone@luitpold.com

610-650-4200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 24, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: March 1, 2011
• Last Updated: February 20, 2018
• Results First Posted: November 25, 2013

Record last verified: 2018-01

Locations

US (1)