Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients

Phase 3

Completed

• Conditions: Anemia
• Interventions: Drug: Ferric Carboxymaltose; Drug: Standard Medical Care (SMC)

• Registration Number: NCT00548691
• Lead Sponsor: American Regent, Inc.

Brief Summary

The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-24
• Primary Completion: 2009-01
• Study Completion: 2009-07
• Results First Submitted: 2013-09-16
• Results First Submitted QC: 2015-05-11
• Results First Posted: 2015-05-13
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-22
• Last Update Posted: 2018-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 513

Inclusion Criteria

• Male or Female 18 to 85 years of age
• NDD-CKD Patients
• TSAT </= 25%
• Hgb </= 11.5
• Ferritin </= 300
• HD-CKD Patients
• TSAT </= 30%
• Hgb </= 12
• Ferritin </= 500

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Exclusion Criteria

• Previous participation in a FCM trial
• Known Hypersensitivity to FCM
• History of anemia other that anemia due to chronic renal failure
• Current history of GI bleeding
• Received IV Iron within the last 30 Days
• Anticipated need for surgery
• Malignancy history
• AST or ALT greater than 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferric Carboxymaltose (FCM)	Ferric Carboxymaltose	Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
Standard Medical Care (SMC)	Standard Medical Care (SMC)	SMC for IDA (as determined by the Investigator) for treating CKD related anemia.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent Serious Adverse Events (SAE's)	from Day 0 through 30 days after the last dose of study drug

Trial Locations

Locations (1)

Luitpold Pharmaceuticals; 🇺🇸 Norristown, Pennsylvania, United States