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

American Regent

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Ferric Carboxymaltose; Drug: Standard Medical Care (SMC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00548691

1VIT07018

Details and patient eligibility

About

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

Enrollment: 513 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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513 participants in 2 patient groups

Ferric Carboxymaltose (FCM)

Experimental group

Description:

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.

Treatment:

Drug: Ferric Carboxymaltose

Standard Medical Care (SMC)

Active Comparator group

Description:

SMC for IDA (as determined by the Investigator) for treating CKD related anemia.

Treatment:

Drug: Standard Medical Care (SMC)