Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis

AMAG Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease(CKD); Iron Deficiency Anemia Treatment

Treatments: Drug: Iron Sucrose; Drug: Ferumoxytol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01227616

AMAG-FER-CKD-401

Details and patient eligibility

About

The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.

Full description

This was a Phase IV, randomized, open-label, active-controlled, multicenter clinical trial designed to evaluate the safety, efficacy, and frequency of use of ferumoxytol compared to iron sucrose for the episodic treatment of IDA in hemodialysis subjects with CKD over a 1-year period. As part of this Main Study, an Oxidative Stress Substudy and an MRI Substudy were conducted. The Oxidative Stress Substudy, to be run concurrently with the initial TP of the Main Study, was to examine the varying degrees to which iron sucrose and ferumoxytol may or may not induce oxidative stress in vitro in subjects undergoing hemodialysis. The MRI Substudy, to be run concurrently with the Main Study and continue for an additional 11 months, was to assess the potential for deposition of iron in cardiac, hepatic, and pancreatic tissues and changes in laboratory parameters over a 2-year period.

Enrollment: 296 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria include:

1. Males and females ≥18 years of age
2. Diagnosis of CKD
3. Subjects on dialysis must have been on dialysis for at least 3 months prior to screening
4. Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. History of allergy to either oral or IV iron
2. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
3. Parenteral iron therapy within 30 days prior to screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to screening or planned during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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296 participants in 2 patient groups

Ferumoxytol

Experimental group

Description:

Intravenous (IV) iron

Treatment:

Drug: Ferumoxytol

IV Iron Sucrose

Active Comparator group

Description:

Intravenous (IV) iron

Treatment:

Drug: Iron Sucrose