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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, With MRI Substudy, of Repeated Doses of Ferumoxytol Compared With Iron Sucrose for Treatment of IDA in CKD Patients on Hemodialysis

Conditions
-----------------
Iron Deficiency Anemia Treatment, Chronic Kidney Disease(CKD)

Intervention / Treatment
-----------------
* Drug: Ferumoxytol
* Drug: Iron Sucrose


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria include: Males and females ≥18 years of age Diagnosis of CKD Subjects on dialysis must have been on dialysis for at least 3 months prior to screening 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: History of allergy to either oral or IV iron Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferumoxytol<br>Intravenous (IV) iron | Drug: Ferumoxytol<br>* IV Ferumoxytol<br>* Other names: Feraheme;|
| Active Comparator: IV Iron Sucrose<br>Intravenous (IV) iron | Drug: Iron Sucrose<br>* IV Iron Sucrose<br>* Other names: Venofer;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Changes | Changes in the mean hemoglobin between Baseline and Week 5 for ferumoxytol and iron sucrose in each treatment period. | Up to 6 treatment periods (5 weeks per treatment period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Transferrin Saturation (TSAT) | Mean change in TSAT from TP Baseline to Week 5 for each TP | Up to 6 treatment periods (5 weeks per treatment period) | 
| Proportion of Subjects With an Increase in Hemoglobin of ≥1.0 g/dL at Any Time From TP Baseline to Week 5 for Each TP | The proportion of subjects by group achieving a ≥1.0 g/dL increase in hemoglobin at any point during each 5-week treatment period. | Up to 6 treatment periods (5 weeks per treatment period) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iron deficiency anemia (IDA), chronic kidney disease (CKD), hemodialysis, magnetic resonance imaging (MRI), ferumoxytol, Feraheme