Loading clinical trials...

Compare Efficacy/Safety of Repeat Doses of Ferumoxytol With Iron Sucrose in CKD Subjects With IDA and on Hemodialysis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT01227616•AMAG Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (43)

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Pine Bluff, Arkansas, United States

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Azusa, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Beverly Hills, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Los Angeles, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Los Angeles, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Lynwood, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Northridge, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Paramount, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Sacramento, California, United States

For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

San Diego, California, United States

Key Dates

Start Date

August 1, 2013

Primary Completion Date

February 1, 2016

Completion Date

February 1, 2017

Last Updated

April 21, 2022

Enrollment

296

ACTUAL participants

Conditions

Iron Deficiency Anemia TreatmentChronic Kidney Disease(CKD)

Interventions

Ferumoxytol

DRUG

Iron Sucrose

DRUG

Sponsors

Lead Sponsor

AMAG Pharmaceuticals, Inc.

Related Studies

RECRUITINGPHASE3

Intensification of Blood Pressure Lowering Therapeutics Based on Diuretics Versus Usual Management for Uncontrolled Hypertension IN Patients With Moderate to Severe Chronic Kidney Disease

NCT05732727

Chronic Kidney Disease(CKD)Uncontrolled Hypertension

Monocytes in Subjects With Type 1 Diabetes and Chronic Kidney Disease

NCT06694558

Chronic Kidney Disease(CKD)Type 1 Diabetes (T1D)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions