Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects with Chronic Kidney Disease - AMAG-FER-IDA-302

• Conditions: Iron deficiency anemia(IDA).; MedDRA version: 9.1Level: LLTClassification code 10022975; MedDRA version: 9.1Level: LLTClassification code 10022976

• Registration Number: EUCTR2010-018961-50-IT
• Lead Sponsor: AMAG PHARMACEUTICALS, INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-24
• Last Update Posted: 18 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 790

Inclusion Criteria

1. Males and females =18 years of age
2. Subjects with IDA defined as:
a) hemoglobin <10.0 g/dL
b) TSAT <20%
3. Subjects who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used (includes subjects who remain anemic despite oral iron therapy, have side effects that preclude the use of oral iron therapy, or who cannot otherwise take oral iron)
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
5. Subject is capable of understanding and complying with the protocol requirements and available for the duration of the study
6. Subject has been informed of the investigational nature of this study and has given voluntary written informed consent and, if applicable, Health Insurance Portability and Accountability Act (HIPAA) or patient protection authorization in accordance with institutional, local, and national personal health data protection guidelines
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of allergy to IV iron
2. Allergy to two or more classes of drugs
3. Subjects on dialysis or with an estimated glomerular filtration rate (eGFR)<30 mL/min/1.73 square metre
4. Female subjects who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
5. Hemoglobin =7.0 g/dL
6. Serum ferritin >600 ng/mL
7. Parenteral iron therapy within 4 weeks prior to screening, oral iron therapy within 2 weeks prior to screening, or red blood cell (RBC)/whole blood transfusion
within 2 weeks prior to screening or planned during the study
8. Erythropoiesis-stimulating agent (ESA) therapy initiated, stopped, or dose changed by >20% within 4 weeks prior to screening, or an anticipated ESA dose change of >20% during the study
9. Known causes of anemia other than iron deficiency (eg, hemolysis, vitamin B12 or folate deficiency, etc)
10. Major surgery or invasive intervention within 4 weeks prior to screening, organ transplant within 6 months prior to screening, or any planned surgery or intervention during the course of the study
11. Recent (within 2 months prior to screening) initiation or change in therapy to control bleeding (eg, azathioprine or 6-mercaptopurine for inflammatory bowel disease [IBD], hormonal therapy for abnormal uterine bleeding [AUB]) or expected to change therapy during the study
12. Active clinically significant infection or acute serious medical illness (with the exception of cancer) requiring treatment or intervention within 2 weeks prior to screening
13. Among subjects with cancer (ie, histologic diagnosis of nonhematologic
malignancy), an Eastern Cooperative Oncology Group (ECOG) Performance
Status of >2 or life expectancy <24 weeks; or >2 prior courses/regimens of
chemotherapy or radiation therapy to >40% of the bone marrow within the
previous 2 years, or history of or preparation for bone marrow transplant
14. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an investigational agent not specified by this protocol during the study period
15. Any other clinically significant medical disease or condition (eg, uncontrolled 1. History of allergy to IV iron hypertension) or subject responsibility that, in the Investigator’s opinion, may interfere with a subject’s ability to
give informed consent, adhere to the protocol, interfere with assessment of the investigational product, or serve
as a contraindication to the subject’s participation in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the efficacy and safety of a 1.02 g of IV ferumoxytol, administered as 2 doses of 510 mg each, compared with 1.0 g of iron sucrose, administered as 5 doses of 200 mg each for the treatment of IDA.;Secondary Objective: there are no secondary objectives of the trial;Primary end point(s): Proportion of subjects achieving a =2.0 g/dL increase in hemoglobin at any time from Baseline to Week 5