A clinical trial comparing Ferumoxytol with Iron Sucrose for the treatment of Iron Deficiency Anaemia resulting from a lack of stored iron, in adult patients with reduced kidney function.
- Conditions
- Iron Deficiency Anemia (IDA) in Chronic Kidney Disease (CKD) Patients on HemodialysisMedDRA version: 18.0 Level: LLT Classification code 10022974 Term: Iron deficiency anemia System Organ Class: 100000004851Therapeutic area: Body processes [G] - Chemical Phenomena [G02]
- Registration Number
- EUCTR2010-022133-28-GB
- Lead Sponsor
- AMAG Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 293
1. Males and females =18 years of age
2. Subjects with IDA defined as:
a) hemoglobin <11.5 g/dL; and
b) transferrin saturation (TSAT) <30%
3. Serum ferritin <800 ng/mL
4. Subjects must have been on hemodialysis for at least 3 months prior to Screening
5. 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 the study
6. Subject is capable of understanding and complying with the protocol requirements and available for the duration of the study
7. 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) 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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Main Study:
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
4. Untreated vitamin B12 or folate deficiency
5. Erythropoiesis-stimulating agent (ESA) therapy initiated, stopped, or dose changed by >20% within 30 days prior to Screening, or an anticipated ESA dose change of >20% during the initial TP
6. Received an investigational agent within 30 days prior to Screening, or planned receipt of an investigational agent not specified by this protocol during the study period
7. Any other clinically significant medical disease or psychiatric disease or condition (eg, active malignancy, uncontrolled hypertension, acute medical illness/infection, psychosis) or subject responsibility that, in the Investigator’s opinion, may interfere with the subject’s ability to give informed consent or adhere to the protocol, interfere with assessment of the study agent, or serve as a contraindication to the subject’s participation in the study
MRI Substudy:
Additional exclusion criteria for subjects in the MRI Substudy include:
1. Has any contraindication to MR imaging, or otherwise unable to undergo MRI (e.g., pacemaker, recent wound clips, severe claustrophobia, unable to lay flat for sufficient time to undergo imaging)
2. Baseline cardiac T2* value < 20 ms
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method