E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Iron deficiency anemia in subjects with Chronic kidney disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022974 |
E.1.2 | Term | Iron deficiency anemia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in subjects with chronic kidney disease (CKD)
-To evaluate the safety of a 1.02 g course of IV ferumoxytol compared to 1.0 g IV iron sucrose |
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E.2.2 | Secondary objectives of the trial |
-To evaluate the efficacy of ferumoxytol as compared to iron sucrose by assessing the mean change in hemoglobin from Baseline to Week 5
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Substudy of Markers of Oxidative Stress and Tubular Damage |
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E.3 | Principal inclusion criteria |
A subject will be eligible for enrollment in the study if all of the following criteria apply: 1. Males and females ≥18 years of age 2. An eGFR <60 mL/min or a diagnosis of underlying CKD (eg, nephropathy, nephritis) 3. Hemoglobin <11.0 g/dL 4. TSAT <30% 5. Hemodialysis subjects on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week. 6. 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 7. Subject is capable of understanding and complying with the protocol requirements and available for the duration of the study 8. 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 |
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E.4 | Principal exclusion criteria |
A subject will not be eligible for enrollment in the study if any of the following criteria apply: 1. History of allergy to IV iron 2. Allergy to 2 or more classes of drugs 3. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test 4. Hemoglobin value ≤7.0 g/dL 5. Parenteral iron therapy within 4 weeks prior to screening or oral iron therapy within 2 weeks prior to screening 6. Red blood cell (RBC) or whole blood transfusion within 2 weeks prior to screening or planned during the study 7. 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 8. Receiving peritoneal dialysis (PD) 9. Subjects not on dialysis for whom initiation of dialysis is considered imminent 10. Recent (within 4 weeks of screening) blood loss from causes other than dialysis (eg, gastrointestinal bleeding, recent major surgery, etc) 11. 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 12. Known causes of anemia other than iron deficiency (eg, hemolysis, vitamin B12 or folate deficiency, etc) 13. Active malignancy (except non-melanoma skin cancer or carcinoma in situ that has been excised) 14. Acute serious medical illness requiring intervention or therapy within 2 weeks prior to screening (eg, acute liver disease, coronary event) 15. Any other clinically significant medical disease or condition (eg, uncontrolled hypertension), or label specific contraindication(s), or responsibility that, in the Investigator’s opinion, may interfere with a subject’s ability to adhere to the protocol, interfere with assessment of the investigational product, or serve as a contraindication to the subject’s participation in the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety Endpoints: • AEs of special interest (hypotension, hypersensitivity), SAEs, severe AEs, and AEs leading so study drug discontinuation • All AEs • Vital signs (blood pressure, heart rate, respiration rate, and body temperature) • Physical examination findings • Routine laboratory parameters (hematology, serum chemistry, iron panel, and urinalysis) Efficacy Endpoints • Mean change in hemoglobin from Baseline to Week 5 • Proportion of subjects with an increase in hemoglobin ≥1.0 g/dL during the period from Baseline to Week 5 Exploratory Endpoints • Health care utilization, including hospitalizations, procedures, and outpatient visits
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |