A RANDOMIZED, OPEN LABEL, ACTIVE-CONTROLLED STUDY OF THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF FERUMOXYTOL COMPARED WITH ORAL IRON FOR THE TREATMENT OF IRON DEFICIENCY ANEMIA IN PEDIATRIC SUBJECTS WITH DIALYSIS-DEPENDENT CHRONIC KIDNEY DISEASE

AMAG Pharmaceuticals, Inc.,0 个研究点目标入组 1 人开始时间: 2011年5月4日最近更新: 2023年9月4日

试验速览

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•1. MALE OR FEMALE 6 MONTHS TO <18 YEARS OF AGE
•2. ON PERITONEAL DIALYSIS OR HEMODIALYSIS ≥ 3 MONTHS PRIOR TO THE SCREENING.
•3. HAS IDA DEFINED AS: A) HEMOGLOBIN <11.0 G/DL AND B) TSAT <20%
•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 THE STUDY
•5. SUBJECT AND/OR LEGAL GUARDIAN IS CAPABLE OF UNDERSTANDING AND COMPLYING WITH THE PROTOCOL REQUERIMENTS AND IS AVAILABLE FOR THE DURATION OF THE STUDY.
•6. SUBJECT AND/OR LEGAL GUARDIAN HAS BEEN INFORMED OF THE INVESTIGACIONAL NATURE OF THIS STUDY AND HAS GIVEN VOLUNTARY WRITTEN INFORMED CONSENT AND, IF APPROPRIATE CHILD/ADOLESCENT HAS PROVIDED ´ASSENT´ AND HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) OR PATIENT PROTECTION AUTHORIZATION IN ACCORDANCE WITH INSTITUCIONAL, LOCAL, AND NATIONAL PERSONAL HEALTH DATA PROTECTION GUIDELINES

•1. HISTORY OF ALLERGY TO EITHER ORAL INTRAVENOUS (IV) IRON
•2. ALLERGY TO TWO OR MORE CLASSES OF DRUGS
•3. HEMOGLOBIN ≤ 7.0 G/DL
•4. SERUM FERRITIN LEVEL >600 NG/ML
•5. PARENTERAL IRON THERAPY WITHIN 4 WEEKS PRIOR TO SCREENING; ORAL IRON THERAPY WHITIN 2 WEEKS PRIOR TO SCREENING; OR BLOOD TRANSFUSION WITHIN 2 WEEKS PRIOR TO SCREENING, OR PLANNED DURING THE STUDY
•6. 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
•7. KNOWN CAUSES OF ANEMIA OTHER THAN IRON DEFICIENCY (eg, VITAMIN B12 OR FOLATE DEFICIENCY, HEMOLYTIC ANEMIA, ETC.)
•8. MAJOR SURGERY OF INVASIVE INTERVENTION WHITIN 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
•9. ACTIVE MALIGNANCY WITHIN 2 YEARS PRIOR TO SCREENING (EXCEPT NONMELANOMA SKIN CANCER CARCINOMA IN SITU THAT HAS BEEN EXCISED)
•10. ACTIVE CLINICALLY SIGNIFICANT INFECTION (eg, SYSTEMIC BACTERIAL INFECTION) OR ACUTE SERIOUS MEDICAL ILLNESS REQUIRING TREATMENT OR INTERVENTION WHITIN 2 WEEKS PRIOR TO SCREENING

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