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 NONDIALYSIS-DEPENDENT CHRONIC KIDNEY DISEASE
- Registration Number
- PER-019-11
- Lead Sponsor
- AMAG Pharmaceuticals, Inc.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 3
1. MALE OR FEMALE 6 MONTHS TO <18 YEARS OF AGE
2. NONDIALYSIS-DEPENDENT CKD, INCLUDING KIDNEY TRANSPLANT RECIPIENTS
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 ONE MONTH PRIOR TO THE 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 AVAILABLE FOR THE DURATION OF THE STUDY.
6. SUBJECT AND/OR LEGAL GUARDIAN HAS BEEN INFORMED OF THE INVESTIGATIONAL 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 DATA PROTECTION GUIDELINES.
1. HISTORY OF ALLERGY TO EITHER ORAL OR IV IRON
2. ALLERGY TO TWO OR MORE CLASSES OF DRUGS
3. ON HEMODIALYSIS OR PERITONEAL DIALYSIS
4. HEMOGLOBIN ≤ 7.0 G/DL
5. SERUM FERRITIN LEVEL >600 NG/RNL
6. PARENTERAL IRON THERAPY WITHIN 4 WEEKS PRIOR TO THE SCREENING; OR BLOOD TRANSFUSION WITHIN 2 WEEKS PRIOR TO THE SCREENING, OR PLANNED DURING THE STUDY
7. ERYTHROPOIESIS-STIMULATING AGENT THERAPY INITIATED, STTOPED, OR DOSE CHANGED BY > 20 % WITHIN 4 WEEKS PRIOR TO SCREENING, OR AN ANTICIPATED ESA DOSE CHANGE OF >20% DURING THE STUDY.
8. KNOWN CAUSES OF ANEMIA OTHER THAN IRON DEFICIENCY (eg, VITAMIN B12 OR FOLATE DEFICIENCY, HEMOLYTIC ANEMIA, ETC.)
9. 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
10. ACTIVE MALIGNANCY WITHIN 2 YEARS PRIOR TO SCREENING (EXCEPT NONMELANOMA SKIN CANCER OR CARCINOMA IN SITU THAT HAS BEEN EXCISED)
11. ACTIVE CLINICALLY SIGNIFICANT INFECTION (eg, SYSTEMIC BACTERIAL INFECTION) OR ACUTE SERIOUS MEDICAL ILLNESS REQUIRING TREATMENT OR INTERVENTION WITHIN 2 WEEKS PRIOR TO SCREENING
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method