None listed
Conditions
Interventions
MALE AND FEMALE SUBJECTS 6 MONTHS TO <18 YEARS OF AGE WHO HAVE BEEN ON PERITONEAL DIALYSIS OR HEMODIALYSIS FOR ≥
3 MONTHS PRIOR TO THE SCREENING, HAVE IDA AT SCREENING DEFINED AS HEMOGLOBIN <11.0 G/DL AND TSAT <20%, AND WHO MEET ALL OTHER STUDY ENTRY CRITERIA WILL BE ELIGIBLE FOR STUDY PARTICIPATION.
ELIGIBLE
Sponsors
AMAG Pharmaceuticals, Inc.,
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Contacts
Public ContactMarcela Toledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed