None listed
Conditions
Interventions
MALE AND FEMALE SUBJECTS 6 MONTHS TO <18 YEARS OLD AGE WHO ARE NOT ON DIALYSIS, INCLUDING KIDNEY TRANSPLANT RECIPIENTS, HAVE IDA AT SCREENING DEFINED AS HEMOGLOBIN <11.0 G/DL AND TSAT <20%, AND WHO M
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. 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.
Exclusion criteria
Exclusion criteria: 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
Countries
United States
Contacts
Public ContactMarcela Toledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed