None listed
Conditions
Interventions
SUBJECTS WHO COMPLETE PARTICIPATION IN EITHER STUDY FER-CKD-251 O-252 FER-CKD-252 WILL HAVE THE OPPORTUNITY TO BE CONSIDERED FOR PARTICIPATION IN THE EXTENSION STUDY. SUBJECTS WILL BE PREFERENTIALLY S
THIS DOSE REGIMEN MAY BE MODIFIED BASED ON EMERGING SAFETY RESULTS FROM THE TWO RANDOMIZED STUDIES (FER-CDK-251 AND FER-CKD-252) IN WHICH THE EFFICACY AND SAFETY OF TWO DOSE REGIMENS OF FERUMOXYTOL (7
Sponsors
AMAG Pharmaceuticals, Inc.,
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. SUBJECT WHO HAVE COMPLETED PARTICIPATION IN STUDY FER-CKD-251 OR FER-CKD-252 WITHIN THE PAST 4 WEEKS 2. FEMALE SUBJECTS OF CHILDBEARING POTENTIAL WHO ARE SEXUALLY ACTIVE MUST BE ON AN EFFECTIVE METHOD OF BIRTH CONTROL AND AGREE TO REMAIN ON BIRTH CONTROL UNTIL COMPLETION OF THE STUDY 3. SUBJECT AND/OR LEGAL GUARDIAN IS CAPABLE OF UNDERSTANDING AND COMPLYING WITH THE PROTOCOL REQUERIMENTS AND IS AVAILABLE FOR THE DURATION OF THE STUDY. 4. 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 PROTECTION GUIDELINES.
Exclusion criteria
Exclusion criteria: 1. EXPERIENCED A SERIOUS ADVERSE EVENT (SAE) RELATED TO INTRAVENOUS (IV) IRON THERAPY IN STUDY FER-CKD-251 OR FER-CKD-252 2. HEMOGLOBIN ≥ 7.0 G/DL 3. MAJOR SURGERY OR INVASIVE INTERVENCION WITIN 4 WEEKS PRIOR TO SCREENING OR DURING THE SCREENING PERIOD 4. DEVELOPMENT OF AN ACTIVE MALIGNANCY DURING PARTICIPATION IN STUDY FER-CKD-251 OR FER-CKD-252 OR PRIOR TO ENROLLMENT IN THIS STUDY (EXCEPT NONMELANOMA SKIN CANCER OR CARCINOMA IN SITU THAT IS EXCISABLE) 5. RECEIVED AN INVESTIGATIONAL AGENT DURING PARTICIPATION IN STUDY FER-CKD-251 OR FER-CKD-252 OR PRIOR TO ENROLLMENT IN THIS STUDY, OTHER THAN AS SPECIFIED BY THE STUDY PROTOCOLS 6. FEMALE SUBJECTS WHO ARE PREGNANT OR INTEND TO BECOME PREGNANT OR HAVE A POSITIVE SERUM OR URINE PREGNANCY TEST. 7. DEVELOPMENT OF ANY OTHER CLINICALLY SIGNIFICANT MEDICAL OR PSYCHIATRIC DISEASE OR CONDITION (eg, UNCONTROLLED HYPERTENSION, PSYCHOSIS) OR SUBJECT RESPONSABILITY THAT, IN THE INVESTIGATO´S OPINION, MAY INTERFERE WITH A SUBJECT´S (AND/ OR LEGAL GUARDIAN´S) ABILITY TO ADHERE THE PROTOCOL, INTERFERE WITH ASSESSMENT OF THE INVESTIGATIONAL PRODUCT OR SERVE AS CONTRAINDICATION TO THE SUBJECT´S PARTICIPATION IN THE STUDY.
Countries
United States
Contacts
Public ContactMarcela Toledo
SYNEOS HEALTH PERU S.R.L.
Outcome results
None listed