Phase
Condition
Anemia
Treatment
Ferric derisomaltose
NovaFerrum
Ferric carboxymaltose
Clinical Study ID
Ages 16-60 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Observational arm:
Age between 16 and 60 years of age.
Any ethnicity.
Female
Anemic group: hemoglobin ≤10.5 g/dl or hematocrit <32% from finger prick orplethysmography test, or <11 g/dl from venipuncture blood draw
Control group: hemoglobin >13.2 g/dl or hematocrit >39.6%
- Interventional arm:
Criteria for observational component, plus
Iron deficiency anemia based upon attending hematologist interpretation oftransferrin saturation, ferritin, and other ancillary labs including hs-CRP,MMA, hemoglobin electrophoresis
Exclusion
Exclusion Criteria:
- Observational arm:
Diabetes requiring medication.
Hypertension requiring medication.
Sleep disordered breathing requiring intervention.
Body mass index >40 (morbid obesity)
Contraindications to MRI, including pacemaker, severe claustrophobia,pregnancy.
Known systemic inflammatory disease such as inflammatory bowel disease,systemic lupus erythematosus, or scleroderma.
Known HIV.
- Interventional arm:
Criteria for observational component, plus
Prior reaction to intravenous iron.
History of multiple drug allergies.
History of severe asthma, eczema, or atopy.
Systemic mastocytosis.
Severe respiratory or cardiac disease.
Having no access to a physician who can manage the iron deficiency anemia.
Study Design
Study Description
Connect with a study center
City of Hope Blood Donor Center
Duarte, California 91010
United StatesSite Not Available
Cedar Sinai Blood Bank
Los Angeles, California 90027-6062
United StatesSite Not Available
Children's Hospital Los Angeles
Los Angeles, California 90027
United StatesActive - Recruiting
University of California, Los Angeles Blood Donor Center
Los Angeles, California 90095
United StatesSite Not Available
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