This study will be conducted to evaluate the safety and tolerability of ferric citrate in pediatric participants with iron deficiency anemia (IDA) associated with non-dialysis dependent chronic kidney disease (NDD-CKD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
oral tablets
administered per the approved label and at the Investigator's discretion
Number of Participants with Serious and Non-serious Treatment-emergent Adverse Events
Time frame: up to Week 28
Number of Participants with Clinically Significant Laboratory Abnormalities or Changes in Laboratory Results
Time frame: up to Week 24
Number of Participants with Treatment-emergent Adverse Events Leading to the Discontinuation of Ferric Citrate
Time frame: up to Week 28
Change from Baseline in Hemoglobin to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
Change from Baseline in Transferrin Saturation (TSAT) to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
Change from Baseline in Ferritin to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
Change from Baseline in Serum Phosphorus to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
Change from Baseline in Calcium to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
Change from Baseline in Bicarbonate to Week 24/Early Termination Visit
Time frame: Baseline; Week 24
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