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Ferric citrate successfully raises hemoglobin levels, replenishes iron stores, and improves mineral metabolism markers in people with non-dialysis-dependent CKD and IDA.
Chronic kidney disease (CKD) is frequently associated with iron deficiency anemia (IDA), which contributes to fatigue, reduced quality of life, and disease burden in affected patients. Non-dialysis-dependent CKD (NDD-CKD) patients often require effective oral therapies to restore iron balance and improve hemoglobin levels. Ferric citrate (FC) has emerged as a potential treatment option due to its dual role in correcting iron deficiency and managing mineral metabolism abnormalities.
A double-blind, placebo-controlled, randomized Phase III clinical trial aimed to evaluate the efficacy and safety of FC in Taiwanese patients with NDD-CKD and IDA. Subjects were divided in a 1:1 ratio to get either FC (PBF-1681) or placebo for 16 weeks. The study then proceeded to an 8-week open-label extension period during which all the subjects received FC. The initial dose was 2 g/day, with possible dose escalation of an additional 2 g/day on the basis of hemoglobin response and serum phosphate levels.
Outcomes assessed included hemoglobin changes, iron-related biomarkers, mineral metabolism parameters, and safety profiles. In total, 141 subjects were randomized, with 114 completing the double-blind phase and 106 completing the full study period.
The most commonly reported adverse effects were gastrointestinal in nature, including diarrhea, abdominal discomfort, constipation, discolored stools, and abdominal pain. Overall, FC proved to be an effective treatment option for IDA in NDD-CKD patients, leading to meaningful improvements in hemoglobin and iron-related biomarkers. It also showed favorable effects on mineral metabolism parameters, suggesting additional clinical benefits beyond anemia correction. The findings supported FC as a clinically useful therapeutic option for mitigating anemia in CKD, while reinforcing the importance of monitoring gastrointestinal tolerance during therapy.
Kidney Research and Clinical Practice
Ferric citrate for iron deficiency anemia in non-dialysis dependent chronic kidney disease: a randomized phase III study
Mei-Yi Wu et al.
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