Publication:

AIM HD-CKD study: assessment of the efficacy and safety of ferric carboxymaltose in iron deficiency anemia management in haemodialysis patients with chronic kidney disease

Background Iron deficiency anemia (IDA) is a common complication in patients with chronic kidney disease (CKD) undergoing hemodialysis (HD). Intravenous (IV) iron supplementation is essential for managing IDA in these patients, and ferric carboxymaltose (FCM) has emerged as a promising treatment option.

Methods This multicentric, retrospective observational study was conducted from April to August 2023, involving 52 adult HD-CKD patients with IDA in India. During dialysis sessions, 48 patients received 4 weekly doses of 100 mg FCM IV push, while 4 patients received 3 doses. Hematological parameters, including haemoglobin (Hb), serum ferritin, transferrin saturation (TSAT), C-reactive protein (CRP), and estimated glomerular filtration rate (eGFR), were measured at baseline and after the final FCM dose. The primary outcome was the change in Hb levels, with secondary outcomes focusing on changes in ferritin, TSAT, CRP, eGFR, and the safety profile of FCM.

Results Following FCM administration, a significant increase was observed in Hb levels (+0.69 g/dl, p<0.001), serum ferritin (+8.61 ng/ml, p=0.003), and TSAT (+3.69%, p<0.001). CRP levels showed a slight, non-significant decrease, while eGFR slightly increased, and neither reached statistical significance. No serious adverse events were reported, indicating a favorable safety profile for FCM.

Conclusion The study demonstrated that 100 mg IV FCM is an effective and safe treatment for managing iron deficiency anemia in Indian HD-CKD patients. The significant improvement in Hb, ferritin, and TSAT levels post-FCM administration supports its use as a reliable therapeutic option in this patient population.