A RANDOMIZED, CONTROLLED TRIAL COMPARING IV IRON SUCROSE TO ORAL IRON IN ANEMIC PATIENTS WITH NONDIALYSIS-DEPENDENT CKD

Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S; for the United States Iron Sucrose (Venofer) Clinical Trials Group.

Kidney Int. 2005 Dec;68(6):2846-56.

Although iron deficiency frequently complicates anemia in patients with nondialysis-dependent CKD (ND-CKD), the comparative treatment value of IV iron infusion and oral iron supplementation has not been established.

In a randomized, controlled multicenter trial, we compared the efficacy of iron sucrose, given as 1 g in divided IV doses over 14 days, with that of ferrous sulfate, given 325 mg orally thrice daily for 56 days in patients with ND-CKD stages 3 to 5, Hb < or =11 g/dL, TSAT < or =25%, and ferritin < or =300 ng/mL. Epoetin/darbepoetin therapy, if any, was not changed for eight weeks prior to or during the study.

The proportion of patients achieving the primary outcome (Hb increase > or =1 g/dL) was greater in the IV iron treatment group than in the oral iron treatment group (44.3% vs. 28.0%, P= 0.0344), as was the mean increase in Hb by day 42 (0.7 vs. 0.4 g/dL, P= 0.0298). Compared to those in the IV iron group, patients in the oral iron treatment group showed a greater decline in GFR during the study (-4.40 vs. -1.45 mL/min/1.73m2, P= 0.0100). No serious adverse drug events (ADE) were seen in patients administered IV iron sucrose as 200 mg IV over two to five minutes, but drug-related hypotension, including one event considered serious, occurred in two females weighing less than 65 kg after 500 mg doses were given over four hours.

IV iron administration using 1000 mg iron sucrose in divided doses is superior to oral iron therapy in the management of ND-CKD patients with anemia and low iron indices.

In this randomized, controlled trial, Van Wyck et al. compare the efficacy of 1 g of IV iron sucrose to 325 mg of ferrous sulphate in nondialysis-dependent CKD patients. 44.3% of patients in the IV iron treatment group achieved a hemoglobin (Hb) increase ? 1g/dL compared to 28% in the oral iron treatment group (p = 0.0298). The authors conclude that 1000 mg of IV iron sucrose is more effective than oral iron in managing CKD-associated anemia in patients not on dialysis.