Clinical Nephrology – Epidemiology – Clinical Trials

Kidney International (2005) 68, 2846–2856; doi:10.1111/j.1523-1755.2005.00758.x

A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD

DAVID B VAN WYCK*, MICHAEL ROPPOLO*, CARLOS O MARTINEZ*, RICHARD M MAZEY* and STEPHEN MCMURRAY* FOR THE UNITED STATES IRON SUCROSE (VENOFER®) CLINICAL TRIALS GROUP

*University of Arizona College of Medicine, Tucson, Arizona; Renal Associates of Baton Rouge, Baton Rouge, Louisiana; Renal Physicians of Georgia, Macon, Georgia; Nephrology Associates of Mobile, Mobile, Alabama; and Indiana Medical Associates, Fort Wayne, Indiana

Correspondence: David B. Van Wyck, M.D., Kidney Health Institute, LLC, 6720 N Nanini Drive, Tucson, AZ 85704–6128. E-mail:dvanwyck@sprynet.com

Received 13 May 2005; Revised 11 July 2005; Accepted 20 July 2005.

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Abstract

A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD.

Background

 

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.

Methods

 

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 less than or equal to11 g/dL, TSAT less than or equal to25%, and ferritin less than or equal to300 ng/mL. Epoetin/darbepoetin therapy, if any, was not changed for eight weeks prior to or during the study.

Results

 

The proportion of patients achieving the primary outcome (Hb increase greater than or equal to1 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.

Conclusion

 

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.

Keywords:

CKD, anemia, iron, iron deficiency, iron sucrose

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