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Lanthanum Carbonate Reduces Phosphorus Burden in Patients with CKD Stages 3 and 4: A Randomized Trial

Stuart M. Sprague^*, Hanna Abboud, Ping Qiu, Matthew Dauphin, Pinggao Zhang, and William Finn

^* Evanston Northwestern Healthcare, Northwestern University Feinberg School of Medicine, Evanston, Illinois; University of Texas Health Science Center at San Antonio, Medicine/Nephrology, San Antonio, Texas; Shire Pharmaceuticals, Wayne, Pennsylvania; and Division of Nephrology & Hypertension, University of North Carolina Kidney Center, Chapel Hill, North Carolina

Correspondence: Stuart M. Sprague, Northwestern University Feinberg School of Medicine, Evanston Northwestern Healthcare, 2650 Ridge Avenue, Evanston, IL 60201. Phone: +1 847 570 2512; Fax: +1 847 570 1696; E-mail: ssprague{at}northwestern.edu

Background and objectives: Lanthanum carbonate (FOSRENOL®, Shire Pharmaceuticals) is an effective noncalcium, nonresin phosphate binder for the control of hyperphosphatemia in chronic kidney disease (CKD) stage 5 patients undergoing dialysis.

Design, setting, participants and measurements: A Phase 2, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of lanthanum carbonate in CKD stage 3 and 4 patients. Of 281 patients screened, 121 were randomized (2:1) to lanthanum carbonate or placebo (80 versus 41). The modified intent-to-treat population included 90 patients (56 versus 34); 71 (43 versus 28) completed the study. After run-in, when any current phosphate binders were discontinued and dietary counseling reinforced, patients with serum phosphorus >4.6 mg/dl received lanthanum carbonate (titrated up to 3000 mg/d) or matching placebo for 8 wk.

Results: At the end of treatment, 25 (44.6%) versus nine (26.5%) patients had serum phosphorus 4.6 mg/dl (difference 18.1%, P = 0.12) in the lanthanum carbonate and placebo groups, respectively. Statistically significant differences were observed between groups in change from baseline to end of treatment for serum phosphorus (P = 0.02), intact parathyroid hormone (P = 0.02), and urinary phosphorus excretion (P = 0.04). The safety profile and tolerability of lanthanum carbonate were similar to that of placebo.

Conclusions: Because <1% of phosphorus is in the extracellular fluid, serum measurements may not accurately reflect total body burden in patients with CKD stages 3 and 4. However, lanthanum carbonate is an effective phosphate binder in this patient population, with a safety profile and tolerability similar to that of placebo.

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