Lanthanum carbonate reduces phosphorus burden in patients with CKD stages 3 and 4: a randomized trial.
OBJECTIVE
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.


METHODS
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 < or =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.
Sprague
Stuart M
SM
Northwestern University Feinberg School of Medicine, Evanston Northwestern Healthcare, Evanston, IL 60201, USA. ssprague@northwestern.edu
Abboud
Hanna
H
Qiu
Ping
P
Dauphin
Matthew
M
Zhang
Pinggao
P
Finn
William
W
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007674:Kidney Diseases / Q000150:complications / Q000628:therapy*; D007811:Lanthanum / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood* / Q000652:urine; D006435:Renal Dialysis; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D010281:Parathyroid Hormone; D010758:Phosphorus; C119467:lanthanum carbonate; D007811:Lanthanum