Abstract
BackgroundHyperphosphatemia in patients with chronic kidney disease (CKD) contributes to secondary hyperparathyroidism, soft tissue calcification, and increased mortality risk. This trial was conducted to examine the efficacy and safety of calcium acetate in controlling serum phosphorus in pre-dialysis patients with CKD.MethodsIn this randomized, double-blind, placebo-controlled trial, 110 nondialyzed patients from 34 sites with estimated GFR < 30 mL/min/1.73 m2 and serum phosphorus > 4.5 mg/dL were randomized to calcium acetate or placebo for 12 weeks. The dose of study drugs was titrated to achieve target serum phosphorus of 2.7-4.5 mg/dL. Serum phosphorus, calcium, iPTH, bicarbonate and serum albumin were measured at baseline and every 2 weeks for the 12 week study period. The primary efficacy endpoint was serum phosphorus at 12 weeks. Secondary endpoints were to measure serum calcium and intact parathyroid hormone (iPTH) levels.ResultsAt 12 weeks, serum phosphorus concentration was significantly lower in the calcium acetate group compared to the placebo group (4.4 ± 1.2 mg/dL vs. 5.1 ± 1.4 mg/dL; p = 0.04). The albumin-adjusted serum calcium concentration was significantly higher (9.5 ± 0.8 vs. 8.8 ± 0.8; p < 0.001) and iPTH was significantly lower in the calcium acetate group compared to placebo (150 ± 157 vs. 351 ± 292 pg/mL respectively; p < 0.001). At 12 weeks, the proportions of subjects who had hypocalcemia were 5.4% and 19.5% for the calcium acetate and the placebo groups, respectively, while the proportions of those with hypercalcemia were 13.5% and 0%, respectively. Adverse events did not differ between the treatment groups.ConclusionsIn CKD patients not yet on dialysis, calcium acetate was effective in reducing serum phosphorus and iPTH over a 12 week period.Trial Registrationwww.clinicaltrials.gov NCT00211978.
Highlights
Hyperphosphatemia in patients with chronic kidney disease (CKD) contributes to secondary hyperparathyroidism, soft tissue calcification, and increased mortality risk
Based on pill counts obtained at each visit, compliance during the 12 week study period was similar in the two groups: 88.6 ± 15.0% in the calcium acetate group and 89.3 ± 14.0% in the placebo group
KDOQI guidelines recommend that serum phosphorus be maintained within the target range of 2.7 to 4.6 mg/ dL in stages 3 and 4 CKD and 3.5 to 5.5 mg/dL in stage 5 CKD by means of dietary phosphate restriction, dialysis and use of phosphate binders [24]
Summary
Hyperphosphatemia in patients with chronic kidney disease (CKD) contributes to secondary hyperparathyroidism, soft tissue calcification, and increased mortality risk. This trial was conducted to examine the efficacy and safety of calcium acetate in controlling serum phosphorus in pre-dialysis patients with CKD. More important is the association between high serum phosphorus and increased risk of cardiovascular events and mortality, both in the CKD population [5,22] as well as in individuals with normal renal function [23]. Treatment with phosphorus binders was recently shown to be independently associated with improved survival among incident hemodialysis patients [6] If these findings can be substantiated, the potential benefits of phosphate binders may extend to the non-dialyzed CKD population. Due to the scarcity of high-level evidence on the beneficial effect of phosphate binders on hard study outcomes, none of the currently available phosphate binders have received approval by the U.S Food and Drug Administration (FDA) for use in patients with CKD who do not require dialysis
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