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Efficacy and safety of lanthanum carbonate in pre-dialysis CKD patients with hyperphosphatemia: a randomized trial
Yuki Takahara1, Yoshimi Matsuda, Shunichi Takahashi
1Bayer Yakuhin, Ltd., Osaka, and Division of Nephrology, Department of Internal Medicine, Wakayama Medical University, Wakayama-city, Japan.
Insights
Lanthanum carbonate effectively controls hyperphosphatemia in pre-dialysis chronic kidney disease (CKD) patients. This phosphate binder demonstrated significant serum phosphate reduction and a favorable safety profile in a recent clinical trial.
Area of Science:
- Nephrology
- Pharmacology
Background:
- Hyperphosphatemia is a common complication in chronic kidney disease (CKD).
- Lanthanum carbonate (LC) is an established phosphate binder for dialysis patients.
- Recent approvals extend LC use to non-dialysis CKD patients with hyperphosphatemia.
Purpose of the Study:
- To confirm the efficacy and safety of lanthanum carbonate (LC) in Japanese patients with stage 4-5 CKD not on dialysis.
- To evaluate LC's ability to control elevated serum phosphate levels in this patient population.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial.
- 143 hyperphosphatemic CKD patients (stage 4-5, not on dialysis) were randomized to LC or placebo for 8 weeks.
- Serum phosphate levels were monitored, with doses adjusted as needed.
Main Results:
- Lanthanum carbonate significantly reduced serum phosphate levels compared to placebo (difference: 0.97 mg/dL, p < 0.0001).
- A higher proportion of patients in the LC group achieved target phosphate levels (≤ 4.6 mg/dL) (59.56% vs. 10.46%).
- LC also reduced serum calcium-x-phosphate product and urinary phosphate excretion with a safety profile similar to placebo.
Conclusions:
- Lanthanum carbonate is effective in controlling hyperphosphatemia in pre-dialysis CKD patients.
- The study supports the use of LC for managing hyperphosphatemia in this specific patient group.
Background:
Lanthanum carbonate (LC), an effective non-calcium phosphate binder is widely used to manage hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Recently, the additional indication for control of hyperphosphatemia in CKD patients not on dialysis has been approved.
Methods:
A multicenter, randomized, double-blind, placebo-controlled trial to confirm the efficacy and safety of LC in Japanese hyperphosphatemic stage 4 - 5 CKD patients not on dialysis. After a 4-week run-in period, 143 eligible subjects with serum phosphate levels of 5.6 - 11.0 mg/dL were randomized (2 : 1) to receive LC or placebo (88 vs. 55) for 8 weeks; 119 subjects completed the study (76 vs. 43). The starting LC dose was 750 mg/day, which was then up-titrated to 2,250 mg/day as needed while tolerated. Primary efficacy analysis was performed on the intent-to-treat (ITT) population of 141 patients (86 vs. 55).
Results:
LC produced a significantly greater reduction in serum phosphate level compared with placebo after 8 weeks of treatment (difference, 0.97 (95% CI: 0.58, 1.37) mg/ dL; p < 0.0001). The cumulative proportion of subjects with controlled phosphate levels ≤ 4.6 mg/dL was higher in the LC group than the placebo group (59.56% vs. 10.46%). LC caused significantly greater reductions in serum Ca × P product and urinary phosphate excretion compared with placebo. The safety profile of LC was similar to that of placebo.
Conclusions:
This study demonstrated the effectiveness of LC to control hyperphosphatemia in pre-dialysis CKD patients.
