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Efficacy and safety of lanthanum carbonate in pre-dialysis CKD patients with hyperphosphatemia: a randomized trial.
Clin Nephrol. 2014 Sep; 82(3):181-90.CN

Abstract

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.

Authors+Show Affiliations

Bayer Yakuhin, Ltd., Osaka, and Division of Nephrology, Department of Internal Medicine, Wakayama Medical University, Wakayama-city, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25079863

Citation

Takahara, Yuki, et al. "Efficacy and Safety of Lanthanum Carbonate in Pre-dialysis CKD Patients With Hyperphosphatemia: a Randomized Trial." Clinical Nephrology, vol. 82, no. 3, 2014, pp. 181-90.
Takahara Y, Matsuda Y, Takahashi S, et al. Efficacy and safety of lanthanum carbonate in pre-dialysis CKD patients with hyperphosphatemia: a randomized trial. Clin Nephrol. 2014;82(3):181-90.
Takahara, Y., Matsuda, Y., Takahashi, S., & Shigematsu, T. (2014). Efficacy and safety of lanthanum carbonate in pre-dialysis CKD patients with hyperphosphatemia: a randomized trial. Clinical Nephrology, 82(3), 181-90.
Takahara Y, et al. Efficacy and Safety of Lanthanum Carbonate in Pre-dialysis CKD Patients With Hyperphosphatemia: a Randomized Trial. Clin Nephrol. 2014;82(3):181-90. PubMed PMID: 25079863.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of lanthanum carbonate in pre-dialysis CKD patients with hyperphosphatemia: a randomized trial. AU - Takahara,Yuki, AU - Matsuda,Yoshimi, AU - Takahashi,Shunichi, AU - Shigematsu,Takashi, AU - ,, PY - 2014/8/1/entrez PY - 2014/8/1/pubmed PY - 2014/10/25/medline SP - 181 EP - 90 JF - Clinical nephrology JO - Clin Nephrol VL - 82 IS - 3 N2 - 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. SN - 0301-0430 UR - https://www.unboundmedicine.com/medline/citation/25079863/Efficacy_and_safety_of_lanthanum_carbonate_in_pre_dialysis_CKD_patients_with_hyperphosphatemia:_a_randomized_trial_ L2 - http://www.dustri.com/nc/journals-in-english.html?artId=12548 DB - PRIME DP - Unbound Medicine ER -