Efficacy and safety of lanthanum carbonate for reduction of serum phosphorus in patients with chronic renal failure receiving hemodialysis

Finn, William F.; Joy, Melanie S.; Hladik, Gerald A.

doi:10.5414/cnp62193

Cited by 97 publications

(74 citation statements)

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“…At the end of treatment, the mean plasma lanthanum concentration of the lanthanum carbonate group (0.37 Ϯ 0.05 ng/ml) was within the range observed in previous trials of similar duration involving patients with CKD stage 5 (20).…”

Section: Safety and Tolerabilitysupporting

confidence: 82%

Lanthanum Carbonate Reduces Phosphorus Burden in Patients with CKD Stages 3 and 4

Sprague¹,

Abboud²,

Qiu³

et al. 2009

Clinical Journal of the American Society of Nephrology

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Section: Safety and Tolerabilitysupporting

confidence: 82%

Lanthanum Carbonate Reduces Phosphorus Burden in Patients with CKD Stages 3 and 4

Sprague¹,

Abboud²,

Qiu³

et al. 2009

Clinical Journal of the American Society of Nephrology

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“…For patients on a Tuesday-Thursday-Saturday schedule, blood sampling took place on either a Thursday or Saturday. Precedent exists for brief study designs (or per agent crossover treatment periods) of a few weeks in phosphate binder studies 2,9 especially in Phase II 10 or dose-ranging designs. In addition, the majority of the phosphate-binding effect by a given dose of sevelamer hydrochloride, 11 sevelamer carbonate, 2,12 and other agents 13 has been observed to occur within 1 week, with a smaller, incremental effect observed at 2 weeks.…”

Section: Methodsmentioning

confidence: 99%

A randomized, double-blind, placebo-controlled, dose-ranging study using Genz-644470 and sevelamer carbonate in hyperphosphatemic chronic kidney disease patients on hemodialysis

Moustafa¹,

Lehrner

Al-Saghir

et al. 2014

IJNRD

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Background Genz-644470 is a new, nonabsorbed phosphate binding polymer. In an in vitro competitive phosphate binding assay, Genz-644470 bound significantly more phosphate per gram than sevelamer. As a consequence, this clinical study evaluated the ability of Genz-644470 to lower serum phosphorus in patients on hemodialysis and compared serum phosphorus lowering of Genz-644470 with sevelamer carbonate and placebo. Because three different fixed doses of Genz-644470 and sevelamer carbonate were used, phosphate-lowering dose-responses of each agent were also analyzed. Methods A randomized, double-blind, dose-ranging study was conducted. After a 2-week phosphate binder washout, 349 hyperphosphatemic (serum phosphorus >5.5 mg/dL) hemodialysis patients were randomized to one of seven fixed-dose groups: placebo, Genz-644470 2.4 g/day, Genz-644470 4.8 g/day, Genz-644470 7.2 g/day, sevelamer carbonate 2.4 g/day, sevelamer carbonate 4.8 g/day, or sevelamer carbonate 7.2 g/day. Indicated total daily doses were administered in fixed divided doses three times a day with meals for 3 weeks. The change in serum phosphorus during the treatment period and its dose-response patterns were assessed. Results Dose-dependent reductions in serum phosphorus were observed with both Genz-644470 and sevelamer carbonate. Serum phosphorus-lowering responses to fixed doses of sevelamer carbonate and Genz-644470 were enhanced in a roughly linear fashion with increasing doses over a threefold range after 3 weeks of treatment. Genz-644470 did not show any advantage in phosphorus lowering per gram of binder compared with sevelamer carbonate. Overall toler-ability was similar between active treatment groups. The tolerability of sevelamer carbonate was consistent with prior studies and with the established safety profile of sevelamer. Conclusion Both Genz-644470 and sevelamer carbonate effectively lowered serum phosphate levels in a dose-dependent fashion in patients with chronic kidney disease on hemodialysis. However, Genz-644470 did not provide any advantage over sevelamer carbonate in phosphate lowering in vivo, as had been demonstrated in vitro.

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“…Extensive clinical data support its efficacy and tolerability in both short-term (6,7) and long-term (8,9) treatment of hyperphosphatemia in patients with stage 5 CKD. Reformulated (500 mg) and higher strength (750 and 1000 mg) lanthanum carbonate tablets have been available since 2006.…”

mentioning

confidence: 98%

Higher Strength Lanthanum Carbonate Provides Serum Phosphorus Control With a Low Tablet Burden and Is Preferred by Patients and Physicians

Mehrotra

Martin

Fishbane

et al. 2008

Clinical Journal of the American Society of Nephrology

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Results: At the end of week 4, 54% of patients achieved serum phosphorus control at dosages <3000 mg/d administered as one tablet per meal. Among patients who entered cohort B, control rates of 25, 38, and 32% for patients who were randomly assigned to 3000, 3750, or 4500 mg/d lanthanum carbonate, respectively, were achieved, with no increase in adverse events. Patients and physicians reported significantly higher levels of satisfaction with reformulated lanthanum carbonate compared with previous phosphate binders, partly because of reduced tablet burden with higher dosage strengths. Physicians and patients also expressed a preference for lanthanum carbonate over previous medication.Conclusions: Reformulated lanthanum carbonate is an effective phosphate binder that may reduce daily tablet burden.

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Efficacy and safety of lanthanum carbonate for reduction of serum phosphorus in patients with chronic renal failure receiving hemodialysis

Cited by 97 publications

References 0 publications

Lanthanum Carbonate Reduces Phosphorus Burden in Patients with CKD Stages 3 and 4

Lanthanum Carbonate Reduces Phosphorus Burden in Patients with CKD Stages 3 and 4

A randomized, double-blind, placebo-controlled, dose-ranging study using Genz-644470 and sevelamer carbonate in hyperphosphatemic chronic kidney disease patients on hemodialysis

Higher Strength Lanthanum Carbonate Provides Serum Phosphorus Control With a Low Tablet Burden and Is Preferred by Patients and Physicians

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