spd405

Despite 10 years of post-marketing safety monitoring of the phosphate binder lanthanum carbonate, concerns about aluminium-like accumulation and toxicity persist. Here, we present a concise overview of the safety profile of lanthanum carbonate and interim results from a 5-year observational database study (SPD405-404; ClinicalTrials.gov identifier: NCT00567723). The pharmacokinetic paradigms of lanthanum and aluminium are different in that lanthanum is minimally absorbed and eliminated via the hepatobiliary pathway, whereas aluminium shows appreciable absorption and is eliminated by the kidneys...

AIMS: To investigate the evolution of renal osteodystrophy in patients on maintenance dialysis, treated with lanthanum carbonate (LC) vs. standard phosphate-binder therapy (Stx). MATERIALS AND METHODS: This was a 2-year, randomized, prospective, open-label study during which patients on dialysis received LC titrated to a maximum of 3,000 mg/day or their previous phosphate binder treatment with the aim to achieve target phosphorus levels of < or = 5.9 mg/dl. Paired bone biopsy samples for histomorphometric analysis were available at baseline and 1 year (LC 32, Stx 33), and at baseline and 2 years (LC 32, Stx 24)...

BACKGROUND/AIMS: Lanthanum carbonate (LC, FOSRENOL) is an effective phosphate binder for which tolerability and a safety profile have been reported in haemodialysis patients. Patients from previous studies entered a 2-year extension, enabling assessment of efficacy and safety for up to 6 years of LC monotherapy. METHODS: Patients from four previous trials entered this study. RESULTS: Ninety-three patients started the extension, with 22 entering a sixth year of LC treatment...

BACKGROUND: Despite recognized risks associated with hyperphosphataemia in patients with chronic kidney disease (CKD) Stage 5 on dialysis, the achievement of target levels of serum phosphate is poor. It is likely that this is partly due to poor adherence by patients to their phosphate-binder treatment regimens, which often comprise large daily tablet burdens. METHODS: In this multicentre, open-label trial, patients on a stable dialysis regimen were screened while receiving phosphate-binder therapy, then entered into a washout phase...

Patients with Stage 5 chronic kidney disease who have hyperphosphatemia require treatment with phosphate binders to lower serum phosphorus levels. Existing binders are effective but may be associated with important safety disadvantages. Lanthanum carbonate is a phosphate binder with demonstrated efficacy, safety, and tolerability in clinical trials. Changes in cognitive function were evaluated over time using the Cognitive Drug Research computerized cognitive assessment system (Simple Reaction Time, Digit Vigilance Task, Choice Reaction Time, Numeric Working Memory, and Delayed Picture Recognition) in 360 hemodialysis patients who were enrolled in a 2-year, multicenter, comparative study of lanthanum carbonate versus standard therapy...

BACKGROUND: Renal osteodystrophy is a common complication of end-stage renal disease (ESRD) and is a major cause of morbidity in patients with ESRD. High serum levels of phosphorus, calcium and parathyroid hormone are associated with the development of this disease. The effects on bone of treatment with lanthanum carbonate, a new phosphate binder, and calcium carbonate were assessed in patients with ESRD. METHODS: This was an open-label, multicenter, parallel-group study...