Three-year extension study of lanthanum carbonate therapy in Japanese hemodialysis patients
Lanthanum carbonate is a non-aluminum, non-calcium phosphate binder. Its efficacy and its safety profile up to 1 year have been reported in Japanese hemodialysis patients. The present study was an extension of the earlier study. One hundred and forty-five patients were enrolled in the original 1 year observational Phase III study. After 1 year of treatment, 63 patients continued with further lanthanum treatment. Lanthanum carbonate was administered at 750–4,500 mg/day for up to 156 weeks (3 years). The reduction in serum phosphate was used to evaluate efficacy, and laboratory markers of bone turnover were monitored. The serum phosphate level was maintained at a significantly lower level (P < 0.05) than the baseline level during the 3-year study period. Most of the drug-related adverse events were mild and were mainly gastrointestinal disorders. The safety profile of lanthanum during 3 years of treatment was similar to that seen in the previous study. There were no clinically relevant changes in vital signs or the electrocardiogram. Bone turnover markers, such as osteocalcin, bone-specific alkaline phosphatase, and crosslinked N-telopeptide of type I collagen, showed no clinically relevant changes. Lanthanum therapy was able to reduce and maintain the serum phosphate level within the K/DOQI and JSDT guideline ranges in Japanese dialysis patients for 3 years.