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Three-year extension study of lanthanum carbonate therapy in Japanese hemodialysis patients
1Division of Nephrology and Blood Purification Medicine, Department of Medicine, Wakayama Medical University, 881-1 Kimiidera, Wakayama, Wakayama 641-8509, Japan. taki@wakayama-med.ac.jp
Insights
Lanthanum carbonate effectively lowered serum phosphate in Japanese dialysis patients for three years. The treatment demonstrated a favorable safety profile with mostly mild gastrointestinal events, maintaining phosphate levels within guidelines.
Area of Science:
- Nephrology
- Pharmacology
- Biochemistry
Background:
- Lanthanum carbonate is a phosphate binder for dialysis patients.
- Previous studies reported its efficacy and safety up to one year in Japanese hemodialysis patients.
Purpose of the Study:
- To evaluate the long-term efficacy and safety of lanthanum carbonate.
- To assess serum phosphate reduction and bone turnover markers over three years.
Main Methods:
- An extension study of 63 patients from a 1-year Phase III trial.
- Lanthanum carbonate administered at 750-4,500 mg/day for up to 156 weeks.
- Efficacy assessed by serum phosphate reduction; safety monitored via adverse events and laboratory markers.
Main Results:
- Serum phosphate levels were significantly reduced and maintained below baseline throughout the 3-year study (P < 0.05).
- The safety profile was consistent with previous findings, with mild gastrointestinal disorders being the most common adverse events.
- No clinically significant changes were observed in vital signs, ECG, or bone turnover markers.
Conclusions:
- Lanthanum therapy effectively reduced and maintained serum phosphate levels within recommended guidelines for Japanese dialysis patients over three years.
- The long-term safety profile of lanthanum carbonate is favorable.
Background:
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.
Methods:
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.
Results:
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.
Conclusion:
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.
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