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Abstract: SA-PO171

Lanthanum Dioxycarbonate Effectively Reduces Urinary Phosphate Excretion in Healthy Volunteers

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Gupta, Pramod, Unicycive Therapeutics Inc., Los Altos, California, United States
  • Khare, Atul, Unicycive Therapeutics Inc., Los Altos, California, United States
Background

~600K kidney failure patients in the US undergo dialysis. Over 43% of these patients have phosphate(P) >5.5 mg/dL, leading to an increased risk of death. Patients rely on dietary restriction and phosphate(P) binders to avoid hyperphosphatemia. However, current P binders often do not achieve normal P levels and have high pill burdens (many large pills per day). A treatment that reduces pill burden while maintaining efficacy would improve patient adherence, quality of life and may be more likely to achieve P goals. Currently available 3000 mg/day lanthanum carbonate effectively reduces urinary P excretion by 236-468 mg/day. Lanthanum dioxycarbonate, RENAZORB(LDC), is a novel nanotechnology product that combines lanthanum, which has the highest binding capacity vs. other P binders, with a potentially smaller pill size that is swallowed with water rather than chewed. We present results of a phase 1 study evaluating LDC’s P binding capacity and tolerability.

Methods

A phase 1, double-blind, placebo-controlled study evaluated LDC’s P binding capacity and tolerability in 4 cohorts of 8 healthy adults. 3 separate LDC doses of 500 mg tablets were administered after meals for 5 days: 1500, 3000, 45000, 6000 mg/day.

Results

All doses reduced the amount of P excreted in urine and increased the amount excreted in feces. Mean overall change in P excretion showed a statistically significant dose-response trend. LDC showed statistically significant mean reduction in urine P excretion with 3000 mg/day (p=0.0004), 4500 mg/day (p<0.0001), and 6000 mg/day (p=0.0001). All treatment-related adverse events (AEs) were mild. There were no severe/life-threatening AEs, serious AEs, deaths, or AEs leading to discontinuation.

Conclusion

LDC was effective in binding to dietary P and the efficacy was dose proportional. It was well tolerated. LDC may be a welcome choice for patients as it is effective and is a small swallowable pill.