MO557: Lanthanum Dioxycarbonate is Safe in Rats

作者：Atul Khare and Gupta Pramod · 发表于：Nephrology, Dialysis and Transplantation · 年份：2022 · DOI：10.1093/ndt/gfac074.002 · 被引用次数：1

Over 7 million patients suffer from end-stage kidney disease (ESKD) worldwide.[1] Due to low kidney function, patients often become hyperphosphatemic, which leads to negative outcomes[2] including increased risk of death.[3] Patients usually rely on dietary restriction and phosphate(P) binders to address hyperphosphatemia. However, current P binders often do not achieve desired P levels[4] and have a high pill burden due to high quantity of large pills.[5,6] Having a therapeutic option using the same quantity of elemental lanthanum as existing therapies (and therefore similar efficacy) but with a potentially smaller and easy-to-administer pills would enhance patient quality of life (QoL). Lanthanum dioxycarbonate, RENAZORB(LDC), is a novel nanotechnology product that combines lanthanum, which has the highest binding capacity versus other P binders,[7] with a potentially smaller pill size that is swallowed rather than chewed to treat hyperphosphatemia in ESRD patients. However, its safety results have not yet been published. We present the results from a toxicity study evaluating safety of lanthanum dioxycarbonate in rats. A repeat-dose toxicology study was conducted to evaluate the potential toxicological profile of LDC. Rats were administered oral doses of LDC at 200, 600 or 2000 mg/kg/day by gavage for approximately 6 weeks. Blood samples for TK analysis were obtained from cohorts of 3 rats/sex/group/time pre-dose and at 1, 2, 4, 8, 12, 24 and 48 h after Day 1 and 38...