An open-label phase 2 trial to assess the efficacy, safety and pharmacokinetics of lanthanum carbonate in hyperphosphatemic children and adolescents with chronic kidney disease undergoing dialysis

• Published in: BMC nephrology 2022-03, Vol.23 (1), p.84-84, Article 84
• Main Authors: Wasilewska, Anna, Murray, Rose Ann, Sundberg, Aimee, Uddin, Sharif, Achenbach, Heinrich, Shavkin, Aleksey, Szabó, Tamás, Vergani, Andrea, Umeh, Obi
• Format: Article
• Language: English
• Subjects: Adolescent; Analysis; Calcium carbonate; Care and treatment; Child; Children; Chronic kidney disease; Chronic kidney failure; Diagnosis; End-stage renal disease; Female; Health aspects; Humans; Hyperphosphatemia - drug therapy; Hyperphosphatemia - etiology; Lanthanum - pharmacokinetics; Lanthanum - therapeutic use; Lanthanum carbonate; Male; Methods; Patient package inserts; Pediatric; Pharmacokinetics; Renal Dialysis; Renal Insufficiency, Chronic - complications; Renal Insufficiency, Chronic - therapy; Risk factors; Testing; Treatment Outcome
• ISSN: 1471-2369; 1471-2369
• DOI: 10.1186/s12882-022-02688-9

This study assessed the efficacy, tolerability and pharmacokinetics (PK) of lanthanum carbonate (LC) in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) undergoing dialysis. This was a three-part, multicenter, open-label study of LC (oral powder formulation) in patients 10 to  12 years old) were summarized. In part 2, patients received calcium carbonate (CC [chewable tablet formulation]) (1500-6500 mg [total daily dose]) followed by LC (powder formulation) (1500-3000 mg [total daily dose]), or LC only (1500-3000 mg [total daily dose]), each for 8 weeks. During part 3, patients received LC (1500-3000 mg [total daily dose]) for up to 6 months. The primary efficacy endpoint was the proportion of LC-treated patients achieving serum phosphorus control after 8 weeks during parts 2 and/or 3, defined as: ≤1.94 mmol/L,