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A Phase 2 Clinical Trial of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia.

A Phase 2 Clinical Trial of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia. Clinical journal of the American Society of Nephrology : CJASN Block, G. A., Chertow, G. M., Reddy, G., Hasal, S. J., Mourya, S., Block, M., Gupta, S., Pergola, P. E. 2025

Abstract

In patients with kidney failure receiving maintenance dialysis, hyperphosphatemia is managed by dietary phosphate restriction and the provision of phosphate binders. Oxylanthanum carbonate (OLC) is a phosphate binder in development with high potency and formulated in a small pill swallowed whole.We conducted a Phase 2, open-label, single-arm, multicenter trial in adult patients receiving maintenance hemodialysis with hyperphosphatemia. The primary objective was to evaluate the tolerability of OLC at clinically effective doses with a goal serum phosphate concentration (sP) =5.5 mg/dL. The trial included washout, titration, and maintenance periods. Eligible patients had sP =4.0 and =7.5 mg/dL for at least eight weeks prior to screening while receiving thrice weekly hemodialysis and a stable phosphate binder regimen. Patients started titration when sP was >5.5 mg/dL and entered maintenance once sP was =5.5 mg/dL. The starting dose of OLC during titration was 1500 mg/day (500 mg thrice daily). We assessed tolerability based on the incidence of discontinuations due to treatment-related adverse events (TRAEs).Eighty-six patients were treated with OLC during the study. At screening, sP was =5.5 mg/dL in 51 (59%) patients. Seventy-eight (91%) patients entered maintenance, and 71 (91%) patients achieved sP =5.5 mg/dL on a median OLC dose of 500 mg TID. The most common TRAEs were gastrointestinal and included diarrhea (9%) and vomiting (6%); all other TRAEs were reported in <5% of patients. Three (4%) patients discontinued drug due to TRAEs. Minimal to no systemic absorption of lanthanum was observed following administration of OLC 1000 mg thrice daily.In this open-label Phase 2 trial, OLC was well tolerated and enabled sP control in >90% of patients with a low pill burden (two-thirds of patients receiving three or fewer tablets/day).

View details for DOI 10.2215/CJN.0000000780

View details for PubMedID 40658981