Clinical journal of the American Society of Nephrology : CJASN · 2025-07-14
An open-label, single-arm phase 2 study evaluated OLC tolerability and phosphate control in maintenance-hemodialysis patients. Most treated patients achieved the study phosphate target with a low tablet burden; gastrointestinal adverse events and treatment discontinuations were reported.
Program relevance
Phase 2 NCT06218290 studies oral OLC in dialysis patients with hyperphosphatemia, matching the catalog program.
Formulation / population: Oral oxylanthanum carbonate tablets in maintenance-hemodialysis patients.
Single-arm, open-label study; no randomized comparator.
A short randomized phase 1 dose-escalation study in healthy volunteers evaluated OLC safety and phosphate binding. The abstract reports reduced phosphate absorption and low systemic lanthanum exposure. It does not establish long-term outcomes in dialysis patients.
Program relevance
The same compound was studied in healthy volunteers, not dialysis patients or an FDA manufacturing review.
Formulation / population: Oral OLC tablets in healthy volunteers over a short dose-escalation study.
Healthy-volunteer study; not a dialysis clinical-outcome trial.
Journal Article / Randomized Controlled Trial / Clinical Trial, Phase I / Research Support, Non-U.S. Gov't