Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication LANTHANUM CARBONATE is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. FDA label
Also known as Lanthanum Carbonate (BAY77-1931)
Lanthanum Carbonate · 3 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | 750-2250mg/day, tid (three times a day), 8 weeks |
| Arm 2 | ACTIVE_COMPARATOR | 1500-4500mg/day, tid, 8 weeks |
| Name | Type | Description |
|---|---|---|
| Lanthanum carbonate (BAY77-1931) | DRUG | - |
| Calcium carbonate | DRUG | - |
Inclusion Criteria: * Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and \<11.0 mg/dL at 1 week after the initiation of the washout period. * Out-patient * Undergoing hemodialysis three times per week for at least previous 3 consecutive months Exclusion Criteria: * Pre-dialysis serum phosphate l...
Lanthanum Carbonate is used to treat hyperphosphatemia, a condition of elevated phosphate levels in the blood that commonly affects people with kidney disease, including those on dialysis. It is a small molecule therapy developed by Bayer AG and studied in nephrology, with clinical trials conducted in Japan.
Lanthanum Carbonate is developed by Bayer AG, which trades under the ticker BAYRY. Bayer conducted the clinical development program for the drug, including Phase 3 trials in Japan evaluating its use in patients with hyperphosphatemia, including those on peritoneal dialysis.
Lanthanum Carbonate has been studied in Phase 3 clinical development for hyperphosphatemia. Three trials are recorded, all completed, including two Phase 3 studies and one Phase 2 long-term bone concentration study. No trials are currently active.
Lanthanum Carbonate has been evaluated in three completed trials: NCT01518387, an open Phase 3 study in continuous ambulatory peritoneal dialysis patients; NCT01514851, a Phase 3 double-blind active-controlled comparison with calcium carbonate; and NCT00767637, a Phase 2 long-term study measuring lanthanum concentrations in bone.
Yes, Lanthanum Carbonate is also known by the development code BAY77-1931. Bayer AG used this code in trial titles such as the Phase 3 study of BAY77-1931 (Lanthanum Carbonate) in continuous ambulatory peritoneal dialysis patients and the Phase 3 comparison with calcium carbonate.