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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
Fosrenol · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Fosrenol (Lanthanum Carbonate, BAY77-1931) | DRUG | Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks. |
| Placebo | DRUG | daily dose: 3 tablets TID for 8 weeks. |
Inclusion Criteria: * Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study). Exclusion Criteria: * Pa...
Fosrenol is used to treat hyperphosphatemia, a condition of elevated phosphate levels in the blood, in patients with chronic kidney disease. It is a small molecule therapy in the nephrology area. Bayer AG developed it, and the clinical program includes Phase 3 studies conducted in Japan in patients with chronic kidney disease.
Fosrenol is developed by Bayer AG, which trades under the ticker BAYRY. Bayer conducted the Phase 3 clinical program for Fosrenol in hyperphosphatemia associated with chronic kidney disease, including two completed trials in Japan. The drug is also known by the code BAY77-1931.
Fosrenol has been studied in Phase 3 clinical development for hyperphosphatemia in chronic kidney disease. Two Phase 3 trials are recorded, both completed, with a combined enrollment of 266 patients. The studies were randomized, double-blind, and placebo-controlled, and were conducted in Japan.
Fosrenol has been evaluated in two completed Phase 3 trials. NCT01187628 was a long-term extension study in chronic kidney disease with 123 patients, and NCT01110629 studied chronic kidney disease patients not on dialysis with 143 patients. Both enrolled adults aged 20 years and older in Japan.
Yes, Fosrenol is the brand name for lanthanum carbonate, also identified by the development code BAY77-1931. It is a small molecule treatment developed by Bayer AG for hyperphosphatemia in patients with chronic kidney disease, studied in Phase 3 trials conducted in Japan.