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Lanthanum Carbonate · 8 trials · 4 indications
KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (\>=) 12 to less than (\<) 18 years to be less than or equal to (\<=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter \[mmol/L\]); Children aged \>=10 years to \<12 years to be \<= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level was reported only for the participants who had received lanthanum carbonate during part 2 or part 3. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
FGF-23 plays an important role in mineral metabolism in chronic kidney disease patients. It is secreted by bone cells in response to hyperphosphatemia. It acts to decrease renal phosphate reabsorption. Administration of a phosphate-binder (i.e. lanthanum carbonate) was expected to produce a reduction in FGF-23 levels.
Net phosphorous absorption (Lanthanum carbonate period) = phosphorous ingested in meal minus (Rectal effluent phosphorous after Lanthanum carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Sevelamer Carbonate period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after Sevelamer carbonate + meal minus Rectal effluent phosphorous after fasting). Net phosphorous absorption (Meal only period) = Phosphorous ingested in meal minus (Rectal effluent phosphorous after meal only minus Rectal effluent phosphorous after fasting).
| Arm | Type | Description |
|---|---|---|
| Lanthanum Carbonate | EXPERIMENTAL | Participants will receive lanthanum carbonate orally at a total daily dose of 1500 mg to 3000 mg divided and mixed equally between in three meals. |
| Calcium Carbonate | ACTIVE_COMPARATOR | Participants will receive calcium carbonate orally at a total daily dose adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached. |
| Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| Meal + Lanthanum | EXPERIMENTAL | - |
| Meal + Sevelamer | ACTIVE_COMPARATOR | - |
| Meal Only | NO_INTERVENTION | - |
| Fasting | NO_INTERVENTION | - |
| Name | Type | Description |
|---|---|---|
| Lanthanum carbonate | DRUG | - |
| Calcium Carbonate | DRUG | Calcium carbonate will be administered orally at a total daily dose based on standard clinical practice. The total daily dose may be adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached. |
| Placebo | DRUG | Matching placebo chewable tablets administered 3 times a day for 12 weeks |
| Sevelamer | DRUG | 3 x 800mg tablets |
Inclusion Criteria: * Patients receiving haemodialysis for ESRD * Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months Exclusion Criteria: * Pregnant or lactating women * Patients with clinically significant uncontrolled concu...
Lanthanum Carbonate is a small molecule being developed by Takeda Pharmaceutical Company Limited for kidney diseases, including chronic kidney disease and chronic kidney failure. It is being studied for its ability to reduce serum phosphorus levels in patients with stage 3 and 4 chronic kidney disease and for hyperphosphatemia in children and adolescents on dialysis.
Lanthanum Carbonate is a phosphate binder. It works by binding to dietary phosphorus in the gastrointestinal tract, reducing its absorption into the bloodstream. This mechanism helps lower serum phosphorus levels in patients with chronic kidney disease, where phosphorus excretion is impaired.
Lanthanum Carbonate is developed by Takeda Pharmaceutical Company Limited, a company listed on the stock exchange under the ticker TAK. Takeda is conducting clinical trials to evaluate the drug's efficacy and safety in patients with chronic kidney disease and related conditions.
Lanthanum Carbonate is in Phase 3 clinical development for chronic kidney disease and chronic kidney failure. It is an investigational drug and has not been approved by regulatory authorities. The drug has completed five clinical trials, including Phase 1 and Phase 2 studies, with a total enrollment of 1,088 participants.
Lanthanum Carbonate has been studied in several completed clinical trials, including NCT00234702, a Phase 2 study in patients with stage 3 and 4 chronic kidney disease, and NCT01696279, a Phase 2 study in hyperphosphatemic children and adolescents with chronic kidney disease on dialysis. Other trials include NCT00875017 and NCT01128179.
Lanthanum Carbonate is the active ingredient in the brand-name product FOSRENOL. In clinical trials, FOSRENOL is used as the study drug to compare the absorption of dietary phosphorus with another phosphate binder, RENVELA. This comparison helps evaluate the efficacy of lanthanum carbonate in managing phosphorus levels.