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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
Also known as SPD405, Fosrenol
Lanthanum Carbonate · 9 trials · 5 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 |
|---|---|---|
| 1 | EXPERIMENTAL | Fosrenol (Lanthanum carbonate) |
| 2 | ACTIVE_COMPARATOR | Sevelamer hydrochloride |
| 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 | - |
| Meal + Lanthanum | EXPERIMENTAL | - |
| Meal + Sevelamer | ACTIVE_COMPARATOR | - |
| Meal Only | NO_INTERVENTION | - |
| Fasting | NO_INTERVENTION | - |
| Name | Type | Description |
|---|---|---|
| Fosrenol (Lanthanum Carbonate) | DRUG | The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets. |
| Sevelamer hydrochloride | DRUG | The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals. |
| 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: * Adults with end stage renal disease who are receiving dialysis Exclusion Criteria: * Subjects with significant gastrointestinal disorders * Subjects who are pregnant or nursing * Subjects currently taking lanthanum carbonate, sevelamer hydrochloride, cinacalcet hydrochloride...
Lanthanum Carbonate is used to treat hyperphosphatemia, or elevated serum phosphorus, in people with chronic kidney disease, including kidney failure and dialysis patients. Clinical trials have studied it in adults with stage 3 and 4 CKD and in children and adolescents with CKD on dialysis.
Lanthanum Carbonate is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical trials evaluating the drug in chronic kidney disease and related kidney conditions.
Lanthanum Carbonate is in Phase 2 clinical development. Five trials have been completed, including Phase 1 and Phase 2 studies, with no active trials currently listed. The completed studies enrolled a total of 1,088 participants.
Lanthanum Carbonate has been studied in completed trials including NCT01696279 in hyperphosphatemic children and adolescents with CKD on dialysis, NCT01128179 on FGF-23 effects in stage 3 CKD, NCT00875017 comparing phosphorus absorption in healthy volunteers, and NCT00234702 in stage 3 and 4 CKD.