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Chronic kidney disease (CKD) can result in a loss of ability to filter and excrete phosphate. The body's attempt to adjust to an increased level of phosphate in the blood can result in elevated levels of hormones and minerals resulting in serious clinical consequences. This study is being conducted to evaluate the safety and efficacy of lanthanum carbonate in lowering high levels of phosphorus in the blood in subjects with CKD Stages 3 and 4 compared to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum carbonate | Drug | Lanthanum carbonate 750mg/day, T.I.D. for 2 weeks; titrated at the next 3 weekly visits in order to achieve target serum phosphorus levels, up to a maximum dose of 3000mg/day; 4-week maintenance period where subject receives the final titrated daily dose established during the titration period. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum phosphorus levels at 8 weeks. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PTH levels, calcium-phosphorus product. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Health Care System | Los Angeles | California | 90073 | United States | ||
| Barnett Research & Communications Medical Corporation |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19056618 | Result | Sprague SM, Abboud H, Qiu P, Dauphin M, Zhang P, Finn W. Lanthanum carbonate reduces phosphorus burden in patients with CKD stages 3 and 4: a randomized trial. Clin J Am Soc Nephrol. 2009 Jan;4(1):178-85. doi: 10.2215/CJN.02830608. Epub 2008 Dec 3. | |
| 40576086 | Derived | Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4. |
| Label | URL |
|---|---|
| FDA Recall Information | View source |
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|
|
| Placebo | Drug | Placebo |
|
| Torrance |
| California |
| 90503 |
| United States |
| Western Nephrology & Metabolic Bone Disease, PC | Thornton | Colorado | 80260 | United States |
| Outcomes Research International, Inc. | Hudson | Florida | 34667 | United States |
| Twin Cities Clinical Research | Brooklyn Center | Minnesota | 55430 | United States |
| St. Louis University/Nephrology | St Louis | Missouri | 63110 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Northwest Renal Clinic | Portland | Oregon | 97210 | United States |
| Nephrology Associates | Nashville | Tennessee | United States |
| Kidney Associates | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
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