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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016531-35 | EudraCT Number |
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To assess the effects of 12 weeks of treatment with lanthanum carbonate compared with placebo on serum intact Fibroblast Growth Factor 23 (FGF23) levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanthanum carbonate | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum carbonate | Drug | 1000 mg in chewable tablets administered three times a day (for a total of 3000 mg/day) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF) | 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. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF) | 12 Weeks | |
| Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF) | 12 weeks | |
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Inclusion Criteria:
Subjects meeting all of the criteria listed below may be included in the study:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Pablo Urena Torres | Saint-Ouen | Paris | 93400 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24885942 | Result | Urena-Torres P, Prie D, Keddad K, Preston P, Wilde P, Wan H, Copley JB. Changes in fibroblast growth factor 23 levels in normophosphatemic patients with chronic kidney disease stage 3 treated with lanthanum carbonate: results of the PREFECT study, a phase 2a, double blind, randomized, placebo-controlled trial. BMC Nephrol. 2014 May 5;15:71. doi: 10.1186/1471-2369-15-71. | |
| 40576086 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lanthanum Carbonate | 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks |
| FG001 | Placebo | Matching placebo chewable tablets administered 3 times a day for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Safety Analysis Set was defined as all randomized subjects who received at least 1 dose of investigational product. This population was used in all safety reporting.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lanthanum Carbonate | 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks |
| BG001 | Placebo | Matching placebo chewable tablets administered 3 times a day for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Natural Logarithm Transformed Serum Intact Fibroblast Growth Factor (FGF-23) Levels at Week 12 Last Observation Carried Forward (LOCF) | 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. | Per-protocol (PP) set are subjects who received at least 1 dose of investigational product and who had primary data assessment available from Week 2 or later and who did not have pre-defined major protocol deviations that could have affected the primary variable. | Posted | Least Squares Mean | Standard Error | pg/ml | 12 Weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lanthanum Carbonate | 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
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| Placebo | Drug | Matching placebo chewable tablets administered 3 times a day for 12 weeks |
|
| Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF) |
| 12 weeks |
| Change From Baseline in Serum Phosphate Values at Week 12 (LOCF) | 12 weeks |
| Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF) | 12 weeks |
| Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF) | 12 weeks |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo | Matching placebo chewable tablets administered 3 times a day for 12 weeks |
|
|
|
| Secondary | Change From Baseline in Serum Intact Parathyroid Hormone (iPTH) Values at Week 12 (LOCF) | PP | Posted | Least Squares Mean | Standard Error | pg/ml | 12 Weeks |
|
|
|
|
| Secondary | Change From Baseline in 1,25-Dihydroxy Vitamin D Values at Week 12 (LOCF) | PP | Posted | Least Squares Mean | Standard Error | pg/ml | 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Urinary Fractional Excretion of Phosphate Values at Week 12 (LOCF) | PP | Posted | Least Squares Mean | Standard Error | percentage of excretion of phosphate | 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Serum Phosphate Values at Week 12 (LOCF) | PP | Posted | Least Squares Mean | Standard Error | mmol/L | 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Serum Total Calcium Values at Week 12 (LOCF) | PP | Posted | Least Squares Mean | Standard Error | mmol/L | 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Calcium-Phosphate Product Values at Week 12 (LOCF) | PP | Posted | Least Squares Mean | Standard Error | mmol^2/L^2 | 12 weeks |
|
|
|
|
| 2 |
| 23 |
| 2 |
| 23 |
| EG001 | Placebo | Matching placebo chewable tablets administered 3 times a day for 12 weeks | 0 | 12 | 0 | 12 |
| Myocardial ischemia | Cardiac disorders |
|
| Pancreatitis acute | Gastrointestinal disorders |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |