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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-004959-38 | EudraCT Number |
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To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fosrenol (Lanthanum carbonate) |
|
| 2 | Active Comparator | Sevelamer hydrochloride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Phosphorus Levels at 4 Weeks | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Calcium Levels at 4 Weeks | 4 weeks | |
| Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks | Baseline and 4 weeks | |
| Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 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 |
|---|---|---|---|---|---|---|
| DSI Renal Inc. | Mesa | Arizona | 85202 | United States | ||
| AKDHC Medical Research Services, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19825330 | Background | Sprague SM, Ross EA, Nath SD, Zhang P, Pratt RD, Krause R. Lanthanum carbonate vs. sevelamer hydrochloride for the reduction of serum phosphorus in hemodialysis patients: a crossover study. Clin Nephrol. 2009 Oct;72(4):252-8. doi: 10.5414/cnp72252. | |
| 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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The study consisted of the following phases: screening (1 week), washout 1 (2 weeks), treatment (4 weeks), Washout 2 (2 weeks), crossover treatment (4 weeks), and a 30-day follow-up
Following Washout 1, eligible subjects with serum phosphorus levels greater than or equal to 6.0mg/dL (greater than or equal to 1.94mmol/L) and calcium levels greater than or equal to 8.4mg/dL (greater than or equal to 2.10mmol/L) were randomized in a 1:1 ratio to receive either Fosrenol or sevelamer hydrochloride (HCl) for 4 weeks.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fosrenol First | Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
|
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|
| 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. |
|
Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L) |
| 4 weeks |
| Phoenix |
| Arizona |
| 85012 |
| United States |
| Southwest Kidney Institute, PLC | Tempe | Arizona | 85284 | United States |
| Tempe | Arizona | 85284 | United States |
| University of Arizona Health Service Center | Tucson | Arizona | 85724 | United States |
| Clinical Research Connections | Jonesboro | Arkansas | 72401 | United States |
| South Valley Dialysis Center | Encino | California | 91316 | United States |
| VA Greater Los Angeles Health Care System, West LA | Los Angeles | California | 90073 | United States |
| Apex Research of Riverside | Riverside | California | 92505 | United States |
| North Valley Nephrology | Yuba City | California | 95991 | United States |
| Western Nephrology & Metabolic Bone Disease, PC | Thornton | Colorado | 80260 | United States |
| Shands University of Florida Outpatient Dialysis | Gainesville | Florida | 32608 | United States |
| Discovery Medical Research Group | Ocala | Florida | 34471 | United States |
| Pines Clinical Research | Pembroke Pines | Florida | 33028 | United States |
| Clinical Research Center of Indian River Medical Center | Vero Beach | Florida | United States |
| Kidney Care Associates, LLC | Augusta | Georgia | 30901 | United States |
| Renal Physicians of Georgia | Macon | Georgia | 31217 | United States |
| Evanston Northwestern Hospital | Evanston | Illinois | 60201 | United States |
| Research by Design, LLC | Evergreen Park | Illinois | 60805 | United States |
| Nephrology Inc. | Mishawaka | Indiana | 46545 | United States |
| Renal Associates of Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131 | United States |
| Hypertension and Nephrology, Associates | Eatontown | New Jersey | 07724 | United States |
| Winthrop Dialysis Center | Mineola | New York | 11501 | United States |
| SUNY at Stony Brook NY | Stony Brook | New York | 11794 | United States |
| Wake Nephrology Associates | Raleigh | North Carolina | 27609 | United States |
| Southeastern Nephrology Associates | Wilmington | North Carolina | 28401 | United States |
| Northwest Renal Clinic | Portland | Oregon | 97210 | United States |
| Carolina Nephrology, PA | Greenville | South Carolina | 29605 | United States |
| VA Tennessee Valley Healthcare System | Nashville | Tennessee | 37212 | United States |
| Rosa Verde Tower | San Antonio | Texas | 78205 | United States |
| University of Texas Health Science Center at San Antonio Medicine/Nephrology | San Antonio | Texas | 78229 | United States |
| Alexandria Kidney | Alexandria | Virginia | 22304 | United States |
| Clinical Research & Consulting Center, LLC | Fairfax | Virginia | 22030 | United States |
| KfH Nierenzentrum/Bad/Konig | Bad König | 64732 | Germany |
| KfH Nierenzentrum | Berlin | 10559 | Germany |
| KfH Dialysezentrum/Berlin | Berlin | 12045 | Germany |
| KfH Nierenzentrum/Dulmen | Dülmen | 48249 | Germany |
| Georg-August-Universitat Universitatsmedizin Abt. Nephrologie u. Rheumatologie | Göttingen | 37075 | Germany |
| Dialysezentrum Barmbeck | Hamburg | 22297 | Germany |
| KfH-Nierenzentrum/Jena | Jena | 07751 | Germany |
| KfH-Dialysezentrum/Rosenheim | Rosenheim | 83022 | Germany |
| Jose Cangiano, MD | San Juan | 00918 | Puerto Rico |
| Churchill Hospital Oxford Kidney Unit | Oxford | OX3 7LJ | United Kingdom |
| FG001 | Sevelamer HCl First | Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Washout |
|
| Second Intervention |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Change From Baseline in Serum Phosphorus Levels at 4 Weeks | ITT population defined as subjects who were randomized, received at least one dose of investigational product, and had at least one post-dose assessment of the primary efficacy variable. | Posted | Least Squares Mean | Standard Error | mg/dL | 4 weeks |
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| Secondary | Change From Baseline in Serum Calcium Levels at 4 Weeks | ITT | Posted | Least Squares Mean | Standard Error | mg/dL | 4 weeks |
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| Secondary | Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks | ITT | Posted | Mean | Standard Error | pg/mL | Baseline and 4 weeks |
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| Secondary | Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks | Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L) | Posted | Number | Percentage of Participants | 4 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 | Fosrenol | Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below). | 18 | 170 | 31 | 170 | ||
| EG001 | Sevelamer HCl | Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above). | 20 | 163 | 27 | 163 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Vascular disorders | Non-systematic Assessment |
| ||
| Congestive heart failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Clostridium difficile colitis | Infections and infestations | Non-systematic Assessment |
| ||
| Presyncope | Nervous system disorders | Non-systematic Assessment |
| ||
| Foot infection | Infections and infestations | Non-systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Weakness | General disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Coronary atery disease | Cardiac disorders | Non-systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Extremity necrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cystitis | Infections and infestations | Non-systematic Assessment |
| ||
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Septic phlebitis | Infections and infestations | Non-systematic Assessment |
| ||
| Stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Unstable angina | Cardiac disorders | Non-systematic Assessment |
| ||
| Cerebral vascular accident | Nervous system disorders | Non-systematic Assessment |
| ||
| Pripheral neuropathy | Nervous system disorders | Non-systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Withdrawal by Subject |
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| Kidney Transplant |
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| Lack of Efficacy |
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| Subject exceeded safety criteria |
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| Subject moved |
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| Germany |
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| United Kingdom |
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