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| Name | Class |
|---|---|
| Loma Linda University | OTHER |
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FGF-23 is a newly described protein that is an important regulator of phosphorus in the body. This protein increases in people with kidney disease and people who need dialysis have very high levels of FGF-23 in the blood. However, although some studies have indicated that FGF-23 levels go up with increased intake of phosphorus, no one knows if FGF-23 levels can be lowered in patients with kidney disease by preventing them from absorbing phosphorus from food. This study is designed to see what happens to levels of FGF-23 in the blood when patients with chronic kidney disease take medications to prevent phosphorus absorption. Since high levels of FGF-23 have been linked with increased rates of death in patients with advanced kidney disease, controlling the levels may, in the future, be a way to decrease heart disease in patients with kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renvela | Experimental | Daily renvela with meals for 12 weeks |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevelamer Carbonate | Drug | Daily renvela (800 mg tid with meals) x 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in FGF-23 Level | Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 1,25(OH)2vitamin D Value | Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks. | 12 week |
| Serum Phosphate Concentration | Change in serum phosphate at 12 weeks from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Renvela | Sevelamer Carbonate (Renvela) 800 mg tablets: 1 tablet TID with meals for 12 weeks |
| FG001 | Placebo | Placebo (inert tablets): 1 tablet TID with meals for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Renvela | Daily renvela with meals for 12 weeks Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks |
| BG001 | Placebo | Placebo: 1 inert tablet tid x 12 weeks |
| 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 |
| 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 in FGF-23 Level | Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo. | Posted | Mean | Standard Deviation | percentage change from baseline | 12 weeks |
|
|
3 months
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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 | Renvela | Daily renvela with meals for 12 weeks Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Wesseling-Perry | University of California at Los Angeles | 310-206-6987 | kwesseling@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069603 | Sevelamer |
| ID | Term |
|---|---|
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Other | 1 inert tablet tid x 12 weeks |
|
| 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | 1,25(OH)2vitamin D Value | Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks. | Posted | Mean | Standard Deviation | percent change from baseline | 12 week |
|
|
|
| Secondary | Serum Phosphate Concentration | Change in serum phosphate at 12 weeks from baseline | Posted | Mean | Standard Deviation | percent change from baseline | 12 weeks |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Placebo | Placebo: 1 inert tablet tid x 12 weeks | 0 | 9 | 0 | 9 | 0 | 9 |
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