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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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The purpose of this study is to learn more about how the kidneys control the blood levels of phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.
Phosphorus is a mineral found in dairy products, nuts, and meat that is essential for bone health and many other important functions inside the body's cells. The kidneys are responsible for keeping the blood levels of phosphorus normal. Healthy kidneys do this by spilling excess phosphorus into the urine. In patients with chronic kidney disease, the kidneys are unable to spill an adequate amount of phosphorus so that excess phosphorus can accumulate in the walls of blood vessels leading to heart disease, their leading cause of death. A recently discovered hormone called FGF-23 helps control the blood levels of phosphorus by "telling" the kidney how much phosphorus to spill in the urine. The purpose of this study is to learn more about how FGF-23 helps the kidneys control the blood levels of phosphorus. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanthanum Carbonate and Low Phosphorus Diet | Active Comparator | 25% of subjects will receive binders plus a phosphate restricted diet. |
|
| Lanthanum Carbonate and Unrestricted Phosphorus Diet | Active Comparator | 25% binders + unrestricted phosphate diet. |
|
| Placebo and Low Phosphorus Diet | Active Comparator | 25% placebo + phosphate restricted diet. |
|
| Placebo and Unrestricted Phosphorus Diet | Active Comparator | 25% placebo + unrestricted phosphate diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum Carbonate | Drug | Lanthanum carbonate 1000mg 3x/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fibroblast Growth Factor 23 (FGF-23) | Plasma FGF-23 was measured using c-terminal FGF23 assay. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Urinary Phosphate | from 24-hr urine collections | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myles Wolf, MD, MMSc | Univesity of Miami Miller School of Medicine | Principal Investigator |
| Harald Jueppner, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20631407 | Result | Isakova T, Gutierrez OM, Smith K, Epstein M, Keating LK, Juppner H, Wolf M. Pilot study of dietary phosphorus restriction and phosphorus binders to target fibroblast growth factor 23 in patients with chronic kidney disease. Nephrol Dial Transplant. 2011 Feb;26(2):584-91. doi: 10.1093/ndt/gfq419. Epub 2010 Jul 14. |
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There was no wash-out, run in or transition.
16 patients completed the full study. Patients were recruited from renal clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lanthanum Carbonate & Low Phosphorous Diet | Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day. |
| FG001 | Lanthanum Carbonate & Unrestricted Phosphorous Diet | Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. |
| FG002 | Placebo & Low Phosphorous Diet | Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day. |
| FG003 | Placebo & Unrestricted Phosphorous Diet | Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lanthanum Carbonate & Low Phosphorous Diet | Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day. |
| BG001 | Lanthanum Carbonate & Unrestricted Phosphorous Diet |
| 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 | Fibroblast Growth Factor 23 (FGF-23) | Plasma FGF-23 was measured using c-terminal FGF23 assay. | Posted | Mean | Standard Error | RU/ml | 2 weeks |
|
2 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 & Low Phosphorous Diet | Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day. |
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In addition to limited power, the small sample size led to imbalances in baseline laboratory tests, which added further variability to the analyses. .
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tamara Isakova, MD, MMSc | University of Miami Miller School of Medicine | 305-243-4374 | tisakova@med.miami.edu |
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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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| Low Phosphorus Diet | Dietary Supplement | Low phosphorus diet will consist of 800 mg of phosphorus per day. |
|
| Unrestricted Phosphorus Diet | Dietary Supplement | Unrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. |
|
|
| Placebo | Drug | Lanthanum Carbonate placebo given three times a day with meals. |
|
Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
| BG002 | Placebo & Low Phosphorous Diet | Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day. |
| BG003 | Placebo & Unrestricted Phosphorous Diet | Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. |
| BG004 | 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 |
|
| Fibroblast Growth Factor 23 (FGF-23) | Plasma FGF-23 at the baseline visit was measured using C-terminal FGF23 assay. | Mean | Standard Deviation | Ru/ml |
|
| 24-hr urine phosphate | measured from 24 hour urine collections; 2 separate collections were obtained; values are means of the two collections; pre-intervention | Mean | Standard Deviation | mg |
|
| Placebo & Low Phosphorous Diet |
Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day. |
| OG003 | Placebo & Unrestricted Phosphorous Diet | Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. |
|
|
| Secondary | 24-hour Urinary Phosphate | from 24-hr urine collections | Posted | Mean | Standard Error | mg | 2 weeks |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Lanthanum Carbonate & Unrestricted Phosphorous Diet | Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. | 0 | 4 | 0 | 4 |
| EG002 | Placebo & Low Phosphorous Diet | Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day. | 0 | 4 | 0 | 4 |
| EG003 | Placebo & Unrestricted Phosphorous Diet | Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. | 0 | 4 | 0 | 4 |
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| 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 |