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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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The aim of the study is to assess the effects of the drug lanthanum carbonate (a phosphorus binder drug) on c-terminal and on FGF23 levels in patients with Chronic Kidney Disease (CKD).
Targeting FGF23 measurement in CKD patients may impact both the progression of kidney disease and patient mortality.
This is a double blind randomized placebo controlled pilot study. Subjects with Chronic Kidney Disease ( CKD) stages 3-5 who are not undergoing renal replacement therapy and have not been started on phosphate binders will be randomized to either lanthanum carbonate 1500 mg daily or placebo for a 60 day treatment period. Patient doses will be increased up to a maximum dose of 3000 mg if the serum phosphate is greater than 5.5 mg/dL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanthanum Carbonate (Fosrenol) | Active Comparator | Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) |
|
| Placebo | Placebo Comparator | Subject will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum Carbonate (Fosrenol) | Drug | Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill three times a day (TID) Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus <3.5mg/dL Reduce to 1 pill twice a day (BID). If Phosphorus >5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is <3.5mg/dL Reduce to 1 pill daily. If phosphorus >5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus <3.5mg/dL stop the drug If phosphorus is >5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner |
| Measure | Description | Time Frame |
|---|---|---|
| Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline | Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days | Baseline, 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Calcium Mean Change From Baseline | Mean change from baseline Calcium level at 60 days | Baseline, 60 days |
| Serum Phosphate Mean Change From Baseline | Mean change from baseline serum phosphate at 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart M Sprague, DO | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19534362 | Background | Stubbs JR, Quarles LD. Fibroblast growth factor 23: uremic toxin or innocent bystander in chronic kidney disease? Nephrol News Issues. 2009 May;23(6):33-4, 36-7. | |
| 19339809 | Background | Saji F, Shiizaki K, Shimada S, Okada T, Kunimoto K, Sakaguchi T, Hatamura I, Shigematsu T. Regulation of fibroblast growth factor 23 production in bone in uremic rats. Nephron Physiol. 2009;111(4):p59-66. doi: 10.1159/000210389. Epub 2009 Apr 1. |
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Data will be compiled into a manuscript
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Subjects who were naive to phosphate binders were enrolled
The date of recruitment 10/27/09-3/7/12.The subjects were seen at Evanston and Glenbrook outpatient clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Lanthanum Carbonate (Fosrenol) | Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill three times a day (TID) Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus <3.5mg/dL Reduce to 1 pill twice a day (BID). If Phosphorus >5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is <3.5mg/dL Reduce to 1 pill daily. If phosphorus >5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus <3.5mg/dL stop the drug If phosphorus is >5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner |
| FG001 | Placebo | Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lanthanum Carbonate (Fosrenol) | Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus <3.5mg/dL Reduce to 1 pill BID. If Phosphorus >5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is <3.5mg/dL Reduce to 1 pill daily. If phosphorus >5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus <3.5mg/dL stop the drug If phosphorus is >5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner |
| 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 (FGF) 23 Mean Change From Baseline | Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days | Only patients with readings at both timepoints (baseline and 60 days) were included. | Posted | Mean | Standard Deviation | RU/mL | Baseline, 60 days |
|
60 days
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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 (Fosrenol) | Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) Lanthanum Carbonate (Fosrenol): Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus <3.5mg/dL Reduce to 1 pill BID. If Phosphorus >5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is <3.5mg/dL Reduce to 1 pill daily. If phosphorus >5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus <3.5mg/dL stop the drug If phosphorus is >5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild | General disorders | broken tooth | Systematic Assessment | Broken tooth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Stuart Sprague | Northshore University Healthsystem | 847-570-1761 | ssprague@northshore.org |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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|
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| placebo | Drug | Initial dose of placebo will be 1 pill three times a day |
|
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| Baseline, 60 days |
| Change From Baseline Serum Parathyroid Hormone | Change from baseline serum parathyroid hormone at 60 days | Baseline, 60 days |
| 1,25 Dihydroxyvitamin D 3 Mean Change From Baseline | Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days | Baseline, 60 days |
| 25 Hydroxyvitamin D Mean Change From Baseline | Mean change from baseline 25 hydroxyvitamin D at 60 days | Baseline, 60 days |
| Serum Alkaline Phosphatase Mean Change From Baseline | Mean change from baseline serum alkaline phosphatase at 60 days | Baseline, 60 days |
| Serum Osteocalcin Mean Change From Baseline | Mean change from baseline serum osteocalcin at 60 days | Baseline, 60 days |
| 24 Hour Urine Phosphate Mean Change From Baseline | Mean change from baseline 24 hour urine phosphate at 60 days | Baseline, 60 days |
| 18839328 | Background | Ibrahim S, Rashed L. Serum fibroblast growth factor-23 levels in chronic haemodialysis patients. Int Urol Nephrol. 2009;41(1):163-9. doi: 10.1007/s11255-008-9466-0. Epub 2008 Oct 7. |
| 18800026 | Background | Moe SM, Chen NX, Seifert MF, Sinders RM, Duan D, Chen X, Liang Y, Radcliff JS, White KE, Gattone VH 2nd. A rat model of chronic kidney disease-mineral bone disorder. Kidney Int. 2009 Jan;75(2):176-84. doi: 10.1038/ki.2008.456. Epub 2008 Sep 17. |
| 17656479 | Background | Fliser D, Kollerits B, Neyer U, Ankerst DP, Lhotta K, Lingenhel A, Ritz E, Kronenberg F; MMKD Study Group; Kuen E, Konig P, Kraatz G, Mann JF, Muller GA, Kohler H, Riegler P. Fibroblast growth factor 23 (FGF23) predicts progression of chronic kidney disease: the Mild to Moderate Kidney Disease (MMKD) Study. J Am Soc Nephrol. 2007 Sep;18(9):2600-8. doi: 10.1681/ASN.2006080936. Epub 2007 Jul 26. |
| 16932898 | Background | Fukagawa M, Kazama JJ. FGF23: its role in renal bone disease. Pediatr Nephrol. 2006 Dec;21(12):1802-6. doi: 10.1007/s00467-006-0230-3. Epub 2006 Aug 24. |
| BG001 | Placebo | Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day |
|
|
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| Secondary | Calcium Mean Change From Baseline | Mean change from baseline Calcium level at 60 days | Only patients with readings at both timepoints (baseline and 60 days) were included. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 60 days |
|
|
|
|
| Secondary | Serum Phosphate Mean Change From Baseline | Mean change from baseline serum phosphate at 60 days | Only patients with readings at both timepoints (baseline and 60 days) were included. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 60 days |
|
|
|
|
| Secondary | Change From Baseline Serum Parathyroid Hormone | Change from baseline serum parathyroid hormone at 60 days | Only patients with readings at both timepoints (baseline and 60 days) were included. | Posted | Mean | Standard Deviation | percent change in PTH | Baseline, 60 days |
|
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|
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| Secondary | 1,25 Dihydroxyvitamin D 3 Mean Change From Baseline | Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days | Only patients with readings at both timepoints (baseline and 60 days) were included. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 60 days |
|
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| Secondary | 25 Hydroxyvitamin D Mean Change From Baseline | Mean change from baseline 25 hydroxyvitamin D at 60 days | Only patients with readings at both timepoints (baseline and 60 days) were included. | Posted | Mean | Standard Deviation | ng/mL | Baseline, 60 days |
|
|
|
|
| Secondary | Serum Alkaline Phosphatase Mean Change From Baseline | Mean change from baseline serum alkaline phosphatase at 60 days | Only patients with readings at both timepoints (baseline and 60 days) were included. | Posted | Mean | Standard Deviation | U/L | Baseline, 60 days |
|
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| Secondary | Serum Osteocalcin Mean Change From Baseline | Mean change from baseline serum osteocalcin at 60 days | Osteocalcin concentrations were not measured | Posted | Baseline, 60 days |
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| Secondary | 24 Hour Urine Phosphate Mean Change From Baseline | Mean change from baseline 24 hour urine phosphate at 60 days | Only patients with readings at both timepoints (baseline and 60 days) were included. | Posted | Mean | Standard Deviation | mg | Baseline, 60 days |
|
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Placebo | Subject will receive placebo placebo: Initial dose of placebo will be 1 pill three times a day | 0 | 9 | 0 | 9 | 0 | 9 |
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| D010760 | Phosphorus Metabolism Disorders |