The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease
NCT ID: NCT01002872
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
19 participants
INTERVENTIONAL
2009-10-31
2012-12-31
Brief Summary
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Targeting FGF23 measurement in CKD patients may impact both the progression of kidney disease and patient mortality.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
Placebo
Subject will receive placebo
placebo
Initial dose of placebo will be 1 pill three times a day
Interventions
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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
placebo
Initial dose of placebo will be 1 pill three times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Estimated glomerular filtration rate (GFR) between 15-60 ml/min/1.73m
* Serum phosphate \> 3.5 mg/dL
* Fibroblast growth factor 2 (FGF2) \> 100 relative units per milliliter (RU/mL)
* Corrected serum calcium \>8.0mg/dL
Exclusion Criteria
* Corrected serum calcium \<8.0mg/dL
* Current use of prescription-based vitamin D therapy
* Acute kidney injury in last 3 months
* Significant GI disorder
* History of allergic reaction or sensitivity to lanthanum carbonate
* History of non compliance with visits or medications that preclude study compliance in the opinion of the investigator
* Pregnant or able to become pregnant and unwilling to use a birth control method considered reliable by the principal investigator
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Endeavor Health
OTHER
Responsible Party
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Stuart Sprague
Chief, Division of Nephrology and Hypertension Professor of Medicine University of Chicago Medical School
Principal Investigators
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Stuart M Sprague, DO
Role: PRINCIPAL_INVESTIGATOR
Endeavor Health
Locations
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NorthShore University HealthSystem
Evanston, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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EH 09-156
Identifier Type: -
Identifier Source: org_study_id
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