The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 (FGF23 ) in Chronic Kidney Disease

Conditions
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Metabolic Bone Disease

Intervention / Treatment
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* Drug: Lanthanum Carbonate (Fosrenol)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and non-pregnant females ages 18 years of age or older 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: Current use of a phosphate binder 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lanthanum Carbonate (Fosrenol)<br>Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) | Drug: Lanthanum Carbonate (Fosrenol)<br>* 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<br>* Other names: Fosrenol;|
| Placebo Comparator: Placebo<br>Subject will receive placebo | Drug: placebo<br>* Initial dose of placebo will be 1 pill three times a day<br>* Other names: sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FGF23, CKD, Fosrenol, Hyperphosphatemia