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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
19
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
Initial dose of placebo will be 1 pill three times a day
NorthShore University HealthSystem
Evanston, Illinois, United States
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
Time frame: Baseline, 60 days
Calcium Mean Change From Baseline
Mean change from baseline Calcium level at 60 days
Time frame: Baseline, 60 days
Serum Phosphate Mean Change From Baseline
Mean change from baseline serum phosphate at 60 days
Time frame: Baseline, 60 days
Change From Baseline Serum Parathyroid Hormone
Change from baseline serum parathyroid hormone at 60 days
Time frame: Baseline, 60 days
1,25 Dihydroxyvitamin D 3 Mean Change From Baseline
Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days
Time frame: Baseline, 60 days
25 Hydroxyvitamin D Mean Change From Baseline
Mean change from baseline 25 hydroxyvitamin D at 60 days
Time frame: Baseline, 60 days
Serum Alkaline Phosphatase Mean Change From Baseline
Mean change from baseline serum alkaline phosphatase at 60 days
Time frame: Baseline, 60 days
Serum Osteocalcin Mean Change From Baseline
Mean change from baseline serum osteocalcin at 60 days
Time frame: Baseline, 60 days
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24 Hour Urine Phosphate Mean Change From Baseline
Mean change from baseline 24 hour urine phosphate at 60 days
Time frame: Baseline, 60 days