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Clinical trial

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

ID
Name
EH 09-156
Description
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.
Trial arms
Trial start
2009-10-01
Estimated PCD
2012-05-01
Trial end
2012-12-01
Status
Completed
Treatment
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
Arms:
Lanthanum Carbonate (Fosrenol)
Other names:
Fosrenol
placebo
Initial dose of placebo will be 1 pill three times a day
Arms:
Placebo
Other names:
sugar pill
Size
19
Primary endpoint
Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline
Baseline, 60 days
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}
Updated at
2023-09-21

1 organization

1 product

1 drug

1 indication

Organization
NorthShore University HealthSystem
Product
Lanthanum Carbonate
Indication
Metabolic Bone Disease
Drug
placebo