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

NorthShore University HealthSystem

Status: Completed

Conditions: Metabolic Bone Disease

Treatments: Drug: placebo; Drug: Lanthanum Carbonate (Fosrenol)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01002872

EH 09-156

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 2 patient groups, including a placebo group

Lanthanum Carbonate (Fosrenol)

Active Comparator group

Description:

Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol)

Treatment:

Drug: Lanthanum Carbonate (Fosrenol)

Placebo

Placebo Comparator group

Description:

Subject will receive placebo

Treatment:

Drug: placebo