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

Not Applicable

Completed

• Conditions: Metabolic Bone Disease
• Interventions: Drug: Lanthanum Carbonate (Fosrenol); Drug: placebo

• Registration Number: NCT01002872
• Lead Sponsor: NorthShore University HealthSystem

Brief Summary

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

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Primary Completion: 2012-05
• Study Completion: 2012-12
• Results First Submitted: 2021-03-01
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Results First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lanthanum Carbonate (Fosrenol)	Lanthanum Carbonate (Fosrenol)	Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol)
Placebo	placebo	Subject will receive placebo

Primary Outcome Measures

Name	Time	Method
Fibroblast Growth Factor (FGF) 23 Mean Change From Baseline	Baseline, 60 days	Mean change from baseline of FGF23 in subjects treated with Lanthanum Carbonate verse placebo at 60 days

Secondary Outcome Measures

Name	Time	Method
25 Hydroxyvitamin D Mean Change From Baseline	Baseline, 60 days	Mean change from baseline 25 hydroxyvitamin D at 60 days
1,25 Dihydroxyvitamin D 3 Mean Change From Baseline	Baseline, 60 days	Mean change from baseline 1,25 dihydroxyvitamin D 3 at 60 days
Calcium Mean Change From Baseline	Baseline, 60 days	Mean change from baseline Calcium level at 60 days
Serum Phosphate Mean Change From Baseline	Baseline, 60 days	Mean change from baseline serum phosphate at 60 days
Serum Alkaline Phosphatase Mean Change From Baseline	Baseline, 60 days	Mean change from baseline serum alkaline phosphatase at 60 days
Serum Osteocalcin Mean Change From Baseline	Baseline, 60 days	Mean change from baseline serum osteocalcin at 60 days
Change From Baseline Serum Parathyroid Hormone	Baseline, 60 days	Change from baseline serum parathyroid hormone at 60 days
24 Hour Urine Phosphate Mean Change From Baseline	Baseline, 60 days	Mean change from baseline 24 hour urine phosphate at 60 days

Trial Locations

Locations (1)

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States