The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease
Information source: NorthShore University HealthSystem Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Bone Disease
Intervention: Lanthanum Carbonate (Drug); Fosrenol (Drug); placebo (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: NorthShore University HealthSystem Research Institute Official(s) and/or principal investigator(s): Stuart M Sprague, DO, Principal Investigator, Affiliation: NorthShore University HealthSystem
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.
Clinical Details
Official title: The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 (FGF23 ) in Chronic Kidney Disease
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Assess the effects on Lanthanum Carbonate on c terminal and intact FGF 23 level
Secondary outcome: Change from baseline serum calcium and albuminChange from baseline serum phosphate Change from baseline serum parathyroid hormone Change from baseline 1,25 dihydroxyvitamin D 3 Change from baseline 25 hydroxyvitamin D Change from baseline serum alkaline phosphatase Change from baseline serum osteocalcin Change from baseline 24 hour urine, calcium,phosphorus, creatinine
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and non-pregnant females ages 18 years of age or older
- Estimated GFR between 15-60 ml/min/1. 73m
- Serum phosphate > 3. 5 mg/dL
- FGF2 > 100RU/mL
- Corrected serum clacium >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
Locations and Contacts
NorthShore University HealthSystem, Evanston, Illinois 60201, United States
Additional Information
Starting date: October 2009
Last updated: March 7, 2012
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