Status:
COMPLETED
The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease
Lead Sponsor:
Endeavor Health
Collaborating Sponsors:
Shire
Conditions:
Metabolic Bone Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 FGF...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01002872
Start Date
October 1 2009
End Date
December 1 2012
Last Update
September 21 2023
Active Locations (1)
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1
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201