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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 albumin

Change 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

Page last updated: August 23, 2015

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