Overview

This trial is active, not recruiting.

Condition metabolic bone disease
Treatments lanthanum carbonate, fosrenol, placebo
Sponsor NorthShore University HealthSystem Research Institute
Collaborator Shire
Start date October 2009
End date May 2012
Trial size 20 participants
Trial identifier NCT01002872, EH 09-156

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Active Comparator)
lanthanum carbonate Fosrenol
Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill TID Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus <3.5mg/dL Reduce to 1 pill BID. If Phosphorus >5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is <3.5mg/dL Reduce to 1 pill daily. If phosphorus >5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus <3.5mg/dL stop the drug If phosphorus is >5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner
fosrenol Fosrenol
Initial dose of drug will be 1500mg TID
(Placebo Comparator)
placebo sugar pill
Initial dose of placebo will be 1 pill three times a day

Primary Outcomes

Measure
Assess the effects on Lanthanum Carbonate on c terminal and intact FGF 23 level
time frame: 60 days

Secondary Outcomes

Measure
Change from baseline serum calcium and albumin
time frame: 60 days
Change from baseline serum phosphate
time frame: 60 days
Change from baseline serum parathyroid hormone
time frame: 60 days
Change from baseline 1,25 dihydroxyvitamin D 3
time frame: 60 days
Change from baseline 25 hydroxyvitamin D
time frame: 60 days
Change from baseline serum alkaline phosphatase
time frame: 60 days
Change from baseline serum osteocalcin
time frame: 60 days
Change from baseline 24 hour urine, calcium,phosphorus, creatinine
time frame: 60 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 (FGF23 ) in Chronic Kidney Disease
Principal investigator Stuart M Sprague, DO
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by NorthShore University HealthSystem Research Institute.