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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Shire Development LLC
Information provided by (Responsible Party):
Stuart M Sprague, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT01002872
First received: October 27, 2009
Last updated: March 7, 2012
Last verified: March 2012
History of Changes

October 27, 2009
March 7, 2012
October 2009
May 2012   (final data collection date for primary outcome measure)
Assess the effects on Lanthanum Carbonate on c terminal and intact FGF 23 level [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01002872 on ClinicalTrials.gov Archive Site
  • Change from baseline serum calcium and albumin [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Change from baseline serum phosphate [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Change from baseline serum parathyroid hormone [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Change from baseline 1,25 dihydroxyvitamin D 3 [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Change from baseline 25 hydroxyvitamin D [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Change from baseline serum alkaline phosphatase [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Change from baseline serum osteocalcin [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Change from baseline 24 hour urine, calcium,phosphorus, creatinine [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 ( FGF23) in Chronic Kidney Disease
The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 (FGF23 ) in Chronic Kidney Disease

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Metabolic Bone Disease
  • Drug: Lanthanum Carbonate
    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
    Other Name: Fosrenol
  • Drug: Fosrenol
    Initial dose of drug will be 1500mg TID
    Other Name: Fosrenol
  • Drug: placebo
    Initial dose of placebo will be 1 pill three times a day
    Other Name: sugar pill
  • Active Comparator: Lanthanum Carbonate
    Interventions:
    • Drug: Lanthanum Carbonate
    • Drug: Fosrenol
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
December 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01002872
EH 09-156
No
Stuart M Sprague, NorthShore University HealthSystem Research Institute
NorthShore University HealthSystem Research Institute
Shire Development LLC
Principal Investigator: Stuart M Sprague, DO NorthShore University HealthSystem
NorthShore University HealthSystem Research Institute
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP