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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01002872
Recruitment Status : Unknown
Verified March 2012 by Stuart M Sprague, NorthShore University HealthSystem.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2009
Last Update Posted : March 8, 2012
Information provided by (Responsible Party):
Stuart M Sprague, NorthShore University HealthSystem

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 FGF23 measurement in CKD patients may impact both the progression of kidney disease and patient mortality.

Condition or disease Intervention/treatment Phase
Metabolic Bone Disease Drug: Lanthanum Carbonate Drug: Fosrenol Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 (FGF23 ) in Chronic Kidney Disease
Study Start Date : October 2009
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: Lanthanum Carbonate 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

Placebo Comparator: Placebo Drug: placebo
Initial dose of placebo will be 1 pill three times a day
Other Name: sugar pill

Primary Outcome Measures :
  1. Assess the effects on Lanthanum Carbonate on c terminal and intact FGF 23 level [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Change from baseline serum calcium and albumin [ Time Frame: 60 days ]
  2. Change from baseline serum phosphate [ Time Frame: 60 days ]
  3. Change from baseline serum parathyroid hormone [ Time Frame: 60 days ]
  4. Change from baseline 1,25 dihydroxyvitamin D 3 [ Time Frame: 60 days ]
  5. Change from baseline 25 hydroxyvitamin D [ Time Frame: 60 days ]
  6. Change from baseline serum alkaline phosphatase [ Time Frame: 60 days ]
  7. Change from baseline serum osteocalcin [ Time Frame: 60 days ]
  8. Change from baseline 24 hour urine, calcium,phosphorus, creatinine [ Time Frame: 60 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01002872

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United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem
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Principal Investigator: Stuart M Sprague, DO NorthShore University HealthSystem
Publications of Results:
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Responsible Party: Stuart M Sprague, Chief, Division of Nephrology and Hypertension Professor of Medicine University of Chicago Medical School, NorthShore University HealthSystem Identifier: NCT01002872    
Other Study ID Numbers: EH 09-156
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012
Keywords provided by Stuart M Sprague, NorthShore University HealthSystem:
Additional relevant MeSH terms:
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Bone Diseases
Bone Diseases, Metabolic
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Musculoskeletal Diseases
Metabolic Diseases