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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
  Purpose

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 Intervention
Metabolic Bone Disease
 Drug: Lanthanum Carbonate
Drug: Fosrenol
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23 (FGF23 ) in Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • Assess the effects on Lanthanum Carbonate on c terminal and intact FGF 23 level [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Fosrenol
Placebo Comparator: Placebo Drug: placebo
Initial dose of placebo will be 1 pill three times a day
Other Name: sugar pill

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01002872

Locations
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sponsors and Collaborators
NorthShore University HealthSystem Research Institute
Shire Development LLC
Investigators
Principal Investigator: Stuart M Sprague, DO NorthShore University HealthSystem
  More Information

Publications:

Responsible Party: Stuart M Sprague, Chief, Division of Nephrology and Hypertension Professor of Medicine University of Chicago Medical School, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT01002872     History of Changes
Other Study ID Numbers: EH 09-156
Study First Received: October 27, 2009
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem Research Institute:
FGF23
CKD
Fosrenol
Hyperphosphatemia

Additional relevant MeSH terms:
Bone Diseases
Bone Diseases, Metabolic
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Musculoskeletal Diseases
 Urologic Diseases
Renal Insufficiency
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013