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FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT00999037
Recruitment Status : Completed
First Posted : October 21, 2009
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Information provided by (Responsible Party):

October 20, 2009
October 21, 2009
December 22, 2016
March 31, 2017
March 31, 2017
October 2009
June 2015   (Final data collection date for primary outcome measure)
Change in FGF-23 Level [ Time Frame: 12 weeks ]
Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.
Change in FGF-23 Level [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00999037 on ClinicalTrials.gov Archive Site
  • 1,25(OH)2vitamin D Value [ Time Frame: 12 week ]
    Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.
  • Serum Phosphate Concentration [ Time Frame: 12 weeks ]
    Change in serum phosphate at 12 weeks from baseline
  • 1,25(OH)2vitamin D Value [ Time Frame: 12 weekx ]
  • Serum Phosphate Concentration [ Time Frame: 12 weeks ]
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FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
FGF-23 is a newly described protein that is an important regulator of phosphorus in the body. This protein increases in people with kidney disease and people who need dialysis have very high levels of FGF-23 in the blood. However, although some studies have indicated that FGF-23 levels go up with increased intake of phosphorus, no one knows if FGF-23 levels can be lowered in patients with kidney disease by preventing them from absorbing phosphorus from food. This study is designed to see what happens to levels of FGF-23 in the blood when patients with chronic kidney disease take medications to prevent phosphorus absorption. Since high levels of FGF-23 have been linked with increased rates of death in patients with advanced kidney disease, controlling the levels may, in the future, be a way to decrease heart disease in patients with kidney disease.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Secondary Hyperparathyroidism
  • Drug: Sevelamer Carbonate
    Daily renvela (800 mg tid with meals) x 12 weeks
    Other Name: Renvela
  • Other: Placebo
    1 inert tablet tid x 12 weeks
  • Experimental: Renvela
    Daily renvela with meals for 12 weeks
    Intervention: Drug: Sevelamer Carbonate
  • Placebo Comparator: placebo
    Intervention: Other: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2015
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Inclusion criteria include pediatric patients, between the ages of 2 and 21 years, with CKD stages 2-4 (GFR 15-90 ml/min/1.73m2).

Exclusion Criteria:

  • Exclusion criteria include: the use of phosphate binder therapy within the past 3 months, treatment with 25(OH)vitamin D or 1,25dihydroxyvitamin D, underlying metabolic bone disease, or underlying renal phosphate wasting disorder.
Sexes Eligible for Study: All
6 Years to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
1K23DK080984-01A1( U.S. NIH Grant/Contract )
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Katherine Wesseling-Perry, University of California, Los Angeles
University of California, Los Angeles
Loma Linda University
Not Provided
University of California, Los Angeles
February 2017

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