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

This study has been completed.
Loma Linda University
Information provided by (Responsible Party):
Katherine Wesseling-Perry, University of California, Los Angeles Identifier:
First received: October 20, 2009
Last updated: February 2, 2016
Last verified: December 2014
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.

Condition Intervention
Secondary Hyperparathyroidism
Drug: Sevelamer Carbonate
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in FGF-23 level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1,25(OH)2vitamin D value [ Time Frame: 12 weekx ] [ Designated as safety issue: No ]
  • Serum Phosphate Concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2009
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renvela
Daily renvela with meals for 12 weeks
Drug: Sevelamer Carbonate
Daily renvela (800 mg tid with meals) x 12 weeks
Other Name: Renvela
Placebo Comparator: placebo Other: Placebo
1 inert tablet tid x 12 weeks


Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00999037

United States, California
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Loma Linda University
  More Information

Responsible Party: Katherine Wesseling-Perry, Assistant Professor of Pediatrics, University of California, Los Angeles Identifier: NCT00999037     History of Changes
Other Study ID Numbers: 1K23DK080984-01A1 
Study First Received: October 20, 2009
Last Updated: February 2, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016