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FGF-23 (Fibroblast Growth Factor 23) Regulation 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: NCT00999037
Recruitment Status : Completed
First Posted : October 21, 2009
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Loma Linda University
Information provided by (Responsible Party):
Katherine Wesseling-Perry, University of California, Los Angeles

Brief Summary:
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 or disease Intervention/treatment
Secondary Hyperparathyroidism Drug: Sevelamer Carbonate Other: Placebo

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
Study Start Date : October 2009
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 1,25(OH)2vitamin D Value [ Time Frame: 12 week ]
    Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.

  2. Serum Phosphate Concentration [ Time Frame: 12 weeks ]
    Change in serum phosphate at 12 weeks from baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

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): NCT00999037

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

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 ( U.S. NIH Grant/Contract )
First Posted: October 21, 2009    Key Record Dates
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism, Secondary
Urologic Diseases
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Chelating Agents
Sequestering Agents