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Completed

NCT Number: NCT00999037

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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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sevelamer carbonate

Drug

Daily renvela (800 mg tid with meals) x 12 weeks

Other names: Renvela

Placebo

Other

1 inert tablet tid x 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Loma Linda University

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Oct 21, 2009
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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