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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2015-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Secondary Hyperparathyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Renvela

Daily renvela with meals for 12 weeks

Group Type EXPERIMENTAL

Sevelamer Carbonate

Intervention Type DRUG

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

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

1 inert tablet tid x 12 weeks

Interventions

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Sevelamer Carbonate

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

Intervention Type DRUG

Placebo

1 inert tablet tid x 12 weeks

Intervention Type OTHER

Other Intervention Names

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Renvela

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No