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

University of California, Los Angeles (UCLA) logo

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

Secondary Hyperparathyroidism

Treatments

Drug: Sevelamer Carbonate
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00999037
1K23DK080984-01A1

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

6 to 21 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

18 participants in 2 patient groups, including a placebo group

Renvela
Experimental group
Description:
Daily renvela with meals for 12 weeks
Treatment:
Drug: Sevelamer Carbonate
placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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