FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
Primary Purpose
Secondary Hyperparathyroidism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sevelamer Carbonate
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Secondary Hyperparathyroidism
Eligibility 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.
Sites / Locations
- UCLA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Renvela
placebo
Arm Description
Daily renvela with meals for 12 weeks
Outcomes
Primary Outcome Measures
Change in FGF-23 Level
Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.
Secondary Outcome Measures
1,25(OH)2vitamin D Value
Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.
Serum Phosphate Concentration
Change in serum phosphate at 12 weeks from baseline
Full Information
NCT ID
NCT00999037
First Posted
October 20, 2009
Last Updated
May 3, 2023
Sponsor
University of California, Los Angeles
Collaborators
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT00999037
Brief Title
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
Official Title
FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles
Collaborators
Loma Linda University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renvela
Arm Type
Experimental
Arm Description
Daily renvela with meals for 12 weeks
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sevelamer Carbonate
Other Intervention Name(s)
Renvela
Intervention Description
Daily renvela (800 mg tid with meals) x 12 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 inert tablet tid x 12 weeks
Primary Outcome Measure Information:
Title
Change in FGF-23 Level
Description
Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
1,25(OH)2vitamin D Value
Description
Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.
Time Frame
12 week
Title
Serum Phosphate Concentration
Description
Change in serum phosphate at 12 weeks from baseline
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
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FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
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