FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 20, 2009
CompletedFirst Posted
Study publicly available on registry
October 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
March 31, 2017
CompletedMay 31, 2023
May 1, 2023
5.7 years
October 20, 2009
December 22, 2016
May 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in FGF-23 Level
Change in FGF23 value from baseline in response to Renvela at 12 weeks in comparison to placebo.
12 weeks
Secondary Outcomes (2)
1,25(OH)2vitamin D Value
12 week
Serum Phosphate Concentration
12 weeks
Study Arms (2)
Renvela
EXPERIMENTALDaily renvela with meals for 12 weeks
placebo
PLACEBO COMPARATORInterventions
Daily renvela (800 mg tid with meals) x 12 weeks
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Los Angeleslead
- Loma Linda Universitycollaborator
Study Sites (1)
UCLA
Los Angeles, California, 90095, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Katherine Wesseling-Perry
- Organization
- University of California at Los Angeles
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2009
First Posted
October 21, 2009
Study Start
October 1, 2009
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 31, 2023
Results First Posted
March 31, 2017
Record last verified: 2023-05