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FGF-23 Regulation in Chronic Kidney Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of California, Los Angeles.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Loma Linda University
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00999037
First received: October 20, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 20, 2009
October 20, 2009
October 2009
October 2011   (final data collection date for primary outcome measure)
Change in FGF-23 level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 1,25(OH)2vitamin D value [ Time Frame: 12 weekx ] [ Designated as safety issue: No ]
  • Serum Phosphate Concentration [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
FGF-23 Regulation in Chronic Kidney Disease
Not Provided

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Secondary Hyperparathyroidism
  • Drug: Sevelamer Carbonate
    Daily renvela (800 mg tid with meals) x 12 weeks
    Other Name: Renvela
  • Other: Placebo
    1 inert tablet tid x 12 weeks
  • Experimental: Renvela
    Daily renvela with meals for 12 weeks
    Intervention: Drug: Sevelamer Carbonate
  • Placebo Comparator: placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
Not Provided
October 2011   (final data collection date for primary outcome measure)

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.
Both
6 Years to 21 Years
No
Contact: Katherine Wesseling-Perry, MD 310-206-6987 kwesseling@mednet.ucla.edu
United States
 
NCT00999037
1K23DK080984-01A1
Yes
Katherine Wesseling-Perry, Univeristy of California, Los Angeles
University of California, Los Angeles
Loma Linda University
Not Provided
University of California, Los Angeles
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP