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

This study has been completed.
Sponsor:
Collaborator:
Loma Linda University
Information provided by (Responsible Party):
Katherine Wesseling-Perry, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00999037
First received: October 20, 2009
Last updated: February 14, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Secondary Hyperparathyroidism Drug: Sevelamer Carbonate Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Prevention
Official Title: FGF-23 (Fibroblast Growth Factor 23) Regulation in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Katherine Wesseling-Perry, University of California, Los Angeles:

Primary Outcome Measures:
  • Change in FGF-23 Level [ Time Frame: 12 weeks ]
    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 [ Time Frame: 12 week ]
    Percentage change in 1,25(OH)2vitamin D level from baseline at 12 weeks.

  • Serum Phosphate Concentration [ Time Frame: 12 weeks ]
    Change in serum phosphate at 12 weeks from baseline


Enrollment: 18
Study Start Date: October 2009
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renvela
Daily renvela with meals for 12 weeks
Drug: Sevelamer Carbonate
Daily renvela (800 mg tid with meals) x 12 weeks
Other Name: Renvela
Placebo Comparator: placebo Other: Placebo
1 inert tablet tid x 12 weeks

  Eligibility

Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999037

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Loma Linda University
  More Information

Responsible Party: Katherine Wesseling-Perry, Assistant Professor of Pediatrics, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00999037     History of Changes
Other Study ID Numbers: 1K23DK080984-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: October 20, 2009
Results First Received: December 22, 2016
Last Updated: February 14, 2017

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Insufficiency
Urologic Diseases
Parathyroid Diseases
Endocrine System Diseases
Mitogens
Sevelamer
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Chelating Agents
Sequestering Agents

ClinicalTrials.gov processed this record on June 21, 2017