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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Change in FGF-23 level [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: October 2009
Estimated Primary Completion Date: October 2011 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Katherine Wesseling-Perry, MD 310-206-6987 kwesseling@mednet.ucla.edu

Locations
United States, California
UCLA Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Katherine Wesseling-Perry, MD    310-206-6987      
Sponsors and Collaborators
University of California, Los Angeles
Loma Linda University
  More Information

No publications provided

Responsible Party: Katherine Wesseling-Perry, Univeristy of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00999037     History of Changes
Other Study ID Numbers: 1K23DK080984-01A1
Study First Received: October 20, 2009
Last Updated: October 20, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014