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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00999037
Recruitment Status : Completed
First Posted : October 21, 2009
Results First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Loma Linda University
Information provided by (Responsible Party):
Katherine Wesseling-Perry, University of California, Los Angeles

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition: Secondary Hyperparathyroidism
Interventions: Drug: Sevelamer Carbonate
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Renvela Sevelamer Carbonate (Renvela) 800 mg tablets: 1 tablet TID with meals for 12 weeks
Placebo Placebo (inert tablets): 1 tablet TID with meals for 12 weeks

Participant Flow:   Overall Study
    Renvela   Placebo
STARTED   9   9 [1] 
COMPLETED   9   9 
[1] 20

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

Daily renvela with meals for 12 weeks

Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks

Placebo Placebo: 1 inert tablet tid x 12 weeks
Total Total of all reporting groups

Baseline Measures
   Renvela   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   9   18 
[Units: Participants]
Count of Participants
<=18 years      9 100.0%      6  66.7%      15  83.3% 
Between 18 and 65 years      0   0.0%      3  33.3%      3  16.7% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
[Units: Years]
Mean (Standard Deviation)
 13.3  (3.2)   15.4  (4.6)   14.3  (4.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      5  55.6%      4  44.4%      9  50.0% 
Male      4  44.4%      5  55.6%      9  50.0% 
Region of Enrollment 
[Units: Participants]
United States   9   9   18 

  Outcome Measures

1.  Primary:   Change in FGF-23 Level   [ Time Frame: 12 weeks ]

2.  Secondary:   1,25(OH)2vitamin D Value   [ Time Frame: 12 week ]

3.  Secondary:   Serum Phosphate Concentration   [ Time Frame: 12 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Katherine Wesseling-Perry
Organization: University of California at Los Angeles
phone: 310-206-6987

Responsible Party: Katherine Wesseling-Perry, University of California, Los Angeles Identifier: NCT00999037     History of Changes
Other Study ID Numbers: 1K23DK080984-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 20, 2009
First Posted: October 21, 2009
Results First Submitted: December 22, 2016
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017