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Fibroblast Growth Factor-23 (FGF23) Reduction in Predialysis Chronic Kidney Disease (CKD)

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Myles Wolf, University of Miami
ClinicalTrials.gov Identifier:
NCT00843349
First received: February 12, 2009
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
Results First Received: February 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Kidney Disease
Interventions: Drug: Lanthanum Carbonate
Other: 900 mg Phosphate Diet
Drug: LC Placebo
Other: Ad Libitum Diet

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants in the study were enrolled between July 2009 and November 2011. Study team members identified potential participants from outpatient clinics at the University of Miami Nephrology Clinics and Jackson Health System Nephrology Clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After screening, the patients underwent a two-week run-in period encompassing three separate visits during which baseline blood and urine were collected, as well as baseline nutrition information.

Reporting Groups
  Description
900 mg Phosphate Diet-Lanthanum Carbonate (LC) dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
Ad Libitum Diet-Lanthanum Carbonate no dietary intervention + phosphorus binder (Lanthanum Carbonate)
900 mg Phosphate Diet-Lanthanum Carbonate Placebo dietary phosphorus restriction (900 mg/day of phosphorus) + Lanthanum Carbonate placebo
Ad Libitum Diet-Lanthanum Carbonate Placebo no dietary intervention + Lanthanum Carbonate placebo

Participant Flow:   Overall Study
    900 mg Phosphate Diet-Lanthanum Carbonate (LC)     Ad Libitum Diet-Lanthanum Carbonate     900 mg Phosphate Diet-Lanthanum Carbonate Placebo     Ad Libitum Diet-Lanthanum Carbonate Placebo  
STARTED     11     11     10     11  
COMPLETED     8     11     10     10  
NOT COMPLETED     3     0     0     1  



  Baseline Characteristics
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Reporting Groups
  Description
900 mg Phosphate Diet-LC dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
Ad Libitum Diet-LC no dietary intervention + phosphorus binder (Lanthanum Carbonate)
900 mg Phosphate Diet-LC Placebo dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
Ad Libitum Diet-LC Placebo no dietary intervention + placebo
Total Total of all reporting groups

Baseline Measures
    900 mg Phosphate Diet-LC     Ad Libitum Diet-LC     900 mg Phosphate Diet-LC Placebo     Ad Libitum Diet-LC Placebo     Total  
Number of Participants  
[units: participants]
 		  11     11     10     11     43  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     10     9     8     9     36  
>=65 years     1     2     2     2     7  
Age  
[units: years]
Mean ± Standard Deviation 		  56.1  ± 10.0     55.1  ± 12.6     56.2  ± 10.1     55.1  ± 12.6     55.4  ± 10.3  
Gender  
[units: participants]
 		         
Female     3     3     3     5     14  
Male     8     8     7     6     29  
Region of Enrollment  
[units: participants]
 		         
United States     11     11     10     11     43  



  Outcome Measures
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1.  Primary:   Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels   [ Time Frame: Week 0 - 12 ]
  Show Outcome Measure 1

2.  Primary:   Percentage Changes in Parathyroid Hormone (PTH) Levels   [ Time Frame: Week 0 - 12 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Myles Wolf, Associate Professor of Medicine, Chief-Division of Nephrology and Hypertension
Organization: University of Miami
phone: 305-243-7745
e-mail: mwolf@med.miami.edu


No publications provided


Responsible Party: Myles Wolf, University of Miami
ClinicalTrials.gov Identifier: NCT00843349     History of Changes
Other Study ID Numbers: 20080536, R01DK076116
Study First Received: February 12, 2009
Results First Received: February 7, 2013
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board