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Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease

This study has been completed.
Sponsor:
Collaborator:
Shire Development LLC
Information provided by (Responsible Party):
Myles S. Wolf, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438932
First received: February 20, 2007
Last updated: September 23, 2011
Last verified: September 2011
History of Changes
Results First Received: July 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Chronic Kidney Disease
Interventions: Drug: Lanthanum Carbonate
Dietary Supplement: Low Phosphorus Diet
Dietary Supplement: Unrestricted Phosphorus Diet
Drug: Placebo

  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
16 patients completed the full study. Patients were recruited from renal clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no wash-out, run in or transition.

Reporting Groups
  Description
Lanthanum Carbonate & Low Phosphorous Diet Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
Lanthanum Carbonate & Unrestricted Phosphorous Diet Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
Placebo & Low Phosphorous Diet Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
Placebo & Unrestricted Phosphorous Diet Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.

Participant Flow:   Overall Study
    Lanthanum Carbonate & Low Phosphorous Diet     Lanthanum Carbonate & Unrestricted Phosphorous Diet     Placebo & Low Phosphorous Diet     Placebo & Unrestricted Phosphorous Diet  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Lanthanum Carbonate & Low Phosphorous Diet Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
Lanthanum Carbonate & Unrestricted Phosphorous Diet Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
Placebo & Low Phosphorous Diet Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
Placebo & Unrestricted Phosphorous Diet Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
Total Total of all reporting groups

Baseline Measures
    Lanthanum Carbonate & Low Phosphorous Diet     Lanthanum Carbonate & Unrestricted Phosphorous Diet     Placebo & Low Phosphorous Diet     Placebo & Unrestricted Phosphorous Diet     Total  
Number of Participants  
[units: participants]
 		  4     4     4     4     16  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     3     3     2     2     10  
>=65 years     1     1     2     2     6  
Age  
[units: years]
Mean ± Standard Deviation 		  63  ± 11     62  ± 13     56  ± 21     68  ± 17     62  ± 15  
Gender  
[units: participants]
 		         
Female     1     0     0     0     1  
Male     3     4     4     4     15  
Region of Enrollment  
[units: participants]
 		         
United States     4     4     4     4     16  
Fibroblast Growth Factor 23 (FGF-23) [1]
[units: Ru/ml]
Mean ± Standard Deviation 		  164.3  ± 110.9     263.1  ± 167.9     178.8  ± 97.6     121.8  ± 60.0     182.0  ± 116.3  
24-hr urine phosphate [2]
[units: mg]
Mean ± Standard Deviation 		  659.0  ± 269.8     761.8  ± 77.4     745.4  ± 287.0     934.6  ± 545.5     775.2  ± 320.0  
[1] Plasma FGF-23 at the baseline visit was measured using C-terminal FGF23 assay.
[2] measured from 24 hour urine collections; 2 separate collections were obtained; values are means of the two collections; pre-intervention



  Outcome Measures
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1.  Primary:   Fibroblast Growth Factor 23 (FGF-23)   [ Time Frame: 2 weeks ]
  Show Outcome Measure 1

2.  Secondary:   24-hour Urinary Phosphate   [ Time Frame: 2 weeks ]
  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
In addition to limited power, the small sample size led to imbalances in baseline laboratory tests, which added further variability to the analyses. .  


Results Point of Contact:  
Name/Title: Tamara Isakova, MD, MMSc
Organization: University of Miami Miller School of Medicine
phone: 305-243-4374
e-mail: tisakova@med.miami.edu


Publications of Results:


Responsible Party: Myles S. Wolf, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438932     History of Changes
Other Study ID Numbers: 2005P000486
Study First Received: February 20, 2007
Results First Received: July 25, 2011
Last Updated: September 23, 2011
Health Authority: United States: Food and Drug Administration