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Trial record 52 of 7858 for:    "Kidney Diseases"

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

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ClinicalTrials.gov Identifier: NCT00843349
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : June 7, 2013
Last Update Posted : June 7, 2013
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Kidney Disease
Interventions Drug: Lanthanum Carbonate
Other: 900 mg Phosphate Diet
Drug: LC Placebo
Other: Ad Libitum Diet
Enrollment 43
Recruitment Details 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 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.
Arm/Group Title 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
Hide Arm/Group Description dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate) no dietary intervention + phosphorus binder (Lanthanum Carbonate) dietary phosphorus restriction (900 mg/day of phosphorus) + Lanthanum Carbonate placebo no dietary intervention + Lanthanum Carbonate placebo
Period Title: Overall Study
Started 11 11 10 11
Completed 8 11 10 10
Not Completed 3 0 0 1
Arm/Group Title 900 mg Phosphate Diet-LC Ad Libitum Diet-LC 900 mg Phosphate Diet-LC Placebo Ad Libitum Diet-LC Placebo Total
Hide Arm/Group Description dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate) no dietary intervention + phosphorus binder (Lanthanum Carbonate) dietary phosphorus restriction (900 mg/day of phosphorus) + placebo no dietary intervention + placebo Total of all reporting groups
Overall Number of Baseline Participants 11 11 10 11 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 10 participants 11 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
  90.9%
9
  81.8%
8
  80.0%
9
  81.8%
36
  83.7%
>=65 years
1
   9.1%
2
  18.2%
2
  20.0%
2
  18.2%
7
  16.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 10 participants 11 participants 43 participants
56.1  (10.0) 55.1  (12.6) 56.2  (10.1) 55.1  (12.6) 55.4  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 10 participants 11 participants 43 participants
Female
3
  27.3%
3
  27.3%
3
  30.0%
5
  45.5%
14
  32.6%
Male
8
  72.7%
8
  72.7%
7
  70.0%
6
  54.5%
29
  67.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 10 participants 11 participants 43 participants
11 11 10 11 43
1.Primary Outcome
Title Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels
Hide Description Nonfasting blood was assessed over a period of 12 weeks. The primary endpoint was percentage change in FGF-23 levels from baseline.
Time Frame Week 0 - 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed their respective intervention periods were selected for analysis.
Arm/Group Title 900 mg Phosphate Diet-LC Ad Libitum Diet-LC 900 mg Phosphate Diet-LC Placebo Ad Libitum Diet-LC Placebo
Hide Arm/Group Description:
dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
no dietary intervention + phosphorus binder (Lanthanum Carbonate)
dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
no dietary intervention + placebo
Overall Number of Participants Analyzed 8 11 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
-0.35  (0.32) 0.25  (0.53) 0.00  (0.24) -0.02  (0.29)
2.Primary Outcome
Title Percentage Changes in Parathyroid Hormone (PTH) Levels
Hide Description Nonfasting blood was assessed over a period of 12 weeks. Endpoint was percentage changes in PTH levels from baseline.
Time Frame Week 0 - 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants that completed their respective intervention periods were selected for analysis.
Arm/Group Title 900 mg Phosphate Diet-LC Ad Libitum Diet-LC 900 mg Phosphate Diet-LC Placebo Ad Libitum Diet-LC Placebo
Hide Arm/Group Description:
dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
no dietary intervention + phosphorus binder (Lanthanum Carbonate)
dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
no dietary intervention + placebo
Overall Number of Participants Analyzed 8 11 10 10
Mean (Standard Deviation)
Unit of Measure: percentage of change from baseline
0.04  (0.45) 0.24  (0.42) 0.06  (0.22) 0.17  (0.62)
Time Frame Adverse event data was collected all throughout the study, from July 2009 to March 2012.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 900 mg Phosphate Diet-LC Ad Libitum Diet-LC 900 mg Phosphate Diet-LC Placebo Ad Libitum Diet-LC Placebo
Hide Arm/Group Description dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate) no dietary intervention + phosphorus binder (Lanthanum Carbonate) dietary phosphorus restriction (900 mg/day of phosphorus) + placebo no dietary intervention + placebo
All-Cause Mortality
900 mg Phosphate Diet-LC Ad Libitum Diet-LC 900 mg Phosphate Diet-LC Placebo Ad Libitum Diet-LC Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
900 mg Phosphate Diet-LC Ad Libitum Diet-LC 900 mg Phosphate Diet-LC Placebo Ad Libitum Diet-LC Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/11 (0.00%)      0/10 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
900 mg Phosphate Diet-LC Ad Libitum Diet-LC 900 mg Phosphate Diet-LC Placebo Ad Libitum Diet-LC Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/11 (36.36%)      1/11 (9.09%)      0/10 (0.00%)      3/11 (27.27%)    
Gastrointestinal disorders         
Nausea and vomiting  [1]  3/11 (27.27%)  3 0/11 (0.00%)  0 0/10 (0.00%)  0 2/11 (18.18%)  2
Metabolism and nutrition disorders         
Hypophosphatemia  [2]  1/11 (9.09%)  1 1/11 (9.09%)  1 0/10 (0.00%)  0 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
[1]
Moderate to severe nausea and vomiting
[2]
Low serum phosphate levels.
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: Dr. Myles Wolf, Associate Professor of Medicine, Chief-Division of Nephrology and Hypertension
Organization: University of Miami
Phone: 305-243-7745
Responsible Party: Myles Wolf, University of Miami
ClinicalTrials.gov Identifier: NCT00843349     History of Changes
Other Study ID Numbers: 20080536
R01DK076116 ( U.S. NIH Grant/Contract )
First Submitted: February 12, 2009
First Posted: February 13, 2009
Results First Submitted: February 7, 2013
Results First Posted: June 7, 2013
Last Update Posted: June 7, 2013