Trial Outcomes & Findings for Fibroblast Growth Factor-23 (FGF23) Reduction in Predialysis Chronic Kidney Disease (CKD) (NCT NCT00843349)
NCT ID: NCT00843349
Last Updated: 2013-06-07
Results Overview
Nonfasting blood was assessed over a period of 12 weeks. The primary endpoint was percentage change in FGF-23 levels from baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
Week 0 - 12
Results posted on
2013-06-07
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
10
|
11
|
|
Overall Study
COMPLETED
|
8
|
11
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fibroblast Growth Factor-23 (FGF23) Reduction in Predialysis Chronic Kidney Disease (CKD)
Baseline characteristics by cohort
| Measure |
900 mg Phosphate Diet-LC
n=11 Participants
dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
|
Ad Libitum Diet-LC
n=11 Participants
no dietary intervention + phosphorus binder (Lanthanum Carbonate)
|
900 mg Phosphate Diet-LC Placebo
n=10 Participants
dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
|
Ad Libitum Diet-LC Placebo
n=11 Participants
no dietary intervention + placebo
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age Continuous
|
56.1 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
55.1 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
55.4 years
STANDARD_DEVIATION 10.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
11 participants
n=4 Participants
|
43 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 0 - 12Population: All participants that completed their respective intervention periods were selected for analysis.
Nonfasting blood was assessed over a period of 12 weeks. The primary endpoint was percentage change in FGF-23 levels from baseline.
Outcome measures
| Measure |
900 mg Phosphate Diet-LC
n=8 Participants
dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
|
Ad Libitum Diet-LC
n=11 Participants
no dietary intervention + phosphorus binder (Lanthanum Carbonate)
|
900 mg Phosphate Diet-LC Placebo
n=10 Participants
dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
|
Ad Libitum Diet-LC Placebo
n=10 Participants
no dietary intervention + placebo
|
|---|---|---|---|---|
|
Percentage Changes in Fibroblast Growth Factor-23 (FGF-23) Levels
|
-0.35 percentage of change from baseline
Standard Deviation 0.32
|
0.25 percentage of change from baseline
Standard Deviation 0.53
|
0.00 percentage of change from baseline
Standard Deviation 0.24
|
-0.02 percentage of change from baseline
Standard Deviation 0.29
|
PRIMARY outcome
Timeframe: Week 0 - 12Population: All participants that completed their respective intervention periods were selected for analysis.
Nonfasting blood was assessed over a period of 12 weeks. Endpoint was percentage changes in PTH levels from baseline.
Outcome measures
| Measure |
900 mg Phosphate Diet-LC
n=8 Participants
dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
|
Ad Libitum Diet-LC
n=11 Participants
no dietary intervention + phosphorus binder (Lanthanum Carbonate)
|
900 mg Phosphate Diet-LC Placebo
n=10 Participants
dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
|
Ad Libitum Diet-LC Placebo
n=10 Participants
no dietary intervention + placebo
|
|---|---|---|---|---|
|
Percentage Changes in Parathyroid Hormone (PTH) Levels
|
0.04 percentage of change from baseline
Standard Deviation 0.45
|
0.24 percentage of change from baseline
Standard Deviation 0.42
|
0.06 percentage of change from baseline
Standard Deviation 0.22
|
0.17 percentage of change from baseline
Standard Deviation 0.62
|
Adverse Events
900 mg Phosphate Diet-LC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Ad Libitum Diet-LC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
900 mg Phosphate Diet-LC Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ad Libitum Diet-LC Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
900 mg Phosphate Diet-LC
n=11 participants at risk
dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
|
Ad Libitum Diet-LC
n=11 participants at risk
no dietary intervention + phosphorus binder (Lanthanum Carbonate)
|
900 mg Phosphate Diet-LC Placebo
n=10 participants at risk
dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
|
Ad Libitum Diet-LC Placebo
n=11 participants at risk
no dietary intervention + placebo
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea and vomiting
|
27.3%
3/11 • Number of events 3 • Adverse event data was collected all throughout the study, from July 2009 to March 2012.
|
0.00%
0/11 • Adverse event data was collected all throughout the study, from July 2009 to March 2012.
|
0.00%
0/10 • Adverse event data was collected all throughout the study, from July 2009 to March 2012.
|
18.2%
2/11 • Number of events 2 • Adverse event data was collected all throughout the study, from July 2009 to March 2012.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
9.1%
1/11 • Number of events 1 • Adverse event data was collected all throughout the study, from July 2009 to March 2012.
|
9.1%
1/11 • Number of events 1 • Adverse event data was collected all throughout the study, from July 2009 to March 2012.
|
0.00%
0/10 • Adverse event data was collected all throughout the study, from July 2009 to March 2012.
|
9.1%
1/11 • Number of events 1 • Adverse event data was collected all throughout the study, from July 2009 to March 2012.
|
Additional Information
Dr. Myles Wolf, Associate Professor of Medicine, Chief-Division of Nephrology and Hypertension
University of Miami
Phone: 305-243-7745
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place