Trial Outcomes & Findings for Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease (NCT NCT00438932)
NCT ID: NCT00438932
Last Updated: 2011-09-27
Results Overview
Plasma FGF-23 was measured using c-terminal FGF23 assay.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
2 weeks
Results posted on
2011-09-27
Participant Flow
16 patients completed the full study. Patients were recruited from renal clinics.
There was no wash-out, run in or transition.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Lanthanum Carbonate & Low Phosphorous Diet
n=4 Participants
Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
|
Lanthanum Carbonate & Unrestricted Phosphorous Diet
n=4 Participants
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
n=4 Participants
Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
|
Placebo & Unrestricted Phosphorous Diet
n=4 Participants
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
n=16 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age Continuous
|
63 years
STANDARD_DEVIATION 11 • n=5 Participants
|
62 years
STANDARD_DEVIATION 13 • n=7 Participants
|
56 years
STANDARD_DEVIATION 21 • n=5 Participants
|
68 years
STANDARD_DEVIATION 17 • n=4 Participants
|
62 years
STANDARD_DEVIATION 15 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
4 participants
n=4 Participants
|
16 participants
n=21 Participants
|
|
Fibroblast Growth Factor 23 (FGF-23)
|
164.3 Ru/ml
STANDARD_DEVIATION 110.9 • n=5 Participants
|
263.1 Ru/ml
STANDARD_DEVIATION 167.9 • n=7 Participants
|
178.8 Ru/ml
STANDARD_DEVIATION 97.6 • n=5 Participants
|
121.8 Ru/ml
STANDARD_DEVIATION 60.0 • n=4 Participants
|
182.0 Ru/ml
STANDARD_DEVIATION 116.3 • n=21 Participants
|
|
24-hr urine phosphate
|
659.0 mg
STANDARD_DEVIATION 269.8 • n=5 Participants
|
761.8 mg
STANDARD_DEVIATION 77.4 • n=7 Participants
|
745.4 mg
STANDARD_DEVIATION 287.0 • n=5 Participants
|
934.6 mg
STANDARD_DEVIATION 545.5 • n=4 Participants
|
775.2 mg
STANDARD_DEVIATION 320.0 • n=21 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPlasma FGF-23 was measured using c-terminal FGF23 assay.
Outcome measures
| Measure |
Lanthanum Carbonate & Low Phosphorous Diet
n=4 Participants
Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
|
Lanthanum Carbonate & Unrestricted Phosphorous Diet
n=4 Participants
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
n=4 Participants
Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
|
Placebo & Unrestricted Phosphorous Diet
n=4 Participants
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.
|
|---|---|---|---|---|
|
Fibroblast Growth Factor 23 (FGF-23)
|
162.695 RU/ml
Standard Error 56.170737
|
297 RU/ml
Standard Error 77.69778
|
188.975 RU/ml
Standard Error 60.2020815
|
143.7675 RU/ml
Standard Error 37.507486
|
SECONDARY outcome
Timeframe: 2 weeksfrom 24-hr urine collections
Outcome measures
| Measure |
Lanthanum Carbonate & Low Phosphorous Diet
n=4 Participants
Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
|
Lanthanum Carbonate & Unrestricted Phosphorous Diet
n=4 Participants
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
n=4 Participants
Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
|
Placebo & Unrestricted Phosphorous Diet
n=4 Participants
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.
|
|---|---|---|---|---|
|
24-hour Urinary Phosphate
|
150.4 mg
Standard Error 49.3063045
|
382.725 mg
Standard Error 7.0577825
|
346.8 mg
Standard Error 132.671329
|
830.25 mg
Standard Error 220.003449
|
Adverse Events
Lanthanum Carbonate & Low Phosphorous Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lanthanum Carbonate & Unrestricted Phosphorous Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo & Low Phosphorous Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo & Unrestricted Phosphorous Diet
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tamara Isakova, MD, MMSc
University of Miami Miller School of Medicine
Phone: 305-243-4374
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place