Trial Outcomes & Findings for Phosphate Lowering in CKD Trial (NCT NCT02209636)
NCT ID: NCT02209636
Last Updated: 2022-08-26
Results Overview
Measurement of how well the brachial artery dilates in response to shear stress. It is a measure of endothelial function. It is reported as "percent change", which represents the change in dilation of the artery before and after occlusion. Brachial artery flow-mediated dilation will be measured at baseline and at 12 weeks (end-of-study) in the treatment and placebo groups to determine if there is a change brachial artery flow mediated dilation from baseline to 12 weeks and if this change is significantly different between the treatment and placebo groups.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
66 participants
Primary outcome timeframe
baseline and 12 weeks
Results posted on
2022-08-26
Participant Flow
N = 66 completed screening and signed consent so were considered enrolled; however, N = 5 did not receive allocated intervention because N = 3 withdrew consent, N = 1 had uncontrolled hypertension after screening, and N =1 had phosphorus levels that were too low to receive study drug after screening.
Participant milestones
| Measure |
Lanthanum Carbonate
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
|---|---|---|
|
Main/Parent Study
STARTED
|
32
|
29
|
|
Main/Parent Study
COMPLETED
|
27
|
27
|
|
Main/Parent Study
NOT COMPLETED
|
5
|
2
|
|
Balance Sub-study
STARTED
|
7
|
8
|
|
Balance Sub-study
COMPLETED
|
6
|
8
|
|
Balance Sub-study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phosphate Lowering in CKD Trial
Baseline characteristics by cohort
| Measure |
Lanthanum Carbonate
n=32 Participants
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
n=29 Participants
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 8 • n=5 Participants
|
65 years
STANDARD_DEVIATION 8 • n=7 Participants
|
66 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: Participants were analyzed if they had baseline and end-of-study FMD measurements and the measurements were of sufficient quality to be analyzed.
Measurement of how well the brachial artery dilates in response to shear stress. It is a measure of endothelial function. It is reported as "percent change", which represents the change in dilation of the artery before and after occlusion. Brachial artery flow-mediated dilation will be measured at baseline and at 12 weeks (end-of-study) in the treatment and placebo groups to determine if there is a change brachial artery flow mediated dilation from baseline to 12 weeks and if this change is significantly different between the treatment and placebo groups.
Outcome measures
| Measure |
Lanthanum Carbonate
n=25 Participants
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
n=27 Participants
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
|---|---|---|
|
Brachial Artery Flow-mediated Dilation
baseline
|
3.13 percent change FMD
Standard Deviation 2.87
|
3.74 percent change FMD
Standard Deviation 2.86
|
|
Brachial Artery Flow-mediated Dilation
week 12
|
2.73 percent change FMD
Standard Deviation 2.48
|
3.09 percent change FMD
Standard Deviation 2.49
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: Participants were included if they had baseline and end of study aPWV measurements and aPWV measurements were of sufficient quality to be analyzed.
The speed that blood travels from the carotid artery to the femoral artery, expressed as cm/s (centimeters/second). It is a measure of arterial stiffness. Aortic pulse-wave velocity will be measured at baseline and at 12 weeks (end-of-study) in the treatment and placebo groups to determine if there is a change aortic pulse wave velocity from baseline to 12 weeks and if this change is significantly different between the treatment and placebo groups.
Outcome measures
| Measure |
Lanthanum Carbonate
n=25 Participants
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
n=25 Participants
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
|---|---|---|
|
Aortic Pulse-wave Velocity
baseline
|
1214 change in aPWV, cm/s
Standard Deviation 394
|
993 change in aPWV, cm/s
Standard Deviation 289
|
|
Aortic Pulse-wave Velocity
week 12
|
1216 change in aPWV, cm/s
Standard Deviation 321
|
977 change in aPWV, cm/s
Standard Deviation 254
|
PRIMARY outcome
Timeframe: 9 days from the start of the sub-study, approximately 13 weeks and 2 days from the start of the Main/Parent StudyPopulation: Subjects who participated in the Phosphorus Balance sub-study and had sufficient stool volume for analysis.
Balance is defined as oral intake minus urine output minus stool output.
Outcome measures
| Measure |
Lanthanum Carbonate
n=6 Participants
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
n=8 Participants
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
|---|---|---|
|
Phosphorus Balance Sub-study (COMIRB 15-0384)
|
-131 mg/d
Standard Deviation 163
|
320 mg/d
Standard Deviation 141
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Participants were included if they had baseline and end of study FMD measurements, FMD measurements were of sufficient quality to be analyzed, and were able to receive ascorbic acid infusion.
The influence of oxidative stress on FMD will be determined by infusing a supraphysiologic dose of ascorbic acid or isovolemic saline. The difference in FMD, expressed as percentage change in FMD, which represents the change in dilation of the artery before and after occlusion, during ascorbic acid vs. saline infusion will be taken as a measure of the modulation of EDD/stiffness by oxidative stress.
Outcome measures
| Measure |
Lanthanum Carbonate
n=22 Participants
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
n=24 Participants
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
|---|---|---|
|
Oxidative Stress-associated Suppression of EDD
baseline FMD
|
2.91 percent change in FMD
Standard Deviation 2.81
|
3.54 percent change in FMD
Standard Deviation 2.86
|
|
Oxidative Stress-associated Suppression of EDD
baseline FMD after ascorbic acid
|
3.24 percent change in FMD
Standard Deviation 3.48
|
3.44 percent change in FMD
Standard Deviation 2.70
|
|
Oxidative Stress-associated Suppression of EDD
week 12 FMD
|
2.48 percent change in FMD
Standard Deviation 2.54
|
2.95 percent change in FMD
Standard Deviation 2.10
|
|
Oxidative Stress-associated Suppression of EDD
week 12 FMD w/ ascorbic acid
|
3.44 percent change in FMD
Standard Deviation 3.19
|
3.69 percent change in FMD
Standard Deviation 3.03
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Participants with sufficient number of collected endothelial cells for analysis.
Measures of different protein markers on endothelial cells. Will help understand the underlying pathophysiology of vascular dysfunction in chronic kidney disease. Vascular endothelial cell protein expression will be measured at baseline and at 12 weeks (end-of-study) in the treatment and placebo groups to determine if there is a change vascular endothelial cell protein expression from baseline to 12 weeks and if this change is significantly different between the treatment and placebo groups. The expression of endothelial cells collected from patients will be compared to the expression in HUVEC (human umbilical vein endothelial cell) controls and this ratio will be reported as the outcomes measure.
Outcome measures
| Measure |
Lanthanum Carbonate
n=17 Participants
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
n=14 Participants
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
|---|---|---|
|
Vascular Endothelial Cell Protein Expression
week 12
|
1.44 ratio
Standard Deviation 0.26
|
1.40 ratio
Standard Deviation 0.15
|
|
Vascular Endothelial Cell Protein Expression
baseline
|
1.54 ratio
Standard Deviation 0.31
|
1.41 ratio
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Participants were included if they had baseline and end of study blood collected.
This is a blood test. Interleukin-6 and C-reactive protein will be measured at baseline and at 12 weeks (end-of-study) in the treatment and placebo groups to determine if there is a change in interleukin-6 and C-reactive protein from baseline to 12 weeks and if this change is significantly different between the treatment and placebo groups.
Outcome measures
| Measure |
Lanthanum Carbonate
n=27 Participants
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
n=27 Participants
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
|---|---|---|
|
Interleukin-6 to Measure Systemic Inflammation
Interleukin-6, week 12
|
1.61 pg/ml
Interval 1.12 to 2.56
|
1.34 pg/ml
Interval 0.88 to 2.68
|
|
Interleukin-6 to Measure Systemic Inflammation
Interleukin-6, baseline
|
1.58 pg/ml
Interval 1.06 to 2.36
|
1.28 pg/ml
Interval 0.93 to 2.2
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Participants were included if they had blood collected at baseline and end of study.
This is a blood test art. Oxidized low-density lipoprotein (ox-LDL) will be measured at baseline and at 12 weeks (end-of-study) in the treatment and placebo groups to determine if there is a change in ox-LDL from baseline to 12 weeks and if this change is significantly different between the treatment and placebo groups.
Outcome measures
| Measure |
Lanthanum Carbonate
n=27 Participants
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
n=27 Participants
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
|---|---|---|
|
Oxidized Low-density Lipoprotein (Ox-LDL) to Measure Systemic Oxidized Stress
baseline
|
61837 mU/ml
Interval 49168.0 to 81461.0
|
62927 mU/ml
Interval 49634.0 to 82774.0
|
|
Oxidized Low-density Lipoprotein (Ox-LDL) to Measure Systemic Oxidized Stress
week 12
|
59725 mU/ml
Interval 48650.0 to 86949.0
|
68057 mU/ml
Interval 52199.0 to 78069.0
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Participants were included if they had baseline and end of study blood collected.
This is a blood test. C-reactive protein will be measured at baseline and at 12 weeks (end-of-study) in the treatment and placebo groups to determine if there is a change in C-reactive protein from baseline to 12 weeks and if this change is significantly different between the treatment and placebo groups.
Outcome measures
| Measure |
Lanthanum Carbonate
n=27 Participants
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
n=27 Participants
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
|---|---|---|
|
C-reactive Protein to Measure Systemic Inflammation
C-reactive protein, baseline
|
2.92 mg/ml
Interval 1.36 to 6.61
|
2.72 mg/ml
Interval 1.06 to 5.95
|
|
C-reactive Protein to Measure Systemic Inflammation
C-reactive protein, week 12
|
3.06 mg/ml
Interval 1.02 to 5.93
|
2.24 mg/ml
Interval 1.18 to 3.95
|
Adverse Events
Lanthanum Carbonate
Serious events: 3 serious events
Other events: 12 other events
Deaths: 1 deaths
Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Lanthanum Carbonate- Phosphorus Balance Sub-study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo- Phosphorus Balance Sub-study
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lanthanum Carbonate
n=32 participants at risk
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
n=29 participants at risk
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Lanthanum Carbonate- Phosphorus Balance Sub-study
n=7 participants at risk
Continued randomized intervention from Parent/Main Study on and received a fixed phosphorus diet for 9 days after the completion of the Parent/Main Study.
|
Placebo- Phosphorus Balance Sub-study
n=8 participants at risk
Continued randomized intervention from Parent/Main Study on and received a fixed phosphorus diet for 9 days after the completion og the Parent/Main Study.
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Hospitalization
|
3.1%
1/32 • Number of events 1 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
0.00%
0/29 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
0.00%
0/7 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
0.00%
0/8 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
3.1%
1/32 • Number of events 1 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
3.4%
1/29 • Number of events 1 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
0.00%
0/7 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
0.00%
0/8 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
|
Vascular disorders
Hospitalization
|
3.1%
1/32 • Number of events 1 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
0.00%
0/29 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
0.00%
0/7 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
0.00%
0/8 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
Other adverse events
| Measure |
Lanthanum Carbonate
n=32 participants at risk
Eligible subjects who are randomly assigned to the experimental arm will receive lanthanum carbonate (1500-4500 mg/day in divided doses) titrated to serum phosphorus levels.
Lanthanum carbonate: Non-calcium containing phosphorus binder
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Placebo
n=29 participants at risk
Eligible subjects who are randomly assigned to the placebo arm will receive placebo tablets (identical to the active lanthanum carbonate tablets) to be taken 3 times daily and titrated to serum phosphorus levels.
placebo: Table identical to lanthanum carbonate but with no active ingredient
Ascorbic Acid: Intravenous administration during measurement of flow mediated dilation.
Nitroglycerin: Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
Flow-mediated dilation measurement: Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
Aortic pulse-wave velocity: Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
Endothelial cell collection: Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
|
Lanthanum Carbonate- Phosphorus Balance Sub-study
n=7 participants at risk
Continued randomized intervention from Parent/Main Study on and received a fixed phosphorus diet for 9 days after the completion of the Parent/Main Study.
|
Placebo- Phosphorus Balance Sub-study
n=8 participants at risk
Continued randomized intervention from Parent/Main Study on and received a fixed phosphorus diet for 9 days after the completion og the Parent/Main Study.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Non-serious adverse events
|
37.5%
12/32 • Number of events 19 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
13.8%
4/29 • Number of events 4 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
0.00%
0/7 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
0.00%
0/8 • 12 weeks (i.e., study duration for each participant in the Main/Parent Study); 9 days (i.e., study duration of Phosphorus Balance Sub-study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place