| Trial ID: | L0440 |
| Source ID: | NCT02209636
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| Associated Drug: |
Lanthanum Carbonate
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| Title: |
Phosphate Lowering in CKD Trial
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT02209636/results
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| Conditions: |
Chronic Kidney Disease|Cardiovascular Disease
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| Interventions: |
DRUG: Lanthanum carbonate|DRUG: placebo|DRUG: Ascorbic Acid|DRUG: Nitroglycerin|PROCEDURE: Flow-mediated dilation measurement|PROCEDURE: Aortic pulse-wave velocity|PROCEDURE: Endothelial cell collection
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| Outcome Measures: |
Primary: Brachial Artery Flow-mediated Dilation, 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., baseline and 12 weeks|Aortic Pulse-wave Velocity, 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., baseline and 12 weeks|Phosphorus Balance Sub-study (COMIRB 15-0384), Balance is defined as oral intake minus urine output minus stool output., 9 days from the start of the sub-study, approximately 13 weeks and 2 days from the start of the Main/Parent Study | Secondary: Oxidative Stress-associated Suppression of EDD, 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., baseline and 12 weeks|Vascular Endothelial Cell Protein Expression, 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., baseline and 12 weeks|Interleukin-6 to Measure Systemic Inflammation, 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., baseline and 12 weeks|Oxidized Low-density Lipoprotein (Ox-LDL) to Measure Systemic Oxidized Stress, 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., baseline and 12 weeks|C-reactive Protein to Measure Systemic Inflammation, 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., baseline and 12 weeks
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| Sponsor/Collaborators: |
Sponsor: VA Office of Research and Development
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
66
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2014-09-15
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| Completion Date: |
2019-12-20
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| Results First Posted: |
2022-08-26
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| Last Update Posted: |
2022-08-26
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| Locations: |
Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, 80045, United States
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| URL: |
https://clinicaltrials.gov/show/NCT02209636
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