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| ID | Type | Description | Link |
|---|---|---|---|
| CX001030 | Other Grant/Funding Number | VA |
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The proposed research is a randomized-controlled trial to determine the effectiveness of reducing serum phosphorus using a phosphate binder, lanthanum carbonate, for improving the function of arteries in adults with moderate to severe chronic kidney disease (CKD). [COMIRB 13-0328] Additionally, it will determine phosphorus balance among adults with CKD and whether there is a difference in phosphorus balance after three months of treatment with lanthanum carbonate. [COMIRB 15-0384]
Chronic kidney disease (CKD) is a major health concern both in the general and Veteran populations. Indeed, the prevalence of CKD in a large Veteran population is 20%. Cardiovascular disease (CVD) is significantly increased in CKD and is an important cause of morbidity and mortality. As much as 80% of all CVD is associated with vascular dysfunction, particularly impaired endothelium-dependent dilation (EDD), measured by brachial artery flow-mediate dilation (FMD), and stiffening of the large elastic arteries, measured by aortic pulse-wave velocity (aPWV). Not surprisingly, patients with CKD demonstrate these dysfunctional vascular phenotypes. Even in early stages of CKD, there is an increase in oxidative stress resulting in structural and functional vascular changes, which, in turn, contributes to vascular dysfunction (impaired EDD and large elastic artery stiffening). In CKD, phosphorus remains within the normal range (2.5-4.5 mg/dL) until late in the disease. However, elevated serum phosphorus, even within the normal range, is associated with impaired EDD and with indirect measures of arterial stiffness. Whether lowering serum phosphorus in patients with CKD will improve EDD and arterial stiffness is unknown. This study is a randomized-controlled trial of lanthanum carbonate, a non-calcium based phosphate binder, to treat vascular dysfunction. The efficacy of phosphate binding with lanthanum carbonate for treating vascular endothelial dysfunction and large elastic artery stiffness in patients with stage IIIb and IV CKD (estimated glomerular filtration rate 15-45 mL/min/1.73m2) with baseline serum phosphorus of 2.8-5.5 mg/dL will be assessed. The study will also determine if lowering serum phosphorus with lanthanum carbonate also reduces circulating and endothelial cell markers of oxidative stress. This study could shift clinical practice guidelines by establishing a novel therapy for reducing CVD risk in CKD patients not requiring chronic hemodialysis. [COMIRB 13-0328]
Little is known about phosphorus balance in CKD. It is assumed that CKD patients remain in neutral phosphorus balance despite decreases in kidney function. Serum phosphorus remains in the normal range until late in CKD thus making it difficult to recognize perturbations in phosphorus balance. Indeed, among CKD patients treated with the non-calcium containing phosphate binder, sevelamer, serum phosphorus did not change after six weeks of treatment but urinary phosphate excretion, parathyroid hormone, and fibroblast growth factor-23 changed significantly, suggesting a shift in phosphorus homeostasis. However, two other studies found that patients with CKD III-IV treated with calcium-containing phosphate binders remained in neutral phosphorus balance. There are no studies evaluating the effects of non-calcium based phosphate binders on phosphorus balance among patients with CKD nor other studies examining the effect of changing phosphorus balance on vascular function.
An extension of the above-described 12-week prospective randomized, placebo-controlled double-blind trial (COMIRB 13-0328) will be conducted in a subset of subjects. A total of 24 subjects from COMIRB 13-0328 will be recruited to participate in the Phosphorus Balance sub-investigation (12 subjects treated with lanthanum carbonate and 12 subjects treated with placebo). [15-0384] They will consume a diet with a fixed phosphorus content (1000 +/- 50 mg) for seven days. They will then be admitted to the inpatient Center for Translational Clinical Research at the University of Colorado Denver for 48 hours to accurately collect urine and stool samples. The goal of the Phosphorus Balance sub-investigation (COMIRB 15-0384) is to determine whether lowering serum phosphorus, accomplished during the parent phosphorus lowering randomized-controlled trial (COMIRB 13-0328), affects phosphorus balance compared to those subjects treated with placebo. A key secondary goal is to determine if differences in phosphorus balance affect vascular function as measured by FMD. [15-0384]
To ensure adequate enrollment in the Phosphorus Balance Study (COMIRB 15-0384), an amendment was approved to recruit patients with stage IIIb and IV CKD with normal or modestly elevated serum phosphorus (2.8-5.5 mg/dL) who are not currently participating in the parent Phosphorus Lowering RCT (COMIRB 13-0328). Similar to the Phosphorus Lowering RCT, these patients will follow a low phosphorus diet and will be randomized to lanthanum carbonate or placebo for 12 weeks (run-in period) prior to beginning the current Phosphorus Balance protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lanthanum carbonate | Experimental | 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. |
|
| placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum carbonate | Drug | Non-calcium containing phosphorus binder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna J Jovanovich, MD | Rocky Mountain Regional VA Medical Center, Aurora, CO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38781013 | Derived | Jovanovich A, Struemph T, You Z, Wang W, Farmer-Bailey H, Bispham N, Levi M, Schwartz GG, Nowak KL, Chonchol M. Effect of Lanthanum Carbonate on Serum Phosphate, Oxidative Stress, and Vascular Dysfunction in CKD: A Mechanistic Randomized Controlled Trial. Kidney360. 2024 Jul 1;5(7):959-966. doi: 10.34067/KID.0000000000000465. Epub 2024 May 23. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main/Parent Study |
| |||||||||||||
| Balance Sub-study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants were analyzed if they had baseline and end-of-study FMD measurements and the measurements were of sufficient quality to be analyzed. | Posted | Mean | Standard Deviation | percent change FMD | baseline and 12 weeks |
|
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)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Hepatobiliary disorders | Systematic Assessment | Hospitalization for hepatic encephalopathy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-serious adverse events | Gastrointestinal disorders | Systematic Assessment | Constipation, diarrhea, nausea, vomiting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anna Jovanovich, MD | Rocky Mountain VA Medical Center | 303-724-8677 | anna.jovanovich@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2017 | Aug 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D002318 | Cardiovascular Diseases |
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
| D001205 | Ascorbic Acid |
| D005996 | Nitroglycerin |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| placebo | Drug | Table identical to lanthanum carbonate but with no active ingredient |
|
| Ascorbic Acid | Drug | Intravenous administration during measurement of flow mediated dilation. |
|
|
| Nitroglycerin | Drug | Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation. |
|
| Flow-mediated dilation measurement | Procedure | Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound. |
|
| Aortic pulse-wave velocity | Procedure | 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 | Procedure | 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. |
|
| 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 |
| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | 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. | Participants were included if they had baseline and end of study aPWV measurements and aPWV measurements were of sufficient quality to be analyzed. | Posted | Mean | Standard Deviation | change in aPWV, cm/s | baseline and 12 weeks |
|
|
|
| Primary | Phosphorus Balance Sub-study (COMIRB 15-0384) | Balance is defined as oral intake minus urine output minus stool output. | Subjects who participated in the Phosphorus Balance sub-study and had sufficient stool volume for analysis. | Posted | Mean | Standard Deviation | mg/d | 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. | 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. | Posted | Mean | Standard Deviation | percent change in FMD | baseline and 12 weeks |
|
|
|
| Secondary | 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. | Participants with sufficient number of collected endothelial cells for analysis. | Posted | Mean | Standard Deviation | ratio | baseline and 12 weeks |
|
|
|
| Secondary | 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. | Participants were included if they had baseline and end of study blood collected. | Posted | Median | Inter-Quartile Range | pg/ml | baseline and 12 weeks |
|
|
|
| Secondary | 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. | Participants were included if they had blood collected at baseline and end of study. | Posted | Median | Inter-Quartile Range | mU/ml | baseline and 12 weeks |
|
|
|
| Secondary | 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. | Participants were included if they had baseline and end of study blood collected. | Posted | Median | Inter-Quartile Range | mg/ml | baseline and 12 weeks |
|
|
|
| 1 |
| 32 |
| 3 |
| 32 |
| 12 |
| 32 |
| EG001 | 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. | 0 | 29 | 1 | 29 | 4 | 29 |
| EG002 | Lanthanum Carbonate- Phosphorus Balance Sub-study | 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. | 0 | 7 | 0 | 7 | 0 | 7 |
| EG003 | Placebo- Phosphorus Balance Sub-study | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hospitalization for pneumonia. |
|
| Hospitalization | Vascular disorders | Systematic Assessment | Hospitalization for cerebral vascular accident (CVA) (i.e., stroke). |
|
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D009574 | Nitro Compounds |
| baseline FMD after ascorbic acid |
|
|
| week 12 FMD |
|
|
| week 12 FMD w/ ascorbic acid |
|
|