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| ID | Type | Description | Link |
|---|---|---|---|
| 1U54GM104940 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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The proposed randomized controlled trial will test the safety and efficacy of combination therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among patients with chronic kidney disease.
The proposed randomized controlled trial will test the safety and efficacy of combination therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among patients with chronic kidney disease. Investigators will recruit 70 albuminuric CKD patients and randomly assign participants to combination therapy with sodium nitrite and isoquercetin or placebo for three months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | Immediate release sodium nitrite 40 mg by mouth twice per day and Isoquercetin 225 mg by mouth once per day. |
|
| Placebos | Placebo Comparator | identical placebos. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate release sodium nitrite | Drug | Immediate release sodium nitrite 40 mg by mouth twice per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage Change in Endothelium-dependent Flow-mediated Vasodilation (FMD) Over 12 Weeks | FMD was measured using high resolution ultrasound on the brachial artery. FMD was calculated as the maximal percentage change in vessel size during hyperemia . The mean changes between baseline, 6 weeks and 12 weeks in FMD with 95% CI were calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Endothelial Function Biomarkers VCAM-1, ICAM-1, E-selectin and vWF Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of Vascular Adhesion Molecule-1(VCAM-1), Intercellular Adhesion Molecule-1 (ICAM-1), E-selectin, and von Willebrand Factor (vWF). The mean changes between baseline, 6 weeks and 12 weeks in VCAM-1, ICAM-1, E-selectin and vWF with 95% CI were calculated using linear mixed effects model. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage Change in Methemoglobin Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of methemoglobin. The mean percentage change between baseline, 6 weeks and 12 weeks in methemoglobin with 95% CI was calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
participant eligibility is based on self-representation of gender identity.
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| Name | Affiliation | Role |
|---|---|---|
| Jing Chen, MD | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane School of Medicine | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37916745 | Derived | Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3. | |
| 33023894 | Derived | Chen J, Hamm LL, Bundy JD, Kumbala DR, Bodana S, Chandra S, Chen CS, Starcke CC, Guo Y, Schaefer CM, Lustigova E, Mahone E, Vadalia AM, Livingston T, Obst K, Hernandez J, Bokhari SR, Kleinpeter M, Alper AB, Lukitsch I, He H, Nieman DC, He J. Combination Treatment with Sodium Nitrite and Isoquercetin on Endothelial Dysfunction among Patients with CKD: A Randomized Phase 2 Pilot Trial. Clin J Am Soc Nephrol. 2020 Nov 6;15(11):1566-1575. doi: 10.2215/CJN.02020220. Epub 2020 Oct 6. |
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deidentified data sets may be available to other researchers.
no end date.
The de-identified patient level data will be provided directly to the researcher in a secure manner, and the researcher is responsible for protecting the confidentiality and integrity of the data while the research is conducted.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Immediate release sodium nitrite 40 mg by mouth twice per day and Isoquercetin 225 mg by mouth once per day. Immediate release sodium nitrite: Immediate release sodium nitrite 40 mg by mouth twice per day Isoquercetin: Isoquercetin 225 mg by mouth once per day |
| FG001 | Placebos | identical placebos. placebos: placebos |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Immediate release sodium nitrite 40 mg by mouth twice per day and Isoquercetin 225 mg by mouth once per day. Immediate release sodium nitrite: Immediate release sodium nitrite 40 mg by mouth twice per day Isoquercetin: Isoquercetin 225 mg by mouth once per day |
| BG001 | Placebos |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Percentage Change in Endothelium-dependent Flow-mediated Vasodilation (FMD) Over 12 Weeks | FMD was measured using high resolution ultrasound on the brachial artery. FMD was calculated as the maximal percentage change in vessel size during hyperemia . The mean changes between baseline, 6 weeks and 12 weeks in FMD with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | Percentage change | Baseline, 6 weeks, 12 weeks |
|
Each participant was assessed for adverse events in the duration of 3 months.
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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 | Treatment | Immediate release sodium nitrite 40 mg by mouth twice per day and Isoquercetin 225 mg by mouth once per day. Immediate release sodium nitrite: Immediate release sodium nitrite 40 mg by mouth twice per day Isoquercetin: Isoquercetin 225 mg by mouth once per day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious Adverse Event - Inpatient hospitalization | Cardiac disorders | Systematic Assessment | One SAE in the treatment group included a hospitalization for new onset atrial fibrillation due to a massively dilated left atrium. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Events | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jing Chen | Tulane School of Medicine | 5049886110 | jchen@tulane.edu |
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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 | Aug 30, 2016 | Dec 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C016527 | isoquercitrin |
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| Isoquercetin | Dietary Supplement | Isoquercetin 225 mg by mouth once per day |
|
|
| placebos | Other | placebos |
|
| Baseline, 6 weeks, 12 weeks |
| Mean Change in Endothelial Function Biomarker Asymmetrical DiMethylArginine (ADMA) Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of Asymmetrical DiMethylArginine (ADMA). The mean changes between baseline, 6 weeks and 12 weeks in ADMA with 95% CI were calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Endothelial Function Biomarker Endostatin Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of endostatin. The mean changes between baseline, 6 weeks and 12 weeks in endostatin with 95% CI were calculated using linear mixed effects model, and the log transformed endostatin was calculated. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Endothelial Function Biomarker Urine Epidermal Growth Factor (UEGF) Over 12 Weeks | A urine sample was taken for each participant to measure the levels of Urine Epidermal Growth Factor (UEGF). The mean changes between baseline, 6 weeks and 12 weeks in UEGF with 95% CI were calculated using linear mixed effects model, and the log transformed Urine EGF/creatinine ratio was calculated. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Inflammatory Biomarker C-Reactive Protein (CRP) Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of C-Reactive Protein (CRP). The mean changes between baseline, 6 weeks and 12 weeks in CRP with 95% CI were calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Inflammatory Biomarkers Tumor Necrosis Factor-α (TNF-a), Interleukin-17 (IL-17), Interleukin-1β (IL-1beta), and Monocyte Chemoattractant Protein-1 (MCP-1) Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of Tumor Necrosis Factor-α (TNF-a), interleukin-17 (IL-17), interleukin-1β (IL-1beta), and Monocyte Chemoattractant Protein-1 (MCP-1). The mean changes between baseline, 6 weeks and 12 weeks in TNF-a, IL-17, IL-1beta, MCP-1 with 95% CI were calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Inflammatory Biomarker Interleukin-6 (IL-6) Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of interleukin-6 (IL-6). The mean changes between baseline, 6 weeks and 12 weeks in interleukin-6 (IL-6) with 95% CI were calculated using linear mixed effects model, and the log transformed IL-6 was calculated. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Oxidative Stress Biomarker Low-density Lipoprotein (LDL) Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of low-density lipoprotein (LDL). The mean changes between baseline, 6 weeks and 12 weeks in LDL with 95% CI were calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Oxidative Stress Biomarker Nitrotyrosine Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of nitrotyrosine. The mean changes between baseline, 6 weeks and 12 weeks in nitrotyrosine with 95% CI were calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Isoquercetin Over 12 Weeks |
A blood sample was drawn for each participant to measure the levels of isoquercetin. The mean changes between baseline, 6 weeks and 12 weeks in isoquercetin with 95% CI were calculated using linear mixed effects model. |
| Baseline, 6 weeks, 12 weeks |
| Mean Change in Plasma Nitrite Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of plasma nitrite. The mean changes between baseline, 6 weeks and 12 weeks in plasma nitrite with 95% CI were calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Estimated-Glomerular Filtration Rate (eGFR) Over 12 Weeks | Estimated-Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation. The equation is GFR = 141 * min(Scr/κ,1)α * max(Scr/κ, 1)-1.209 * 0.993Age * 1.018 [if female] * 1.159 [if black]. Scr is serum creatinine (mg/dL), κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1. The mean changes between baseline, 6 weeks and 12 weeks in eGFR with 95% CI were calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Lipid Profile Biomarkers Total Cholesterol, Low Density Lipoprotein (LDL)-Cholesterol and High Density Lipoprotein (HDL)-Cholesterol Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of total cholesterol, Low Density Lipoprotein (LDL)-cholesterol and High Density Lipoprotein (HDL)-cholesterol. The mean changes between baseline and 12 weeks in total cholesterol, Low Density Lipoprotein (LDL)-cholesterol and High Density Lipoprotein (HDL)-cholesterol with 95% CI were calculated using linear mixed effects model. | Baseline,12 weeks |
| Mean Change in Lipid Profile Biomarker Triglycerides Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of triglycerides. The mean changes between baseline and 12 weeks in triglycerides with 95% CI were calculated using linear mixed effects model, and the log transformed triglyceride was calculated. | Baseline,12 weeks |
| Mean Change in Hemoglobin Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of hemoglobin. The mean changes between baseline, 6 weeks and 12 weeks in hemoglobin with 95% CI were calculated using linear mixed effects model. | baseline, 6 weeks, 12 weeks |
| Mean Change in Plasma Nitrate Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of plasma nitrate. The mean changes between baseline, 6 weeks and 12 weeks in plasma nitrate with 95% CI were calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Urinary Albumin-to-creatinine Ratios Over 12 Weeks | A urine sample was taken for each participant to measure the levels of urinary albumin-to-creatinine ratios. The mean changes between baseline, 6 weeks and 12 weeks in urinary albumin-to-creatinine ratios with 95% CI were calculated using linear mixed effects model, and the log transformed urinary albumin-to-creatinine ratios was calculated. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Blood Pressure Over 12 Weeks | Blood pressure was measured using the OMRON HEM-907 XL BP Monitor per standard protocol by trained and certified research staff. The mean changes between baseline, 6 weeks and 12 weeks in blood pressure with 95% CI were calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
| Mean Change in Pulse Over 12 Weeks | Pulse was measured at the brachial artery per standard protocol by trained and certified research staff. The mean changes between baseline, 6 weeks and 12 weeks in pulse with 95% CI were calculated using linear mixed effects model. | Baseline, 6 weeks, 12 weeks |
identical placebos. placebos: placebos |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Baseline Characteristics of Study Participants by Treatment Allocation | Number | participants |
|
| Baseline Metabolic Panel of Study Participants by Treatment Allocation | Mean | Standard Deviation | mg/dL |
|
| Baseline Blood Pressure of Study Participants by Treatment Allocation | Mean | Standard Deviation | mmHg |
|
| Baseline Body Mass Index of Study Participants by Treatment Allocation | Mean | Standard Deviation | kg/m^2 |
|
| Baseline Estimated Glomerular Filtration Rate of Study Participants by Treatment Allocation | Mean | Standard Deviation | ml/min/1.73m^2 |
|
| OG001 |
| Placebos |
identical placebos. placebos: placebos |
|
|
| Secondary | Mean Change in Endothelial Function Biomarkers VCAM-1, ICAM-1, E-selectin and vWF Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of Vascular Adhesion Molecule-1(VCAM-1), Intercellular Adhesion Molecule-1 (ICAM-1), E-selectin, and von Willebrand Factor (vWF). The mean changes between baseline, 6 weeks and 12 weeks in VCAM-1, ICAM-1, E-selectin and vWF with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | ng/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Mean Change in Endothelial Function Biomarker Asymmetrical DiMethylArginine (ADMA) Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of Asymmetrical DiMethylArginine (ADMA). The mean changes between baseline, 6 weeks and 12 weeks in ADMA with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | umol/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Mean Change in Endothelial Function Biomarker Endostatin Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of endostatin. The mean changes between baseline, 6 weeks and 12 weeks in endostatin with 95% CI were calculated using linear mixed effects model, and the log transformed endostatin was calculated. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | log (ng/mL) | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Mean Change in Endothelial Function Biomarker Urine Epidermal Growth Factor (UEGF) Over 12 Weeks | A urine sample was taken for each participant to measure the levels of Urine Epidermal Growth Factor (UEGF). The mean changes between baseline, 6 weeks and 12 weeks in UEGF with 95% CI were calculated using linear mixed effects model, and the log transformed Urine EGF/creatinine ratio was calculated. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | log (pg/g) | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Mean Change in Inflammatory Biomarker C-Reactive Protein (CRP) Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of C-Reactive Protein (CRP). The mean changes between baseline, 6 weeks and 12 weeks in CRP with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | mg/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Mean Change in Inflammatory Biomarkers Tumor Necrosis Factor-α (TNF-a), Interleukin-17 (IL-17), Interleukin-1β (IL-1beta), and Monocyte Chemoattractant Protein-1 (MCP-1) Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of Tumor Necrosis Factor-α (TNF-a), interleukin-17 (IL-17), interleukin-1β (IL-1beta), and Monocyte Chemoattractant Protein-1 (MCP-1). The mean changes between baseline, 6 weeks and 12 weeks in TNF-a, IL-17, IL-1beta, MCP-1 with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | pg/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Mean Change in Inflammatory Biomarker Interleukin-6 (IL-6) Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of interleukin-6 (IL-6). The mean changes between baseline, 6 weeks and 12 weeks in interleukin-6 (IL-6) with 95% CI were calculated using linear mixed effects model, and the log transformed IL-6 was calculated. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | log (pg/mL) | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Mean Change in Oxidative Stress Biomarker Low-density Lipoprotein (LDL) Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of low-density lipoprotein (LDL). The mean changes between baseline, 6 weeks and 12 weeks in LDL with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | ng/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Secondary | Mean Change in Oxidative Stress Biomarker Nitrotyrosine Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of nitrotyrosine. The mean changes between baseline, 6 weeks and 12 weeks in nitrotyrosine with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | pg/mL | Baseline, 6 weeks, 12 weeks |
|
|
|
| Other Pre-specified | Mean Percentage Change in Methemoglobin Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of methemoglobin. The mean percentage change between baseline, 6 weeks and 12 weeks in methemoglobin with 95% CI was calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | Percentage change | Baseline, 6 weeks, 12 weeks |
|
|
|
| Other Pre-specified | Mean Change in Isoquercetin Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of isoquercetin. The mean changes between baseline, 6 weeks and 12 weeks in isoquercetin with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | ug/L | Baseline, 6 weeks, 12 weeks |
|
|
|
| Other Pre-specified | Mean Change in Plasma Nitrite Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of plasma nitrite. The mean changes between baseline, 6 weeks and 12 weeks in plasma nitrite with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | micromol/L | Baseline, 6 weeks, 12 weeks |
|
|
|
| Other Pre-specified | Mean Change in Estimated-Glomerular Filtration Rate (eGFR) Over 12 Weeks | Estimated-Glomerular Filtration Rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation. The equation is GFR = 141 * min(Scr/κ,1)α * max(Scr/κ, 1)-1.209 * 0.993Age * 1.018 [if female] * 1.159 [if black]. Scr is serum creatinine (mg/dL), κ is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1. The mean changes between baseline, 6 weeks and 12 weeks in eGFR with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | mL/min/1.73 m^2 | Baseline, 6 weeks, 12 weeks |
|
|
|
| Other Pre-specified | Mean Change in Lipid Profile Biomarkers Total Cholesterol, Low Density Lipoprotein (LDL)-Cholesterol and High Density Lipoprotein (HDL)-Cholesterol Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of total cholesterol, Low Density Lipoprotein (LDL)-cholesterol and High Density Lipoprotein (HDL)-cholesterol. The mean changes between baseline and 12 weeks in total cholesterol, Low Density Lipoprotein (LDL)-cholesterol and High Density Lipoprotein (HDL)-cholesterol with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | mg/dL | Baseline,12 weeks |
|
|
|
| Other Pre-specified | Mean Change in Lipid Profile Biomarker Triglycerides Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of triglycerides. The mean changes between baseline and 12 weeks in triglycerides with 95% CI were calculated using linear mixed effects model, and the log transformed triglyceride was calculated. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | log (mg/dL) | Baseline,12 weeks |
|
|
|
| Other Pre-specified | Mean Change in Hemoglobin Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of hemoglobin. The mean changes between baseline, 6 weeks and 12 weeks in hemoglobin with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | g/dL | baseline, 6 weeks, 12 weeks |
|
|
|
| Other Pre-specified | Mean Change in Plasma Nitrate Over 12 Weeks | A blood sample was drawn for each participant to measure the levels of plasma nitrate. The mean changes between baseline, 6 weeks and 12 weeks in plasma nitrate with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | umol/L | Baseline, 6 weeks, 12 weeks |
|
|
|
| Other Pre-specified | Mean Change in Urinary Albumin-to-creatinine Ratios Over 12 Weeks | A urine sample was taken for each participant to measure the levels of urinary albumin-to-creatinine ratios. The mean changes between baseline, 6 weeks and 12 weeks in urinary albumin-to-creatinine ratios with 95% CI were calculated using linear mixed effects model, and the log transformed urinary albumin-to-creatinine ratios was calculated. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | log (mg/g) | Baseline, 6 weeks, 12 weeks |
|
|
|
| Other Pre-specified | Mean Change in Blood Pressure Over 12 Weeks | Blood pressure was measured using the OMRON HEM-907 XL BP Monitor per standard protocol by trained and certified research staff. The mean changes between baseline, 6 weeks and 12 weeks in blood pressure with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline, 6 weeks, 12 weeks |
|
|
|
| Other Pre-specified | Mean Change in Pulse Over 12 Weeks | Pulse was measured at the brachial artery per standard protocol by trained and certified research staff. The mean changes between baseline, 6 weeks and 12 weeks in pulse with 95% CI were calculated using linear mixed effects model. | Mean Changes Over 12 Weeks (95% CI) | Posted | Mean | 95% Confidence Interval | beat/minute | Baseline, 6 weeks, 12 weeks |
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| 11 |
| 35 |
| EG001 | Placebos | identical placebos. placebos: placebos | 0 | 35 | 1 | 35 | 14 | 35 |
|
Not provided
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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 |
| E-Selecint, ng/mL |
|
| vWF, ng/mL |
|
| IL-1 beta, pg/mL |
|
| MCP-1, pg/mL |
|
| HDL-cholesterol, mg/dL |
|