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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK088833 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study will test the hypothesis that uric acid impairs the function of vessels in patients with kidney disease
The purpose of the study is to understand the effect of lowering serum uric acid levels on vascular function in individuals with chronic kidney disease by comparing the effects of:
1) Allopurinol therapy and 2) Placebo.
Patients will receive: 3 month study drug (either allopurinol or placebo), with assessment of serum uric acid levels and vascular function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. |
|
| Allopurinol | Active Comparator | Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allopurinol | Drug | Xanthine oxidase inhibitor- effective at lowering uric acid levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Endothelial Dependent Dilation From Baseline to Week 12 | Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12 | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in C-reactive Protein From Baseline to Week 12 | Baseline and 12 weeks | |
| Change in Serum Interleukin-6 From Baseline to Week 12 | Baseline and 12 weeks | |
| Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Uric Acid Levels From Baseline to Week 12 | Serum uric acid levels were measured both at baseline and after 12 weeks | Baseline and 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Diana Jalal, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado at Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32964203 | Derived | Perrenoud L, Kruse NT, Andrews E, You Z, Chonchol M, Wu C, Ten Eyck P, Zepeda-Orozco D, Jalal D. Uric Acid Lowering and Biomarkers of Kidney Damage in CKD Stage 3: A Post Hoc Analysis of a Randomized Clinical Trial. Kidney Med. 2020 Feb 26;2(2):155-161. doi: 10.1016/j.xkme.2019.11.007. eCollection 2020 Mar-Apr. |
| Label | URL |
|---|---|
| Information about the Recruiting Center | View source |
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De-identified data will be made available to investigators upon request from the PI
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. Placebo: Placebo tablets with no active ingredient |
| FG001 | Allopurinol | Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group. Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. Placebo: Placebo tablets with no active ingredient |
| BG001 |
| 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 | Change in Endothelial Dependent Dilation From Baseline to Week 12 | Change in Endothelial Dependent Dilation measured by Flow Mediated Dilation at baseline and week 12 | Posted | Mean | Standard Deviation | % change | Baseline and 12 weeks |
|
|
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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 | Control | Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function. Placebo: Placebo tablets with no active ingredient |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | One patient died in the allopurinol arm, and it was attributed to a cardiovascular event |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gout | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Diana Jalal | University of Colorado | 3037244867 | diana.jalal@ucdenver.edu |
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| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Other | Placebo tablets with no active ingredient |
|
| Baseline and 12 weeks |
| Change in Oxidized Low Density Lipoprotein From Baseline to Week 12 | Baseline and 12 weeks |
| What is the endothelium? | View source |
| Allopurinol |
Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group. Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
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| Secondary | Change in C-reactive Protein From Baseline to Week 12 | Posted | Mean | Standard Deviation | mg/L | Baseline and 12 weeks |
|
|
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| Secondary | Change in Serum Interleukin-6 From Baseline to Week 12 | Posted | Mean | Standard Deviation | pg/mL | Baseline and 12 weeks |
|
|
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| Secondary | Change in Monocyte Chemotactic Protein-1 From Baseline to Week 12 | -4.7 | Posted | Mean | Standard Deviation | pg/mL | Baseline and 12 weeks |
|
|
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| Secondary | Change in Oxidized Low Density Lipoprotein From Baseline to Week 12 | Posted | Mean | Standard Deviation | u/L | Baseline and 12 weeks |
|
|
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| Other Pre-specified | Change in Serum Uric Acid Levels From Baseline to Week 12 | Serum uric acid levels were measured both at baseline and after 12 weeks | Posted | Mean | Standard Deviation | mg/dL | Baseline and 12 weeks |
|
|
|
| 0 |
| 41 |
| 9 |
| 41 |
| EG001 | Allopurinol | Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group. Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels. | 1 | 39 | 4 | 39 |
|
| GI discomfort | Gastrointestinal disorders |
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| rash | Skin and subcutaneous tissue disorders |
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| Abnormal Liver Function Tests | Hepatobiliary disorders |
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| Thrombocytopenia | Blood and lymphatic system disorders |
|
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| D052801 | Male Urogenital Diseases |