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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21DK077368-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to obtain information on whether raising levels of HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney disease. This may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niacin | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niacin | Drug | 1000 mg tablets once per day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Flow Mediated Dilation From Baseline | Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks | 14 weeks since baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HDL-C From Baseline to 14 Weeks | 14 weeks since baseline |
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Inclusion Criteria:
Exclusion Criteria:
Hospitalization within prior 3 months
Any of the following conditions:
Nursing
Pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Mark Sarnak, MD | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
There was no washout period. Patients receiving Niacin were excluded from the study.
All patients were recruited at Tufts Medical Center. Dates of recruitment were 9/2008 to 11/2011
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| ID | Title | Description |
|---|---|---|
| FG000 | Niacin | Niacin : 1000 mg tablets once per day |
| FG001 | Placebo | Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
These were the number of individuals who agreed to be randomized for the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Niacin | Niacin : 1000 mg tablets once per day |
| BG001 | Placebo | Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance |
| 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 | Change in the Flow Mediated Dilation From Baseline | Flow mediated dilation by brachial artery reactivity at baseline versus 14 weeks | Posted | Mean | 95% Confidence Interval | absolute percent change | 14 weeks since baseline |
|
|
During the trial up to 14 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 | Niacin | Niacin : 1000 mg tablets once per day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| flushing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Sarnak, MD | Tufts Medical Center | 617 636-1182 | msarnak@tuftsmedicalcenter.org |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Active Placebo | Drug | 100 mg Niacin tablets once per day |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Change in HDL-C From Baseline to 14 Weeks | Posted | Mean | 95% Confidence Interval | mg/dl | 14 weeks since baseline |
|
|
|
|
| 0 |
| 15 |
| 10 |
| 15 |
| EG001 | Placebo | Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance | 0 | 15 | 5 | 15 |
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| joint pains | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |