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The funding source is not going to fund this anymore. Only two subjects completed the study therefore meaningful analysis not possible.
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Patients with kidney failure on hemodialysis have an extremely high rate of cardiovascular disease including atherosclerotic cardiovascular disease. This, at least in part, is due to the chronic inflammatory status usually seen in these patients. Here we try to see if treatment with extended release nicotinic acid (Niaspan) can reduce their overall inflammatory burden (in general) and the atherosclerotic plaque inflammation (in particular).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| This study has only one arm. | Experimental | Blood sample and scan results to be compared before and after intervention in each subject. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Release Nicotinic Acid (Niaspan) | Drug | Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in FDG-PET/CT Dual Scan Score | 6 months | |
| Changes in Hs-CRP Level | Change in hs-CRP level before and after treatment in each subject | 6 months |
| Changes in IL-6 Level | Change in IL-6 level before and after treatment in each subject | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Albumin Level | Pre and Post levels. | 6 months |
| ESA (Erythorpoietic Stimulating Agent) Dose Requirement | Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kambiz ZANDI-NEJAD, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| BWH/FH/DCI Outpatient Dialysis Unit |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group (One Arm Only Study) | Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 6 months |
| Hemoglobin Level | Pre and Post Levels | 6 months |
| Rate of Cardiovascular Events | Comparison of the average major cardiovascular events (myocardial infarction and/or stroke) in the 3 month before and the last 3 months of the study. | 6 months |
| Hemodialysis Access Stenosis/Thrombosis | Comparison of the average hemodialysis access stenosis/thrombosis requiring intervention in the 3 month before and the last 3 months of the study. | 6 months |
| Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase). | The number of subjects with significant rise in ALT but not to the extent requiring removal from the study (rise to more than 3 times the upper limit of the normal range) | 6 months (checked monthly) |
| Boston |
| Massachusetts |
| 02130 |
| United States |
| DCI Dialysis Unit-Somerville | Somerville | Massachusetts | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group (One Arm Only Study) | Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Changes in FDG-PET/CT Dual Scan Score | Analysis of images for this outcome measure was not done given than only 2 subjects had completed the study at the time of the study early termination and closure (per funding source) | Posted | 6 months |
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| Primary | Changes in Hs-CRP Level | Change in hs-CRP level before and after treatment in each subject | Only 2 subjects completed the study. Power for further analysis was not met. | Posted | Mean | Full Range | mg/L | 6 months |
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| Primary | Changes in IL-6 Level | Change in IL-6 level before and after treatment in each subject | Only 2 subjects completed the study. Further analysis not done because power was not met. | Posted | Mean | Full Range | pg/mL | 6 months |
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| Secondary | Albumin Level | Pre and Post levels. | Only 2 subjects completed the study. Further analysis was not done because power was not met. | Posted | Mean | Full Range | g/dL | 6 months |
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| Secondary | ESA (Erythorpoietic Stimulating Agent) Dose Requirement | Comparison of the average ESA dose used in the 3 month before and the last 3 months of the study. | Data for this outcome measure was not collected. | Posted | 6 months |
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| Secondary | Hemoglobin Level | Pre and Post Levels | Only 2 subjects completed the study. Further analysis was not done because power was not met. | Posted | Mean | Full Range | g/dL | 6 months |
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| Secondary | Rate of Cardiovascular Events | Comparison of the average major cardiovascular events (myocardial infarction and/or stroke) in the 3 month before and the last 3 months of the study. | Data for this outcome measure was not collected from the medical record due to early termination of the study. | Posted | 6 months |
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| Secondary | Hemodialysis Access Stenosis/Thrombosis | Comparison of the average hemodialysis access stenosis/thrombosis requiring intervention in the 3 month before and the last 3 months of the study. | Data for this outcome measure was not collected from the medical record due to early termination of the study. | Posted | 6 months |
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| Secondary | Number of Completed Subjects With Significant Increase in ALT (Alanine Aminotransferase). | The number of subjects with significant rise in ALT but not to the extent requiring removal from the study (rise to more than 3 times the upper limit of the normal range) | Posted | Number | Participants | 6 months (checked monthly) |
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6 months (the time between the first and the second scan)
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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 Group (One Arm Only Study) | Blood sample and scan results to be compared before and after intervention in each subject. Extended Release Nicotinic Acid (Niaspan): Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks. | 1 | 22 | 2 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment | One subject with pre-existing atrial fibrillation developed another episode of atrial fibrillation and was taken off the study out of abundance of caution and was reported to IRB. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flushing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| GI upset | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kambiz Zandi-Nejad | Brigham and Women's Hospital | 617-732-6660 | 34769 page | kzandinejad@partners.org |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009525 | Niacin |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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