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| ID | Type | Description | Link |
|---|---|---|---|
| R21DK104086 | 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 observe the effects of niacinamide on markers of kidney injury, inflammation, kidney cyst growth and kidney function.
Polycystic Kidney Disease (PKD) is a genetic disease that affects about 1 in 500 people worldwide. It can lead to kidney failure which can lead to death. PKD causes the development of kidney cysts (fluid-filled balloons), which cause worsening kidney function. It is common for people with PKD to also have blood in the urine, kidney pain, high blood pressure, kidney stones, kidney infections, and cysts in the brain or other parts of the body.
There is currently no treatment known to stop cyst growth or a cure for the disease.
Participants in this study will be randomly assigned to one of two groups: niacinamide or placebo. Participants have an equal chance of being assigned to either of the groups. For people that qualify and decide to participate in this study, they will be asked to make five visits to the study clinic and complete two study related phone calls over the course of 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niacinamide | Experimental | Participants will be asked to take niacinamide at a dose of 30 mg/kg/d orally. |
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| Placebo | Placebo Comparator | Participants will be asked to take a placebo pill at a dose of 30 mg/kg/d orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niacinamide | Dietary Supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in acetylated/total p53 ratio measured by ELISA in peripheral blood mononuclear cells (PBMC) | Sirtuin 1 deacetylates p53 protein, and niacinamide inhibits sirtuin 1. So an increase in acetylated/total p53 ratio in PBMC will be used as a marker of biological efficacy. | Change from Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in height-adjusted total kidney volume | Measured by MRI | Change from Baseline to Month 12 |
| Change in score on pain questionnaire | PKD-9 Pain Questionnaire: Range of scores from 13 (no pain or symptoms) to 70 (very severe symptoms almost every day) |
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Inclusion Criteria:
Exclusion Criteria:
Exclusions specific to magnetic resonance (MR) imaging acquisition and measurement:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Yu, M.B., B.Chir | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39356039 | Derived | St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3. |
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| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D052177 | Kidney Diseases, Cystic |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D009536 | Niacinamide |
| ID | Term |
|---|---|
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
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| Placebo |
| Other |
Placebo pill that matches niacinamide pill is size, shape and color |
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| Change from Baseline to Month 12 |
| Change in urinary concentration of MCP-1 | Change from Baseline to Month 12 |
| Change in estimated GFR | Determined from serum creatinine concentrations using CKD-Epi equation | Change from Baseline to Month 12 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| D006573 |
| Heterocyclic Compounds, 1-Ring |