Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)
Polycystic Kidney Disease
Dietary Supplement: Niacinamide
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
|Official Title:||Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney Disease|
- Change in acetylated/total p53 ratio measured by ELISA in peripheral blood mononuclear cells (PBMC) [ Time Frame: Change from Baseline to Month 12 ] [ Designated as safety issue: No ]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 in height-adjusted total kidney volume [ Time Frame: Change from Baseline to Month 12 ] [ Designated as safety issue: No ]Measured by MRI
- Change in score on pain questionnaire [ Time Frame: Change from Baseline to Month 12 ] [ Designated as safety issue: No ]PKD-9 Pain Questionnaire: Range of scores from 13 (no pain or symptoms) to 70 (very severe symptoms almost every day)
- Change in urinary concentration of MCP-1 [ Time Frame: Change from Baseline to Month 12 ] [ Designated as safety issue: No ]
- Change in estimated GFR [ Time Frame: Change from Baseline to Month 12 ] [ Designated as safety issue: No ]Determined from serum creatinine concentrations using CKD-Epi equation
|Study Start Date:||September 2015|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Participants will be asked to take niacinamide at a dose of 30 mg/kg/d orally.
Dietary Supplement: Niacinamide
Placebo Comparator: Placebo
Participants will be asked to take a placebo pill at a dose of 30 mg/kg/d orally.
Placebo pill that matches niacinamide pill is size, shape and color
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02558595
|Contact: Cathy Creed, RN, BSN||913-588-0053||CCREED@kumc.edu|
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Alan Yu, M.B., B.Chir||University of Kansas Medical Center|