Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)
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|ClinicalTrials.gov Identifier: NCT02558595|
Recruitment Status : Active, not recruiting
First Posted : September 24, 2015
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Kidney Disease||Dietary Supplement: Niacinamide Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney Disease|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
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
- Change in acetylated/total p53 ratio measured by ELISA in peripheral blood mononuclear cells (PBMC) [ Time Frame: Change from Baseline to Month 12 ]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 ]Measured by MRI
- Change in score on pain questionnaire [ Time Frame: Change from Baseline to Month 12 ]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 ]
- Change in estimated GFR [ Time Frame: Change from Baseline to Month 12 ]Determined from serum creatinine concentrations using CKD-Epi equation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02558595
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Alan Yu, M.B., B.Chir||University of Kansas Medical Center|