Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD1)
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|ClinicalTrials.gov Identifier: NCT02140814|
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : December 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Kidney Disease||Dietary Supplement: Niacinamide||Phase 2|
Niacinamide is a form of vitamin B3. Vitamin B3 is found in many foods including yeast, meat, fish, milk, eggs, green vegetables, beans, and cereal grains. Recent studies in mice have shown that niacinamide, at high doses, may slow kidney cyst growth from polycystic kidney disease (PKD).
By doing this study, the researchers will determine if a larger, long-term study to test whether niacinamide slows progression of PKD is justified.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||February 2016|
All subjects in this study will take niacinamide at a dose of 30 mg per kilogram of body weight by mouth daily, in two divided daily doses, for 12 months.
Dietary Supplement: Niacinamide
Other Name: Vitamin B3
- Sirtuin deacetylase activity [ Time Frame: Change from Baseline to 12 Months ]Assessed by the level of post-translational modifications of two intracellular markers (1. Acetylated and total p53 protein concentrations, 2. Phosphorylated and total retinoblastoma protein (Rb))
- Sirtuin deacetylase activity [ Time Frame: Change from Baseline to 6 Months ]Assessed by the level of post-translational modifications of two intracellular markers (1. Acetylated and total p53 protein concentrations, 2. Phosphorylated and total retinoblastoma protein (Rb))
- Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 12 Months ]Measurements at each visit using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- Height-adjusted total kidney volumes (htTKV) [ Time Frame: Change from Baseline to 12 Months ]Measurements will be taken from MRI images, and the annual percent change in htTKV will be compared to historical values reported in a separate study of a similar study population.
- Biomarker levels [ Time Frame: 12 Months ]Aliquots of the urine samples from visits to be tested for a panel of biomarkers related to cyst growth compared to baseline levels.
- Subject pain [ Time Frame: Change from Baseline to 12 Months ]Subject feelings collected via abbreviated pain questionnaire. Questionnaire will be used to calculate pain score.
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): NCT02140814
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Alan S Yu, MB, BChir||University of Kansas Medical Center|