Try our beta test site
Trial record 11 of 937 for:    nicotinamide

Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by University of Kansas Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Alan Yu, MB, BChir, University of Kansas Medical Center Identifier:
First received: September 21, 2015
Last updated: November 30, 2016
Last verified: November 2016
The purpose of this study is to observe the effects of niacinamide on markers of kidney injury, inflammation, kidney cyst growth and kidney function.

Condition Intervention Phase
Polycystic Kidney Disease
Dietary Supplement: Niacinamide
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:

Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 36
Study Start Date: September 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Niacinamide
Participants will be asked to take niacinamide at a dose of 30 mg/kg/d orally.
Dietary Supplement: Niacinamide
Other Names:
  • Nicotinamide
  • Vitamin B3
Placebo Comparator: Placebo
Participants will be asked to take a placebo pill at a dose of 30 mg/kg/d orally.
Other: Placebo
Placebo pill that matches niacinamide pill is size, shape and color

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed diagnosis of autosomal dominant polycystic kidney disease (ADPKD).
  • Estimated glomerular filtration rate (eGFR) > 50 ml/min/1.73m2 as determined from the serum creatinine by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
  • Provide Informed consent

Exclusion Criteria:

  • History of liver disease or abnormal liver function test
  • Heavy alcohol intake
  • Chronic diarrhea or malabsorption syndrome
  • Thrombocytopenia
  • Hypophosphatemia
  • Pregnancy or lactation or plan to become pregnant during the study
  • Treatment with anti-epileptic drugs
  • Treatment with tolvaptan, current or within 2 months prior to screening
  • Participation in another interventional trial currently or within 2 months prior to screening.

Exclusions specific to magnetic resonance (MR) imaging acquisition and measurement:

  • Partial or total nephrectomy or renal cyst reduction (including aspiration) done <1 year ago
  • Cardiac pacemaker.
  • Presence of MR incompatible metallic clips (e.g. clipped cerebral aneurysm)
  • Body weight >159 kg (350 lbs) or untreatable claustrophobia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02558595

Contact: Cathy Creed, RN, BSN 913-588-0053

United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Alan Yu, M.B., B.Chir University of Kansas Medical Center
  More Information

Responsible Party: Alan Yu, MB, BChir, Professor of Medicine, University of Kansas Medical Center Identifier: NCT02558595     History of Changes
Other Study ID Numbers: STUDY00002827
R21DK104086 ( US NIH Grant/Contract Award Number )
Study First Received: September 21, 2015
Last Updated: November 30, 2016

Keywords provided by University of Kansas Medical Center:
Kidney disease
Vitamin B3

Additional relevant MeSH terms:
Nicotinic Acids
Kidney Diseases
Polycystic Kidney Diseases
Urologic Diseases
Kidney Diseases, Cystic
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents processed this record on March 24, 2017