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Completed

NCT Number: NCT02558595

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

The purpose of this study is to observe the effects of niacinamide on markers of kidney injury, inflammation, kidney cyst growth and kidney function.

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Key information

Conditions

Polycystic Kidney Disease Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Niacinamide

Dietary Supplement

Other names: Nicotinamide, Vitamin B3

Placebo

Other

Placebo pill that matches niacinamide pill is size, shape and color

Primary outcomes

  1. 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 outcomes

  1. Change in height-adjusted total kidney volume

    Time frame: Change from Baseline to Month 12

    Measured by MRI

  2. 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)

  3. Change in urinary concentration of MCP-1

    Time frame: Change from Baseline to Month 12

  4. Change in estimated GFR

    Time frame: Change from Baseline to Month 12

    Determined from serum creatinine concentrations using CKD-Epi equation

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney Disease

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 24, 2015
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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