Skip to main content
OpenTrials
Completed

NCT Number: NCT02140814

Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease

The goal of this pilot study is to evaluate the feasibility of administering niacinamide to patients with autosomal dominant polycystic kidney disease, to develop methods to assess the biological efficacy of niacinamide, and to perform a preliminary exploration of its clinical effect on kidney cyst growth and kidney function.

Completed

Looking for future studies?

Notify Me

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–50 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

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.

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
  • eGFR > 90ml/min/1.73m2 as determined from the serum creatinine by the CKD-EPI equation
  • Ability to give informed consent in English

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 30 days prior to screening
  • Partial or total nephrectomy or renal cyst reduction (including aspiration) done <1 year ago
  • Cardiac pacemaker
  • Presence of magnetic resonance-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: Vitamin B3

Primary outcomes

  1. 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))

Secondary outcomes

  1. 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))

  2. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: 12 Months

    Measurements at each visit using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Alan Yu, MB, BChir

Other

Registry information

Acronym: NIAC-PKD1

Important dates

Study start
2014
Primary completion
2016
First posted
May 16, 2014
Registry last updated
Dec 1, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.