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Trial record 1 of 3 for:    niacinamide polycystic
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Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02140814
First Posted: May 16, 2014
Last Update Posted: December 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alan Yu, MB, BChir, University of Kansas Medical Center
  Purpose
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.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease

Resource links provided by NLM:


Further study details as provided by Alan Yu, MB, BChir, University of Kansas Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 10
Study Start Date: May 2014
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Niacinamide
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Alan Yu, MB, BChir
Investigators
Principal Investigator: Alan S Yu, MB, BChir University of Kansas Medical Center
  More Information

Responsible Party: Alan Yu, MB, BChir, Professor and Director, Kidney Institute, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02140814     History of Changes
Other Study ID Numbers: STUDY00000874
First Submitted: May 14, 2014
First Posted: May 16, 2014
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by Alan Yu, MB, BChir, University of Kansas Medical Center:
PKD
niacinamide
Vitamin B3
Vitamin B

Additional relevant MeSH terms:
Polycystic Kidney Diseases
Niacinamide
Niacin
Nicotinic Acids
Kidney Diseases
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Vitamins
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents