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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
Sponsor:
Information provided by (Responsible Party):
Alan Yu, MB, BChir, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE May 14, 2014
First Posted Date  ICMJE May 16, 2014
Last Update Posted Date December 1, 2016
Study Start Date  ICMJE May 2014
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2014)
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))
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease
Official Title  ICMJE Uncontrolled, Open Label, Pilot and Feasibility Study of Niacinamide in Polycystic Kidney Disease
Brief Summary 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Polycystic Kidney Disease
Intervention  ICMJE Dietary Supplement: Niacinamide
Other Name: Vitamin B3
Study Arms  ICMJE 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.
Intervention: Dietary Supplement: Niacinamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2016)
10
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2014)
15
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02140814
Other Study ID Numbers  ICMJE STUDY00000874
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alan Yu, MB, BChir, University of Kansas Medical Center
Study Sponsor  ICMJE Alan Yu, MB, BChir
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alan S Yu, MB, BChir University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP