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Trial record 2 of 7352 for:    "Kidney Diseases"

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

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ClinicalTrials.gov Identifier: NCT02558595
Recruitment Status : Active, not recruiting
First Posted : September 24, 2015
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Alan Yu, MB, BChir, University of Kansas Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Polycystic Kidney Disease Dietary Supplement: Niacinamide Other: Placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney Disease
Study Start Date : September 2015
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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

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.

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): NCT02558595


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

Responsible Party: Alan Yu, MB, BChir, Professor of Medicine, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02558595     History of Changes
Other Study ID Numbers: STUDY00002827
R21DK104086 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

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

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