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

Primary Purpose

Polycystic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Niacinamide
Placebo
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Polycystic Kidney Disease focused on measuring PKD, Kidney disease, Vitamin B3

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Niacinamide

Placebo

Arm Description

Participants will be asked to take niacinamide at a dose of 30 mg/kg/d orally.

Participants will be asked to take a placebo pill at a dose of 30 mg/kg/d orally.

Outcomes

Primary Outcome Measures

Change in acetylated/total p53 ratio measured by ELISA in peripheral blood mononuclear cells (PBMC)
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

Change in height-adjusted total kidney volume
Measured by MRI
Change in score on pain questionnaire
PKD-9 Pain Questionnaire: Range of scores from 13 (no pain or symptoms) to 70 (very severe symptoms almost every day)
Change in urinary concentration of MCP-1
Change in estimated GFR
Determined from serum creatinine concentrations using CKD-Epi equation

Full Information

First Posted
September 21, 2015
Last Updated
February 8, 2019
Sponsor
University of Kansas Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02558595
Brief Title
Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)
Official Title
Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 22, 2015 (Actual)
Primary Completion Date
December 18, 2017 (Actual)
Study Completion Date
December 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Kidney Disease
Keywords
PKD, Kidney disease, Vitamin B3

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Niacinamide
Arm Type
Experimental
Arm Description
Participants will be asked to take niacinamide at a dose of 30 mg/kg/d orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be asked to take a placebo pill at a dose of 30 mg/kg/d orally.
Intervention Type
Dietary Supplement
Intervention Name(s)
Niacinamide
Other Intervention Name(s)
Nicotinamide, Vitamin B3
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo pill that matches niacinamide pill is size, shape and color
Primary Outcome Measure Information:
Title
Change in acetylated/total p53 ratio measured by ELISA in peripheral blood mononuclear cells (PBMC)
Description
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.
Time Frame
Change from Baseline to Month 12
Secondary Outcome Measure Information:
Title
Change in height-adjusted total kidney volume
Description
Measured by MRI
Time Frame
Change from Baseline to Month 12
Title
Change in score on pain questionnaire
Description
PKD-9 Pain Questionnaire: Range of scores from 13 (no pain or symptoms) to 70 (very severe symptoms almost every day)
Time Frame
Change from Baseline to Month 12
Title
Change in urinary concentration of MCP-1
Time Frame
Change from Baseline to Month 12
Title
Change in estimated GFR
Description
Determined from serum creatinine concentrations using CKD-Epi equation
Time Frame
Change from Baseline to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Yu, M.B., B.Chir
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States

12. IPD Sharing Statement

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

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