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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-22

Study Completion Date

2017-12-18

Brief Summary

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The purpose of this study is to observe the effects of niacinamide on markers of kidney injury, inflammation, kidney cyst growth and kidney function.

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Detailed Description

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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.

Conditions

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Polycystic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Niacinamide

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

Group Type EXPERIMENTAL

Niacinamide

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo pill that matches niacinamide pill is size, shape and color

Interventions

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Niacinamide

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo pill that matches niacinamide pill is size, shape and color

Intervention Type OTHER

Other Intervention Names

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Nicotinamide Vitamin B3

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No