NCT02558595

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

Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Polycystic Kidney Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Niacinamide
OTHER	Placebo	Placebo pill that matches niacinamide pill is size, shape and color

Timeline

• Start date: 2015-09-22
• Primary completion: 2017-12-18
• Completion: 2017-12-18
• First posted: 2015-09-24
• Last updated: 2019-02-11

Locations

1 site across 1 country: United States