Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-20 @ 12:57 PM
Study NCT ID:
NCT02558595
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2015-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Niacinamide in Polycystic Kidney Disease (NIAC-PKD2)
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R21DK104086 | NIH | None | https://reporter.nih.gov/quic… | View |