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

Polycystic Kidney Disease Clinical Trial

Official title:

Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02558595
• Other study ID #: STUDY00002827
• Secondary ID: R21DK104086
• Status: Completed
• Phase: Phase 2
• Start date: September 22, 2015
• Est. completion date: December 18, 2017

Study information

• Verified date: February 2019
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 18, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Polycystic Kidney Disease
• Polycystic Kidney Diseases

Intervention

Dietary Supplement:
• Niacinamide

Other:
• Placebo
Placebo pill that matches niacinamide pill is size, shape and color

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline to Month 12
Secondary	Change in height-adjusted total kidney volume	Measured by MRI	Change from Baseline to Month 12
Secondary	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 from Baseline to Month 12
Secondary	Change in urinary concentration of MCP-1		Change from Baseline to Month 12
Secondary	Change in estimated GFR	Determined from serum creatinine concentrations using CKD-Epi equation	Change from Baseline to Month 12