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

NCT02558595 | Completed Phase 2 DMC

• 2 other identifiers: STUDY00002827R21DK104086
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Kidney Disease

Keywords

PKD; Kidney disease; Vitamin B3

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in height-adjusted total kidney volume

  Change from Baseline to Month 12

• Change in score on pain questionnaire

  Change from Baseline to Month 12

• Change in urinary concentration of MCP-1

  Change from Baseline to Month 12

• Change in estimated GFR

  Change from Baseline to Month 12

Study Arms (2)

Niacinamide

EXPERIMENTAL

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

Dietary Supplement: Niacinamide

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Niacinamide DIETARY_SUPPLEMENT

Also known as: Nicotinamide, Vitamin B3

Niacinamide

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

  PMID: 39356039 DERIVED

MeSH Terms

Conditions

Polycystic Kidney Diseases; Kidney Diseases

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Kidney Diseases, Cystic; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Alan Yu, M.B., B.Chir

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 24, 2015
• Study Start: September 22, 2015
• Primary Completion: December 18, 2017
• Study Completion: December 18, 2017
• Last Updated: February 11, 2019

Record last verified: 2019-02

Locations

US (1)