Trial record 11 of 384 for:    nicotinamide

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by University of Kansas Medical Center
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Alan Yu, MB, BChir, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT02558595
First received: September 21, 2015
Last updated: April 12, 2016
Last verified: April 2016
  Purpose
The purpose of this study is to observe the effects of niacinamide on markers of kidney injury, inflammation, kidney cyst growth and kidney function.

Condition Intervention Phase
Polycystic Kidney Disease
Dietary Supplement: Niacinamide
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Randomized, Controlled Pilot Study of Niacinamide in Polycystic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Change in acetylated/total p53 ratio measured by ELISA in peripheral blood mononuclear cells (PBMC) [ Time Frame: Change from Baseline to Month 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in height-adjusted total kidney volume [ Time Frame: Change from Baseline to Month 12 ] [ Designated as safety issue: No ]
    Measured by MRI

  • Change in score on pain questionnaire [ Time Frame: Change from Baseline to Month 12 ] [ Designated as safety issue: No ]
    PKD-9 Pain Questionnaire: Range of scores from 13 (no pain or symptoms) to 70 (very severe symptoms almost every day)

  • Change in urinary concentration of MCP-1 [ Time Frame: Change from Baseline to Month 12 ] [ Designated as safety issue: No ]
  • Change in estimated GFR [ Time Frame: Change from Baseline to Month 12 ] [ Designated as safety issue: No ]
    Determined from serum creatinine concentrations using CKD-Epi equation


Estimated Enrollment: 36
Study Start Date: September 2015
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Niacinamide
Participants will be asked to take niacinamide at a dose of 30 mg/kg/d orally.
Dietary Supplement: Niacinamide
Other Names:
  • Nicotinamide
  • Vitamin B3
Placebo Comparator: Placebo
Participants will be asked to take a placebo pill at a dose of 30 mg/kg/d orally.
Other: Placebo
Placebo pill that matches niacinamide pill is size, shape and color

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02558595

Contacts
Contact: Cathy Creed, RN, BSN 913-588-0053 CCREED@kumc.edu

Locations
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Alan Yu, M.B., B.Chir University of Kansas Medical Center
  More Information

Responsible Party: Alan Yu, MB, BChir, Professor of Medicine, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02558595     History of Changes
Other Study ID Numbers: STUDY00002827  R21DK104086 
Study First Received: September 21, 2015
Last Updated: April 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas Medical Center:
PKD
Kidney disease
Vitamin B3

Additional relevant MeSH terms:
Niacin
Niacinamide
Nicotinic Acids
Kidney Diseases
Polycystic Kidney Diseases
Kidney Diseases, Cystic
Urologic Diseases
Antimetabolites
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on May 24, 2016