Molecular Effects of Vitamin B3 (Niacinamide) in Acute Kidney Injury

This is a single center, randomized, single-blind, placebo-controlled study to evaluate the safety and biochemical effects of niacinamide on metabolic parameters of the kidney in patients undergoing cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Placebo; Drug: Oral niacinamide, 1 gram daily; Drug: Oral niacinamide, 3 gram daily

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

1. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass at high risk for acute kidney injury. A Cleveland score of 6 or more is used to define patients at high risk for acute kidney injury
2. Age ≥ 18
3. Signed informed consent

Exclusion criteria

1. Pre-existing acute kidney injury
2. Kidney transplantation
3. Off-pump heart surgery
4. Pregnancy
5. End stage renal disease
6. Pregnancy (female subjects of childbearing potential must have a negative serum pregnancy test)
7. Subjects with any kind of dependency on the investigator (e.g. any subject who is under direct supervision of the investigator/co-investigators or employed by the investigator/co-investigators) 8 Subjects held in an institution by legal or official order (e.g. subjects in jail, prison, juvenile offender facility, or treatment facility including those who are in hospitals, alcohol, and drug treatment facilities under court order, and individuals with psychiatric illnesses who have been committed involuntarily to an institution)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Niacinamide 1 gram; Oral niacinamide, 1 gram daily	Drug: Oral niacinamide, 1 gram daily
Active Comparator: Niacinamide 3 grams; Oral niacinamide, 3 grams daily	Drug: Oral niacinamide, 3 gram daily
Placebo Comparator: Placebo; Oral placebo pill	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in serum metabolite profile of niacinamide	Baseline and days 1 through 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in urine metabolite profile of niacinamide	Baseline and days 1 through 4

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events	From enrollment through day 4, and at day 30

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 29, 2016
• First Submitted That Met QC Criteria: March 2, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: 2016P000028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No