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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oral niacinamide, 1 gram daily
Oral niacinamide, 3 gram daily
Placebo
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Niacinamide 1 gram

Niacinamide 3 grams

Placebo

Arm Description

Oral niacinamide, 1 gram daily

Oral niacinamide, 3 grams daily

Oral placebo pill

Outcomes

Primary Outcome Measures

Changes from baseline in serum metabolite profile of niacinamide

Secondary Outcome Measures

Changes from baseline in urine metabolite profile of niacinamide

Full Information

First Posted
February 29, 2016
Last Updated
March 7, 2018
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02701127
Brief Title
Molecular Effects of Vitamin B3 (Niacinamide) in Acute Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Niacinamide 1 gram
Arm Type
Active Comparator
Arm Description
Oral niacinamide, 1 gram daily
Arm Title
Niacinamide 3 grams
Arm Type
Active Comparator
Arm Description
Oral niacinamide, 3 grams daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo pill
Intervention Type
Drug
Intervention Name(s)
Oral niacinamide, 1 gram daily
Intervention Type
Drug
Intervention Name(s)
Oral niacinamide, 3 gram daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Changes from baseline in serum metabolite profile of niacinamide
Time Frame
Baseline and days 1 through 4
Secondary Outcome Measure Information:
Title
Changes from baseline in urine metabolite profile of niacinamide
Time Frame
Baseline and days 1 through 4
Other Pre-specified Outcome Measures:
Title
Adverse events
Time Frame
From enrollment through day 4, and at day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 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 Age ≥ 18 Signed informed consent Exclusion criteria Pre-existing acute kidney injury Kidney transplantation Off-pump heart surgery Pregnancy End stage renal disease Pregnancy (female subjects of childbearing potential must have a negative serum pregnancy test) 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)
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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