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

Acute Kidney Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701127
• Other study ID #: 2016P000028
• Status: Completed
• Phase: Early Phase 1
• First received: February 29, 2016
• Last updated: March 7, 2018
• Start date: March 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2018
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Drug:
• Oral niacinamide, 1 gram daily

• Oral niacinamide, 3 gram daily

• Placebo

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		From enrollment through day 4, and at day 30
Primary	Changes from baseline in serum metabolite profile of niacinamide		Baseline and days 1 through 4
Secondary	Changes from baseline in urine metabolite profile of niacinamide		Baseline and days 1 through 4