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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Acute Kidney Injury

In brief

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.

Key facts

Study ID

NCT02701127

Run by

Beth Israel Deaconess Medical Center

People needed

55

Starts

2016-03-01

Expected to finish

2017-07-01

Last updated by the study team

2018-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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