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

Beth Israel Lahey Health

Status and phase: Completed; Early Phase 1

Conditions: Acute Kidney Injury

Treatments: Drug: Placebo; Drug: Oral niacinamide, 3 gram daily; Drug: Oral niacinamide, 1 gram daily

Study type: Interventional

Funder types: Other

Identifiers

NCT02701127

2016P000028

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 3 patient groups, including a placebo group

Niacinamide 1 gram

Active Comparator group

Description:

Oral niacinamide, 1 gram daily

Treatment:

Drug: Oral niacinamide, 1 gram daily

Niacinamide 3 grams

Active Comparator group

Description:

Oral niacinamide, 3 grams daily

Treatment:

Drug: Oral niacinamide, 3 gram daily

Placebo

Placebo Comparator group

Description:

Oral placebo pill

Treatment:

Drug: Placebo