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Completed

NCT Number: NCT02701127

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oral niacinamide, 1 gram daily

Drug

Oral niacinamide, 3 gram daily

Drug

Placebo

Drug

Primary outcomes

  1. Changes from baseline in serum metabolite profile of niacinamide

    Time frame: Baseline and days 1 through 4

Secondary outcomes

  1. Changes from baseline in urine metabolite profile of niacinamide

    Time frame: Baseline and days 1 through 4

Other outcomes

  1. Adverse events

    Time frame: From enrollment through day 4, and at day 30

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 8, 2016
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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