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

NCT02701127 | Completed Early Phase 1

• 1 other identifier: 2016P000028
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in serum metabolite profile of niacinamide

  Baseline and days 1 through 4

Secondary Outcomes (1)

• Changes from baseline in urine metabolite profile of niacinamide

  Baseline and days 1 through 4

Other Outcomes (1)

• Adverse events

  From enrollment through day 4, and at day 30

Study Arms (3)

Niacinamide 1 gram

ACTIVE COMPARATOR

Oral niacinamide, 1 gram daily

Drug: Oral niacinamide, 1 gram daily

Niacinamide 3 grams

ACTIVE COMPARATOR

Oral niacinamide, 3 grams daily

Drug: Oral niacinamide, 3 gram daily

Placebo

PLACEBO COMPARATOR

Oral placebo pill

Drug: Placebo

Interventions

Oral niacinamide, 1 gram daily DRUG

Niacinamide 1 gram

Oral niacinamide, 3 gram daily DRUG

Niacinamide 3 grams

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Niacinamide

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Medicine

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 8, 2016
• Study Start: March 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: July 1, 2017
• Last Updated: March 8, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)