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Vitamin

NAD+ Augmentation for Acute Kidney Injury (NACAM Trial)

Phase 2
Recruiting
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Procedures include: CABG, Aortic, mitral, tricuspid, or pulmonic valve replacement or repair, CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement
Men or women >18 years of age who are scheduled for non-emergent cardiac surgery procedures requiring CPB and are at increased risk for surgery-related adverse cardiovascular outcomes
Must not have
Kidney transplant status
Off-pump cardiac surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6, 12, 24, and 48 hours post operatively

Summary

This trial was designed to study the effectiveness of a drug called Nam for preventing acute kidney injury in patients undergoing heart surgery.

Who is the study for?
This trial is for adults over 18 who need non-emergency heart surgery with a pump and are at high risk of heart-related complications. Eligible participants include those with valve surgeries, weak kidney function, reduced heart pumping capacity, history of heart failure or diabetes, protein in urine, anemia, previous bypass surgery or age 65+.
What is being tested?
The study tests if Niacinamide (a form of vitamin B3) can prevent acute kidney injury after on-pump cardiac surgery compared to a placebo. Participants will be randomly assigned to receive either Niacinamide or a placebo in this double-blind study where neither the patients nor the researchers know who gets which treatment.
What are the potential side effects?
While specific side effects are not listed here, generally Niacinamide may cause mild flushing of the skin, itching or rash; upset stomach; dizziness; and might affect blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had heart surgery, including valve repair or replacement.
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I am over 18 and scheduled for heart surgery with CPB, at high risk for heart-related surgery complications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a kidney transplant.
Select...
I am having heart surgery without using a heart-lung machine.
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My kidney function was reduced before surgery, as shown by a creatinine test.
Select...
I have end-stage renal disease.
Select...
I am currently detained or incarcerated.
Select...
I need urgent heart surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6, 12, 24, and 48 hours post operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6, 12, 24, and 48 hours post operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Troponin T AUC
Secondary study objectives
Mean difference in eGFR
Mean difference in uQuin/Tryp ratio AUC
Other study objectives
Length of index hospital stay.
Length of intensive care unit stay.
Number of Participants with the following Adverse Events and Serious Adverse Events
+3 more

Side effects data

From 2015 Phase 1 trial • 40 Patients • NCT00691210
71%
Nausea
57%
Fatigue
43%
Anorexia
43%
Flushing
29%
Anxiety
29%
Tachycardia
29%
Fever
29%
Hypokalemia
29%
Cough
29%
Vomitiing
29%
Anemia
29%
Edema
14%
MAPS (in 50's)
14%
Hypercalcemia
14%
Aspergillus fumigatus
14%
Zoster
14%
Depression
14%
Elevated Base Excess (intermittent)
14%
Alk Phos
14%
Bacterial SuperInfections and infestations
14%
Bad Taste in Mouth
14%
Collapsed Lung
14%
Heart Palpitations
14%
Hyperbilirubinemia
14%
itching
14%
Left Groin Lymph Node Pain
14%
Papular Rash
14%
Presyncopal Episode
14%
Shortness of Breath
14%
Urea Nitrogen
14%
Chest Pain
14%
Headaches
14%
Gas
14%
Chills
14%
Constipation
14%
Diarrhea
14%
Discomfort in Stomach (pain)
14%
Disseminated Zoster
14%
Hyperactivity of the Gut
14%
Low Chloride (intermittent)
14%
Neutropenic Spesis
14%
Night Sweats
14%
Thrombocytopenia
14%
Belching
14%
Hypoxia
14%
ALT
14%
O2 saturation
14%
Elevated PO2 (intermittent)
14%
Hoarse Voice
14%
Low CO2
14%
Low PCO2 (intermittent)
14%
Low PO2 (intermittent)
14%
Infection
14%
Acute Dyspnea
14%
Headache
14%
AST
14%
Elevated Creatinine
14%
Elevated Lactate
14%
Elevated pH (intermittent)
14%
GERD
14%
Hyperglycemia
14%
Hypoalbuminemia
14%
Hyponatremia
14%
Light Headedness
14%
Neutropenia
14%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vorinostat, Niacinamide and Etoposide: Level 1
Vorinostat (SAHA) and Niacinamide: Level 4
Vorinostat (SAHA) and Niacinamide: Level 5
Vorinostat, Niacinamide and Etoposide: Level 2
Vorinostat (SAHA) and Niacinamide: Level 1
Vorinostat (SAHA) and Niacinamide: Level 2
Vorinostat (SAHA) and Niacinamide: Level 3

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral niacinamideExperimental Treatment1 Intervention
Group II: Matched placeboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niacinamide
2011
Completed Phase 4
~200

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterOTHER
861 Previous Clinical Trials
12,932,522 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
445 Patients Enrolled for Acute Kidney Injury
Cedars-Sinai Medical CenterOTHER
513 Previous Clinical Trials
163,085 Total Patients Enrolled
Kaiser PermanenteLead Sponsor
556 Previous Clinical Trials
27,732,432 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,794,927 Total Patients Enrolled
9 Trials studying Acute Kidney Injury
4,242 Patients Enrolled for Acute Kidney Injury

Media Library

Niacinamide (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT04750616 — Phase 2
Acute Kidney Injury Research Study Groups: Oral niacinamide, Matched placebo
Acute Kidney Injury Clinical Trial 2023: Niacinamide Highlights & Side Effects. Trial Name: NCT04750616 — Phase 2
Niacinamide (Vitamin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04750616 — Phase 2
~28 spots leftby Apr 2025
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