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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
Risk factors for surgery related to adverse cardiovascular outcomes include one or more of the following: Valve surgery, eGFR < 45 ml/min/1.73m2, Documented LVEF ≤ 35% within six months before surgery, Documented history of heart failure, Insulin-requiring diabetes, Non-insulin-requiring diabetes and the presence of ≥+2 proteinuria on urinalysis (or equivalent on urine protein-to-creatinine ratio or urine albumin-to-creatinine ratio), Preoperative anemia (hemoglobin <11g/dl for men and women), History of prior CABG, Age ≥65
Procedures include: CABG, Aortic, mitral, tricuspid, or pulmonic valve replacement or repair, CABG with aortic, mitral, tricuspid, and/or pulmonic valve replacement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6, 12, 24, and 48 hours post operatively
Awards & highlights

NACAM Trial 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+.Check my eligibility
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.See study design
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.

NACAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have certain health conditions or risk factors that could make surgery risky for your heart, such as heart valve surgery, kidney function below a certain level, weak heart pumping function, history of heart failure, diabetes requiring insulin, diabetes not requiring insulin with certain kidney function test results, low red blood cell count, previous heart bypass surgery, or being 65 years or older.
Select...
I have had heart surgery, including valve repair or replacement.
Select...
I am over 18 and scheduled for heart surgery with CPB, at high risk for heart-related surgery complications.

NACAM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Troponin T AUC
Secondary outcome measures
Mean difference in eGFR
Mean difference in uQuin/Tryp ratio AUC
Other outcome measures
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
100%
Fatigue
89%
Nausea
78%
Anorexia
78%
Diarrhea
67%
Vomitiing
56%
Headaches
56%
Headache
56%
Odor with Urination
44%
Constipation
44%
Fever
44%
Cough
44%
Dyspnea (DOE)
44%
Pain
44%
Flushing
33%
Anxiety
33%
Trace Edema
33%
Chills
33%
Shortness of Breath
33%
Zoster
33%
Upper Respitatory Infections and infestations
33%
Cold
33%
Abdominal Cramping
33%
Edema
33%
Nasal Congestion
33%
Metallic Taste
22%
Tachycardia
22%
Hypotension
22%
Legs Cramps
22%
Chest Pain
22%
Mouth Sore
22%
Pruritic Rash
22%
Sensory Neuropathy in feet
22%
Thrombocytopenia
22%
Weakness
22%
ALT
22%
Anemia
22%
Sore Throat
22%
Dizziness
22%
Insomnia
22%
itching
22%
Neutropenia
22%
Vomiting
22%
AST
11%
Scrotal and Penile Edema
11%
Mild Dyspena
11%
Diffuse Erythematous Rash ( extremeties)
11%
DVT ( Left subclavala vein)
11%
Hypomagnesemia
11%
Cramping (menopausal symptoms)
11%
Hyperactive
11%
Sweating
11%
Liver Dysfunction
11%
Bloodshot eyes
11%
Night Sweats
11%
Pneumonia (Probable)
11%
Stomach Pain
11%
Gagging
11%
Incontinence
11%
Left Hip Pain
11%
Leg Weakness/numbness
11%
Toe Parasthesias
11%
Gums/Teeth tender feeling
11%
Finger Parasthesias
11%
Death
11%
DVT
11%
Hand-Foot Reaction
11%
Leg Weakness & Numbness
11%
Sensory Neuropathy
11%
Soreness in mouth
11%
MSSA
11%
Ammonia
11%
Creatinine
11%
D-Dimer
11%
Epigastric Pain
11%
Hiccups
11%
INR
11%
Neutropenic Spesis
11%
Occasional sweating at night
11%
Rash(blotchy dry spots on hands)
11%
Right Upper Quadrant Pain
11%
Sinus Tachycardia
11%
Throat Tightening
11%
Toe Cramping
11%
Vaginal dryness (menopausal symptoms)
11%
Hives
11%
Upper/Mild Back Spams
11%
Elevated WBC
11%
Sepsis
11%
Bilateral Lower Extremity Edema
11%
Burning near rectum (likely zoster related)
11%
Eschai of ight index finger
11%
Hot flashes
11%
Right Groin Pain
11%
Swollen Hands & Feets
11%
Taste Changes
11%
Upset Stomach
11%
UTI
11%
Wide based gait when walking
11%
Pneumonia
11%
3 Puncatate skin Leasions on Arm(mosquito bites)
11%
Abdominal Discomfort
11%
Abdominal pain
11%
Chest Pressure
11%
Death NOS
11%
Dry Eyes
11%
Dry Skin
11%
Dysuria
11%
Elevated Creatinine
11%
Groin Swelling (post -op site)
11%
Hyperbilirubinemia
11%
Hyperglycemia
11%
Hypoalbuminemia
11%
Hypokalemia
11%
Left Upper Quandrant Pain
11%
Mucositis
11%
Neuropathy
11%
Right Shoulder Muscle Pain
11%
Palpitations
11%
Parasthesia
11%
Rash (mid area of chest)
11%
Right Lower Back Pain
11%
Right Lower Leg Pain
11%
Right rib Pain
11%
Skin tenderness on face
11%
Syncope
11%
T6/7 & T9/10 Cord Compression
11%
Chord Compression
11%
Upper Respiratory Infection
11%
Hand- Foot Reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vorinostat (SAHA) and Niacinamide: Level 4
Vorinostat (SAHA) and Niacinamide: Level 5
Vorinostat, Niacinamide and Etoposide: Level 1
Vorinostat, Niacinamide and Etoposide: Level 2
Vorinostat (SAHA) and Niacinamide: Level 1
Vorinostat (SAHA) and Niacinamide: Level 2
Vorinostat (SAHA) and Niacinamide: Level 3

NACAM 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?

Cedars-Sinai Medical CenterOTHER
497 Previous Clinical Trials
164,255 Total Patients Enrolled
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,024 Total Patients Enrolled
Kaiser PermanenteLead Sponsor
537 Previous Clinical Trials
24,113,032 Total Patients Enrolled

Media Library

Niacinamide (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT04750616 — Phase 2
Myocardial Injury Research Study Groups: Oral niacinamide, Matched placebo
Myocardial 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to join this investigation?

"According to clinicaltrials.gov, this experiment is currently recruiting subjects. The study was initially advertised on September 13th 2021 and the latest update occurred on June 27th 2022."

Answered by AI

To what conditions is Niacinamide typically applied therapeutically?

"Niacinamide is often administered for nutritional supplementation, but it also has clinical applications in dietary and vitamin deficiencies as well as macrocytic anemia."

Answered by AI

What is the enrollment cap for this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this medical trial, which was initially made available on September 13th 2021, is currently enrolling patients . Approximately 304 test subjects need to be recruited from 1 research facility."

Answered by AI

Does the Food and Drug Administration sanction Niacinamide for therapeutic use?

"At Power, we rated Niacinamide's safety as a 2 since there is only data supporting its security but no evidence that it has any therapeutic benefits."

Answered by AI
~92 spots leftby Apr 2025