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Preventing Kidney Injury with Sodium Nitrate

This study is testing if sodium nitrate capsules can help prevent acute kidney injury (AKI), a sudden kidney problem, in people at high risk who are having a coronary angiogram (an X-ray of heart blood vessels) or a CT scan with contrast. You could be eligible if you are 18 or older and have a high risk for AKI based on your kidney function. Participants will receive either sodium nitrate or a placebo (an inactive capsule) before and after their procedure. The study will look at how many participants take the medication as planned and have follow-up blood tests to check kidney function. This is a pilot study to help plan future research.

Study design
This is an interventional study planning to enroll 100 participants. It is a blinded study, meaning neither you nor your doctor will know if you are receiving sodium nitrate or the placebo.
What's involved
You would take a capsule (sodium nitrate or placebo) 1-8 hours before your procedure and then once daily for a total of four doses. You will also have a blood test collected between 36-108 hours after your contrast exposure.
Compensation
Not stated in the trial record.
Follow-up
Your kidney function will be monitored with a blood test approximately 34 days after the start of the study drug.

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NCT07016074

Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury

Recruiting
PHASE2Ages 18+InterventionalPrevention
University of Michigan
~100 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:Sodium NitratePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of participants receiving the first dose of blinded study drug within 1-8 hours prior to contrast exposure
Measured over Approximately 34 days
+5 more outcomes measured

Conditions

Kidney Injury, Acute

Explore related trials

Acute Renal Failure

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Hitinder Gurm, MBBS · STUDY_CHAIR · University of Michigan
  • David Hamilton, MD · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Allison Schley
[email protected]
734-232-9051
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Planned coronary angiogram or contrast-enhanced CT scan.
High-risk for contrast-associated acute kidney injury (AKI) with creatine/Glomerular filtration rate (GFR) within 90 days as defined as:
If subject is a woman of child-bearing potential, subject agrees to the use of highly effective contraception starting at screening and during study participation.
Ability to take oral medication and be willing to adhere to the study intervention regimen.
Ability to understand and willingness to agree to an informed consent

Exclusion

Already fulfilling definition of acute kidney injury prior to contrast exposure by kidney disease improving global outcomes (KDIGO) criteria (absolute increase in creatinine from baseline of 0.3mg/dL or more OR relative increase in creatine of 50% or more from baseline).
Primary indication for Percutaneous Coronary Intervention (PCI) including acute ST-segment elevation myocardial infarction
End-stage renal disease actively on dialysis.
Received any intravenous or intraarterial contrast within five days from planned contrast administration.
Cardiac arrest within 14 days of planned contrast administration.
Systolic blood pressure \< 100mmHg or diastolic blood pressure \<60mmHg OR currently receiving inotropes or vasopressors for hemodynamic support.
History of hypersensitivity or known allergy to any of the components of the investigational product or placebo including sodium nitrate, inorganic nitrate, beet root juice, or lactose. This does not include lactose intolerance.
Pregnancy or nursing female
Participation in other investigational trials within the past 30 days prior to enrollment.
Use of tadalafil within 48 hours, sildenafil or vardenafil within 24 hours, and avanafil within 12 hours of initiation of trial medication. If participant is on continuous dosing of tadalafil, sildenafil, vardenafil, or avanafil, they will be excluded from the trial. If participant is on intermittent dosing of tadalafil, sildenafil, vardenafil, or avanafil, patient agrees to withhold use of medication for duration of medication treatment extending 48 hours after the final dose.

What this trial measures

  • Percent of participants receiving the first dose of blinded study drug within 1-8 hours prior to contrast exposureApproximately 34 days

    Success is defined as greater than 80% of patients receiving the first dose of blind study drug within 1-8 hours prior to contrast exposure.

  • Percent of participants completing full course of 4 doses of blinded study drugApproximately 34 days

    Success is defined as greater than 80% of patients completing the full course of 4 doses of blinded study drug

  • Percent of participants with 48-hour basic metabolic panel collected between 36-108 hours of contrast exposureApproximately 34 days

    Success is defined as greater than 80% of patients having appropriately collected 48-hour basic metabolic panel collected 36-108 hours of contrast exposure

  • Percent of participants who had completion of clinical outcome monitoring at 30-day follow-up interviewApproximately 34 days

    Success is defined as greater than 80% of patients completing full clinical outcome monitoring at 30-day follow-up interview.

  • Percent of participants recruited to the trial for undergoing coronary angiogramApproximately 34 days

    Success is defined as four or more patients being recruited into the study prior to coronary angiogram each month of the study averaged over the study period

  • Percent of participants recruited to the trial for undergoing a contrast-enhanced CT scanApproximately 34 days

    Success is defined as four or more patients being recruited into the study prior to contrast-enhanced CT scan each month of the study averaged over the study period.