Actively Recruiting
Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
Led by University of Michigan · Updated on 2026-02-24
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of sodium nitrate to prevent contrast-associated acute kidney injury in patients at high risk who are undergoing coronary angiogram or contrast-enhanced CT scans. This Phase 2 pilot study aims to test the logistics and recruitment processes while assessing the potential benefit of sodium nitrate compared to placebo in this population. The study is sponsored by the University of Michigan and focuses on patients with reduced kidney function who face increased risk from contrast exposure. Participants will be randomly assigned to receive either sodium nitrate capsules or placebo capsules. The active sodium nitrate is given orally at a dose of 12 mmol nitrate, starting 1 to 8 hours before contrast administration, then once daily for a total of four doses. Placebo capsules contain lactose and follow the same dosing schedule. Capsules are prepared and labeled by the University of Michigan Research Pharmacy. Follow-up blood tests to monitor kidney function have been adjusted to 72 hours (±36 hours) after contrast exposure to provide flexibility for outpatient lab work. During the study, participants will be monitored for adherence to the dosing schedule and will undergo kidney function tests, including a basic metabolic panel, within 36 to 108 hours after contrast exposure. Additional follow-up includes clinical outcome monitoring at 30 days to assess kidney injury, cardiovascular events, and adverse effects. The primary outcomes focus on dosing compliance and timely laboratory assessments, while secondary outcomes include the occurrence of acute kidney injury, need for renal replacement therapy, mortality, and cardiovascular events. The total participation time is approximately 34 days.
CONDITIONS
Brief Title
Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned coronary angiogram or contrast-enhanced CT scan.
- High-risk for contrast-associated acute kidney injury with creatinine or glomerular filtration rate (GFR) measured within 90 days.
- Undergoing coronary angiogram with GFR less than 45 mL/min/1.73m2 OR
- Undergoing coronary angiogram with GFR less than 60 mL/min/1.73m2 and risk of AKI as defined by Hamilton et al. BMC2 risk prediction model at 7% or higher.
- Undergoing contrast-enhanced CT scan with GFR less than 45 mL/min/1.73m2.
- Women of child-bearing potential must agree to use highly effective contraception starting at screening and during study participation.
- Able to take oral medication and willing to follow the study treatment schedule.
- Able to understand and willing to agree to informed consent.
You will not qualify if you...
- Already have acute kidney injury before contrast exposure by KDIGO criteria.
- Planned primary percutaneous coronary intervention including acute ST-segment elevation myocardial infarction.
- End-stage renal disease on dialysis.
- Received intravenous or intraarterial contrast within five days before planned contrast administration.
- Cardiac arrest within 14 days before planned contrast administration.
- Systolic blood pressure less than 100 mmHg or diastolic less than 60 mmHg, or currently receiving inotropes or vasopressors.
- History of allergy to components of the study drug or placebo including sodium nitrate, inorganic nitrate, beet root juice, or lactose (excluding lactose intolerance).
- Pregnant or nursing female.
- Participation in another investigational trial within 30 days prior to enrollment.
- Use of tadalafil within 48 hours, sildenafil or vardenafil within 24 hours, or avanafil within 12 hours before starting trial medication, or continuous dosing of these drugs without withholding during the study period.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 days
Participants take the blinded study drug capsule orally 1 to 8 hours before the planned contrast administration and then once daily for a total of four doses.
1 to 2 visits around contrast exposure
Duration - Up to 30 days
Participants complete blood tests and clinical outcome monitoring to assess kidney function and safety after contrast exposure.
1 blood test visit between 36 to 108 hours after contrast exposure and 1 follow-up interview at 30 days
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
A
Allison Schley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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