A Phase 2 interventional study of Sodium Nitrate and Placebo in Kidney Injury, Acute, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by University of Michigan · Phase 2, Interventional, and Prevention
This pilot study is designed to test the logistics and recruitment of a trial testing the benefit of sodium nitrate in the prevention of contrast-associated kidney injury in a group of patients at high-risk.
The timing of the follow-up blood test was changed from 48 hours (± 12 hours) to 72 hours (± 36 hours) after contrast exposure. This change allows participants more flexibility to complete their lab work at a convenient outpatient location without requiring a return visit within a narrow time window. The new timing still falls within the period when kidney function changes from contrast exposure would be expected to appear, so the study's ability to detect these changes is preserved and safety monitoring remains consistent.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
High-risk for contrast-associated acute kidney injury (AKI) with creatine/Glomerular filtration rate (GFR) within 90 days as defined as:
Undergoing coronary angiogram with GFR \<60 mL/min/1.73m2 and concurrent risk of AKI as defined by Hamilton et al. BMC2 risk prediction model ≥ 7%.
OR
Exclusion Criteria:
Dispensing, and Labeling: The University of Michigan Research Pharmacy will compound sodium nitrate and placebo capsules. Placebo capsules will be compounded by filling a matching capsule with lactose.
Drug: Placebo
Dispensing, and Labeling: The University of Michigan Research Pharmacy will compound sodium nitrate and placebo capsules. Sodium nitrate powder will be measure and used for the active capsules with adding lactose as a filler.
Drug: Sodium Nitrate
The study drug is sodium nitrate capsule at a dose of 12mmol of nitrate. This medication will be given orally 1-8 hours before the planned contrast administration and then once per day for a total of four doses.
Also known as: Chili saltpeter
The placebo control medication will be a capsule filled with lactose that will be taken in the same manner and schedule as the sodium nitrate capsule
Percent of participants receiving the first dose of blinded study drug within 1-8 hours prior to contrast exposure
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.
Time frame: Approximately 34 days
Percent of participants completing full course of 4 doses of blinded study drug
Success is defined as greater than 80% of patients completing the full course of 4 doses of blinded study drug
Time frame: Approximately 34 days
Percent of participants with 48-hour basic metabolic panel collected between 36-108 hours of contrast exposure
Success is defined as greater than 80% of patients having appropriately collected 48-hour basic metabolic panel collected 36-108 hours of contrast exposure
Time frame: Approximately 34 days
Percent of participants who had completion of clinical outcome monitoring at 30-day follow-up interview
Success is defined as greater than 80% of patients completing full clinical outcome monitoring at 30-day follow-up interview.
Time frame: Approximately 34 days
Percent of participants recruited to the trial for undergoing coronary angiogram
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
Time frame: Approximately 34 days
Percent of participants recruited to the trial for undergoing a contrast-enhanced CT scan
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.
Time frame: Approximately 34 days
Number of participants who develop of Contrast-Associated Acute Kidney Injury (CA-AKI)
As defined by creatinine measurement at 48 hours after contrast administration meeting Kidney Disease Improving Global Outcomes (KDIGO) criteria
Time frame: Approximately 34 days
Number of participants who had initiation of renal replacement therapy within 30 days of planned contrast administration for patients that did not have active need for dialysis prior to study enrollment
Time frame: Approximately 34 days
Number of participants with all-cause mortality within 30 days of planned contrast administration as defined by cessation of life due to any cause
Time frame: Approximately 34 days
Number of participants with major adverse cardiovascular events (MACE)
MACE is a composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke within 30 days of planned contrast administration
Time frame: Approximately 34 days
Number of participants with cardiovascular death within 30 days of planned contrast administration as defined by cessation of life deemed secondary to cardiovascular cause
Time frame: Approximately 34 days
Number of participants with non-fatal myocardial infarction within 30 days of planned contrast administration
Time frame: Approximately 34 days
Number of participants with non-fatal stroke within 30 days of planned contrast administration
Time frame: Approximately 34 days
Number of participants with major adverse kidney events (MAKE)
MAKE is a composite outcome of death, new renal replacement therapy, or persistent renal dysfunction within 30 days of planned contrast administration. Persistent renal dysfunction is defined as creatinine value greater than or equal to 200% of baseline value at 30 days
Time frame: Approximately 34 days
Number of participants with persistent renal dysfunction at 30 days of planned contrast administration
Renal dysfunction is defined as creatinine value greater than or equal to 200% of baseline value at 30 days.
Time frame: Approximately 34 days
Number of participants with new onset hypotension
Time frame: Approximately 34 days
Number of adverse events within 30 days of planned contrast administration
Time frame: Approximately 34 days
Plan to share: No
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