Recruiting
Phase 2

Sodium Nitrate

Sponsor:

University of Michigan

Code:

NCT07016074

Conditions

Kidney Injury, Acute

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sodium Nitrate

Placebo

Study Details

Brief summary:

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.

Conditions

Kidney Injury, Acute

Study ID

NCT07016074

Start date

Jun 30, 2025

Status verified date

Jul, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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:

1. Undergoing coronary angiogram with GFR <45 mL/min/1.73m2 OR
2. 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
3. Undergoing contrast-enhanced CT scan with GFR<45 mL/min/1.73m2
  • 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 Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

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.

experimental: Sodium Nitrate

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.

Interventions

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.

Placebo

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

Primary outcome measure

  • Percent of participants receiving the first dose of blinded 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 [ Time Frame: Approximately 34 days ]
  • Percent of participants with 48-hour basic metabolic panel collected between 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 [ Time Frame: Approximately 34 days ]
  • Percent of participants recruited to the trial for undergoing coronary angiogram [ Time Frame: Approximately 34 days ]
  • Percent of participants recruited to the trial for undergoing a contrast-enhanced CT scan [ Time Frame: Approximately 34 days ]

Central Contacts and Locations

Central contacts

Allison Schley

734-232-9051schleya@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Allison Schley

734-232-9051schleya@med.umich.edu

Principal Investigator:

David Hamilton, MD

More Information

Sponsor

University of Michigan

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Sodium Nitrate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-22. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.