Sodium nitrate to prevent contrast-associated acute kidney injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 pilot tests the logistics and recruitment for using oral sodium nitrate as a preventive measure against contrast-associated acute kidney injury in high-risk patients undergoing coronary angiography or contrast-enhanced CT. Participants are assigned to receive sodium nitrate or a matching placebo around the time of their contrast exposure, with baseline and follow-up blood tests to monitor kidney function. Follow-up creatinine testing is scheduled at about 72 hours (±36 hours) after contrast to allow flexible outpatient lab completion while still capturing expected kidney function changes. The focus is both on feasibility and on collecting preliminary signals of safety and potential efficacy to inform larger trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: David Hamilton, MD — University of Michigan
• Study coordinator: Allison Schley
• Email: schleya@umich.edu
• Phone: 734-232-9051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.