NCT07016074

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Kidney Injury, Acute

Interventions

Type	Name	Description
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.
DRUG	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

Timeline

• Start date: 2025-06-30
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-06-11
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study