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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07016074
Phase
PHASE2
Status
Recruiting
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Conditions

  • Kidney Injury, Acute

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sodium Nitrate — DRUG
    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 — DRUG
    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

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Allison Schley
[email protected]
734-232-9051
David Hamilton, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Michigan· Ann Arbor, MI

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