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

NCT ID: NCT07016074

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2026-07-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Sodium Nitrate

Intervention Type: 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.

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Chili saltpeter

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Hitinder Gurm

Professor of Cardiovascular Medicine, Professor of Internal Medicine, and Chief Medical Officer, Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hitinder Gurm, MBBS

Role: STUDY_CHAIR

University of Michigan

David Hamilton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Allison Schley

Role: CONTACT

schleya@umich.edu

734-232-9051

Facility Contacts

Allison Schley

Role: primary

schleya@med.umich.edu

734-232-9051

Other Identifiers

HUM00263577

Identifier Type: -

Identifier Source: org_study_id