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

NCT07016074 | Recruiting Phase 2 FDA Drug

• 1 other identifier: HUM00263577
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Sodium Nitrate

Outcome Measures

Primary Outcomes (6)

• Percent of participants receiving the first dose of blinded study drug within 1-8 hours prior to contrast exposure

  Success is defined as greater than 80% of patients receiving the first dose of blind study drug within 1-8 hours prior to contrast exposure.

  Approximately 34 days

• Percent of participants completing full course of 4 doses of blinded study drug

  Success is defined as greater than 80% of patients completing the full course of 4 doses of blinded study drug

  Approximately 34 days

• Percent of participants with 48-hour basic metabolic panel collected between 36-108 hours of contrast exposure

  Success is defined as greater than 80% of patients having appropriately collected 48-hour basic metabolic panel collected 36-108 hours of contrast exposure

  Approximately 34 days

• Percent of participants who had completion of clinical outcome monitoring at 30-day follow-up interview

  Success is defined as greater than 80% of patients completing full clinical outcome monitoring at 30-day follow-up interview.

  Approximately 34 days

• Percent of participants recruited to the trial for undergoing coronary angiogram

  Success is defined as four or more patients being recruited into the study prior to coronary angiogram each month of the study averaged over the study period

  Approximately 34 days

• Percent of participants recruited to the trial for undergoing a contrast-enhanced CT scan

  Success is defined as four or more patients being recruited into the study prior to contrast-enhanced CT scan each month of the study averaged over the study period.

  Approximately 34 days

Secondary Outcomes (11)

• Number of participants who develop of Contrast-Associated Acute Kidney Injury (CA-AKI)

  Approximately 34 days

• Number of participants who had initiation of renal replacement therapy within 30 days of planned contrast administration for patients that did not have active need for dialysis prior to study enrollment

  Approximately 34 days

• Number of participants with all-cause mortality within 30 days of planned contrast administration as defined by cessation of life due to any cause

  Approximately 34 days

• Number of participants with major adverse cardiovascular events (MACE)

  Approximately 34 days

• Number of participants with cardiovascular death within 30 days of planned contrast administration as defined by cessation of life deemed secondary to cardiovascular cause

  Approximately 34 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Sodium Nitrate

EXPERIMENTAL

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.

Drug: Sodium Nitrate

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.

Also known as: Chili saltpeter

Sodium Nitrate

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Undergoing coronary angiogram with GFR \<45 mL/min/1.73m2 OR
• 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%.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

sodium nitrate

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hitinder Gurm, MBBS

  University of Michigan

  STUDY CHAIR

• David Hamilton, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Schley

CONTACT

734-232-9051; schleya@umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Medicine, Professor of Internal Medicine, and Chief Medical Officer, Medical School

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)