Sodium Nitrate for Acute Kidney Injury

Overseen By Allison Schley

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan

Must not be taking: Tadalafil, Sildenafil, Vardenafil, Avanafil

Disqualifiers: Acute kidney injury, Dialysis, Cardiac arrest, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 34

Duration: Approximately 34 days

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether sodium nitrate (an inorganic nitrate, NaNO3) can prevent kidney damage after certain medical imaging tests using contrast dye. It specifically targets individuals at high risk for kidney problems following a coronary angiogram (heart artery imaging) or a contrast-enhanced CT scan. Participants should plan to undergo one of these tests and have known kidney issues or risks. The trial includes two groups: one receiving sodium nitrate and the other a placebo (a harmless pill with no active ingredient). The study aims to determine if sodium nitrate offers a protective benefit for the kidneys. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications like tadalafil, sildenafil, vardenafil, or avanafil before and during the trial. If you take these medications continuously, you cannot participate. If you take them occasionally, you must stop for the trial duration and 48 hours after the last dose.

Is there any evidence suggesting that sodium nitrate is likely to be safe for humans?

Research has suggested that sodium nitrate might be safe for people. In one study, patients at risk of kidney damage took a short five-day course of inorganic nitrate and experienced benefits without serious side effects. Another study demonstrated that inorganic nitrates improved kidney health in patients undergoing certain heart procedures. While these results are encouraging, ongoing research aims to fully understand the safety and effectiveness of sodium nitrate in preventing kidney damage. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for kidney injury?

Sodium nitrate is unique because it introduces an inorganic nitrate to tackle acute kidney injury, which is a fresh approach compared to the usual reliance on hydration and supportive care. Unlike standard treatments that aim to manage symptoms and support kidney function indirectly, sodium nitrate may directly enhance renal blood flow and improve oxygen delivery to the kidneys. Researchers are excited about this potential because it offers a novel mechanism that could directly mitigate the impact of kidney injury, possibly leading to faster and more effective recovery.

What evidence suggests that sodium nitrate might be an effective treatment for acute kidney injury?

Research has shown that sodium nitrate, which participants in this trial may receive, might protect the kidneys from damage caused by contrast agents used in imaging tests. One study demonstrated that using inorganic nitrates significantly reduced the risk of kidney injury from 30.5% to 9.1%. Another study found that it also lowered the chance of heart problems during procedures, from 12.5% to 2.7%. Additionally, sodium nitrate may help safeguard the kidneys before they face stress or damage, potentially preventing sudden kidney injury. These findings suggest that sodium nitrate could be a useful treatment for preventing kidney damage in people at risk. ^{1 2 3 4 6}

Who Is on the Research Team?

Hitinder Gurm, MBBS

Principal Investigator

University of Michigan

David Hamilton, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for high-risk patients who may develop kidney injury after being exposed to contrast agents, which are special dyes used in some medical imaging tests. Specific eligibility details aren't provided, but typically participants must meet certain health criteria and not have conditions that could interfere with the study or their safety.

Inclusion Criteria

I can take pills and will follow the study's treatment plan.

I can understand and agree to the informed consent.

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

Exclusion Criteria

I haven't had any contrast agents given through IV or artery in the last 5 days.

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

Already fulfilling definition of acute kidney injury prior to contrast exposure by kidney disease improving global outcomes (KDIGO) criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sodium nitrate or placebo capsules prior to contrast exposure

Approximately 34 days

4 doses of study drug

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 30-day follow-up interview

4 weeks

30-day follow-up interview

What Are the Treatments Tested in This Trial?

Interventions

• Inorganic Nitrate (NaNO3)

Trial Overview

The study is testing whether sodium nitrate can prevent kidney damage caused by contrast agents during imaging procedures. Participants will be randomly assigned to receive either sodium nitrate or a placebo (a substance with no therapeutic effect) to compare outcomes.

How Is the Trial Designed?

Group I: Sodium Nitrate Experimental Treatment 1 Intervention

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 II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07016074

Study Details | NCT07016074 | Inorganic Nitrate (NaNO3) ...

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 ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11089333/

Inorganic nitrate benefits contrast-induced nephropathy after ...

Secondary outcomes were improved with inorganic nitrate, with lower rates of procedural myocardial infarction (2.7% vs. 12.5%, P = . 003), ...

3.

withpower.com

withpower.com/trial/phase-2-acute-kidney-injury-5-2025-eb9dd

Sodium Nitrate for Acute Kidney Injury

Trial Overview The study is testing whether sodium nitrate can prevent kidney damage caused by contrast agents during imaging procedures. Participants will be ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213231720310417

Renovascular effects of inorganic nitrate following ...

Conclusions. Acute treatment with inorganic nitrate prior to renal ischemia may serve as a novel therapeutic approach to prevent AKI and CKD and associated risk ...

5.

acc.org

acc.org/Latest-in-Cardiology/Journal-Scans/2024/04/24/13/43/inorganic-nitrate-benefits

Inorganic Nitrates to Protect Against Contrast-Induced ...

KNO3 therapy was associated with a significant reduction in CIN (9.1% vs. 30.5%) and improved kidney outcomes at 3 months.

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2213231717304172

Dietary nitrate attenuates renal ischemia-reperfusion ...

Our study demonstrates protective effect of dietary nitrate in renal IR injury that may be mediated via modulation of oxidative stress and inflammatory ...