Sodium Nitrate for Acute Kidney Injury
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.12345
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.12346
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sodium nitrate or placebo capsules prior to contrast exposure
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a 30-day follow-up interview
What Are the Treatments Tested in This Trial?
Interventions
- Inorganic Nitrate (NaNO3)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor