NCT07016074 Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
| NCT ID | NCT07016074 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Michigan |
| Condition | Kidney Injury, Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-06-30 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Hitinder Gurm, MBBS
STUDY CHAIR
University of Michigan
Frequently Asked Questions
Who can join the NCT07016074 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Kidney Injury, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07016074 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07016074 currently recruiting?
Yes, NCT07016074 is actively recruiting participants. Contact the research team at schleya@umich.edu for enrollment information.
Where is the NCT07016074 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07016074 clinical trial?
NCT07016074 is sponsored by University of Michigan. The principal investigator is Hitinder Gurm, MBBS at University of Michigan. The trial plans to enroll 100 participants.
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