Kidney Injury, AcutePhase 2NCT07016074
Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
A Phase 2 study testing Sodium Nitrate in people with Kidney Injury, Acute, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Injury, Acute
- What is being tested?
- Sodium Nitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2025to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
- OR
- Undergoing contrast-enhanced CT scan with GFR<45 mL/min/1.73m2
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- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Allison Schley, 734-232-9051, schleya@med.umich.edu
David Hamilton, MD
About this study
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.
Read the detailed description
The timing of the follow-up blood test was changed from 48 hours (± 12 hours) to 72 hours (± 36 hours) after contrast exposure. This change allows participants more flexibility to complete their lab work at a convenient outpatient location without requiring a return visit within a narrow time window. The new timing still falls within the period when kidney function changes from contrast exposure would be expected to appear, so the study's ability to detect these changes is preserved and safety monitoring remains consistent.
- Conditions
- Kidney Injury, Acute
- Being tested
- Sodium Nitrate, Placebo
- Keywords
- Sodium Nitrate
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium NitrateDrug
Also called Chili saltpeter
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.
PlaceboDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Sodium Nitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Approximately 34 days
Secondary outcomes (11)
Number of participants who develop of Contrast-Associated Acute Kidney Injury (CA-AKI)
As defined by creatinine measurement at 48 hours after contrast administration meeting Kidney Disease Improving Global Outcomes (KDIGO) criteria
Measured: 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
Measured: 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
Measured: Approximately 34 days
Number of participants with major adverse cardiovascular events (MACE)
MACE is a composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke within 30 days of planned contrast administration
Measured: 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
Measured: Approximately 34 days
Number of participants with non-fatal myocardial infarction within 30 days of planned contrast administration
Measured: Approximately 34 days
Number of participants with non-fatal stroke within 30 days of planned contrast administration
Measured: Approximately 34 days
Number of participants with major adverse kidney events (MAKE)
MAKE is a composite outcome of death, new renal replacement therapy, or persistent renal dysfunction within 30 days of planned contrast administration. Persistent renal dysfunction is defined as creatinine value greater than or equal to 200% of baseline value at 30 days
Measured: Approximately 34 days
Number of participants with persistent renal dysfunction at 30 days of planned contrast administration
Renal dysfunction is defined as creatinine value greater than or equal to 200% of baseline value at 30 days.
Measured: Approximately 34 days
Number of participants with new onset hypotension
Measured: Approximately 34 days
Number of adverse events within 30 days of planned contrast administration
Measured: Approximately 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start30 Jun 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Injury, AcuteStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hitinder Gurm, University of Michigan
- Investigators
- Hitinder Gurm, MBBS, Study chair, University of MichiganDavid Hamilton, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016074
- Sponsor's protocol ID
- HUM00263577
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT07016074
- Acronym / sponsor ID
- HUM00263577
- Conditions
- Kidney Injury, Acute
- Keywords
- Sodium Nitrate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The timing of the follow-up blood test was changed from 48 hours (± 12 hours) to 72 hours (± 36 hours) after contrast exposure. This change allows participants more flexibility to complete their lab work at a convenient outpatient location without requiring a return visit within a narrow time window. The new timing still falls within the period when kidney function changes from contrast exposure would be expected to appear, so the study's ability to detect these changes is preserved and safety monitoring remains consistent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDispensing, 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. |
| Sodium Nitrate | Experimental | Drug: Sodium NitrateDispensing, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- OR
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium NitrateAlso: Chili saltpeterThe 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. | Drug | Sodium Nitrate |
| PlaceboThe 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 | Drug | Placebo |
Primary outcome
Percent of participants receiving the first dose of blinded study drug within 1-8 hours prior to contrast exposure
Time frame: Approximately 34 days
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.
Percent of participants completing full course of 4 doses of blinded study drug
Time frame: Approximately 34 days
Success is defined as greater than 80% of patients completing the full course of 4 doses of blinded study drug
Percent of participants with 48-hour basic metabolic panel collected between 36-108 hours of contrast exposure
Time frame: Approximately 34 days
Success is defined as greater than 80% of patients having appropriately collected 48-hour basic metabolic panel collected 36-108 hours of contrast exposure
Percent of participants who had completion of clinical outcome monitoring at 30-day follow-up interview
Time frame: Approximately 34 days
Success is defined as greater than 80% of patients completing full clinical outcome monitoring at 30-day follow-up interview.
Percent of participants recruited to the trial for undergoing coronary angiogram
Time frame: Approximately 34 days
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
Percent of participants recruited to the trial for undergoing a contrast-enhanced CT scan
Time frame: Approximately 34 days
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.
11 secondary outcomes
Number of participants who develop of Contrast-Associated Acute Kidney Injury (CA-AKI)
Time frame: 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
Time frame: 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
Time frame: Approximately 34 days
Number of participants with major adverse cardiovascular events (MACE)
Time frame: 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
Time frame: Approximately 34 days
Number of participants with non-fatal myocardial infarction within 30 days of planned contrast administration
Time frame: Approximately 34 days
Number of participants with non-fatal stroke within 30 days of planned contrast administration
Time frame: Approximately 34 days
Number of participants with major adverse kidney events (MAKE)
Time frame: Approximately 34 days
Number of participants with persistent renal dysfunction at 30 days of planned contrast administration
Time frame: Approximately 34 days
Number of participants with new onset hypotension
Time frame: Approximately 34 days
Number of adverse events within 30 days of planned contrast administration
Time frame: Approximately 34 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hitinder Gurm, MBBS study chair
University of Michigan
David Hamilton, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Nitrate in people with Kidney Injury, Acute, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Schley (734-232-9051, schleya@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants receiving the first dose of blinded study drug within 1-8 hours prior to contrast exposure (time frame: Approximately 34 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.