RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-30

Study Completion:2026-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07016074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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%. 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	* 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.

Inclusion Criteria

Exclusion 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%.
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

* 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.

Contacts and Locations

Study Contact

Allison Schley

CONTACT

734-232-9051

schleya@umich.edu

Principal Investigator

Hitinder Gurm, MBBS

STUDY_CHAIR

University of Michigan

David Hamilton, MD

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: University of Michigan

Hitinder Gurm, MBBS, STUDY_CHAIR, University of Michigan
David Hamilton, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30

Study Completion Date2026-07

Study Record Updates

Study Start Date2025-06-30

Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

Sodium Nitrate

Additional Relevant MeSH Terms

Kidney Injury, Acute