BridgeMD
Prevention study for Kidney Injury, Acute
Official title Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
ClinicalTrials.gov ID: NCT07016074
What this study is testing
What is Sodium Nitrate?
Sodium Nitrate is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for kidney injury, acute.
Also referred to as Chili saltpeter.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Already fulfilling definition of acute kidney injury prior to contrast exposure by kidney disease improving global outcomes (KDIGO) criteria...
- 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.
See the full eligibility 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:
- 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
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.