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Prevention study for Acute Kidney Injury
Official title Melatonin for Prevention of Kidney Injury
ClinicalTrials.gov ID: NCT05084196
What this study is testing
What is Melatonin?
Melatonin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute kidney injury.
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 study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged 18 to 75 years
- Currently prescribed vancomycin with the presumption that therapy will be continued for at least 3 days based on a review of subject status. Because...
You likely can't join if
- Estimated creatinine clearance \< 30 mL/min
- Liver impairment (liver enzymes \> 3 times upper limit)
- Any history of allergy or contraindication to melatonin
- Pregnancy or breastfeeding
- Autoimmune disease
- Requiring vasopressors
See the full eligibility criteria
- Aged 18 to 75 years
- Currently prescribed vancomycin with the presumption that therapy will be continued for at least 3 days based on a review of subject status. Because of the critical nature of starting empiric broad-spectrum antibiotics...
- Estimated creatinine clearance \< 30 mL/min
- Liver impairment (liver enzymes \> 3 times upper limit)
- Any history of allergy or contraindication to melatonin
- Pregnancy or breastfeeding
- Autoimmune disease
- Requiring vasopressors
- Requiring mechanical ventilation
- History of acute kidney injury in the past 30 days
- Inability to take oral medications
- Clinical evidence of significant unstable or uncontrolled illness which, in the opinion of the research team, could confound the results of the study or put the patient at undue risk.
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
- Somerville, New Jersey, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States; Somerville, New Jersey, 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.