Melatonin for Prevention of Kidney Injury

This study is looking at whether melatonin can help prevent acute kidney injury (AKI) in hospitalized patients who are taking certain antibiotics. AKI is a sudden decrease in kidney function. You might be able to join if you are between 18 and 75 years old and are prescribed vancomycin, an antibiotic, for at least three days. The study aims to see if melatonin 5 mg taken nightly can reduce the chance of developing AKI compared to a placebo (an inactive pill). The study plans to enroll 300 participants, but the current recruitment status is unclear.

Study design: This is an interventional study where participants will be randomly assigned to receive either melatonin or a placebo. It plans to enroll 300 participants.
What's involved: You would take a capsule by mouth at bedtime. You would be followed for the duration of your hospitalization or until broad-spectrum antibiotics are stopped.
Compensation: Not stated in the trial record.
Follow-up: You would be followed for acute kidney injury from the date of randomization until the first documented AKI or antibiotic discontinuation, up to 28 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Melatonin for Prevention of Kidney Injury

Recruiting

PHASE3Ages 18–75InterventionalPrevention

Rutgers, The State University of New Jersey

~300 participants

Updated 2025-12-17 on ClinicalTrials.gov

What's tested:MelatoninPlacebo Capsule

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Acute kidney injury

Measured over From date of randomization until the date of first documented acute kidney injury or date of antibiotic discontinuation, whichever came first, assessed up to 28 days

Conditions

Acute Kidney Injury

Adverse Drug Event

Where it's being run

2 sites across 1 states

New Jersey2

Study leadership

Luigi Brunetti, PhD · PRINCIPAL_INVESTIGATOR · Rutgers, The State University of New Jersey

Who to contact

Luigi Brunetti, PhD

[email protected]

908-595-2645

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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, we will allow one dose of the antibiotic combination before consent and enrollment. This strategy is necessary for the ethical conduct of the study.

Exclusion

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.

What this trial measures

Acute kidney injuryFrom date of randomization until the date of first documented acute kidney injury or date of antibiotic discontinuation, whichever came first, assessed up to 28 days
Acute kidney injury will be defined as an increase in sCr from baseline of \>/= 0.3 mg/dL or a \>/= 50% increase from baseline.

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