Melatonin for Prevention of Kidney Injury

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Acute Kidney Injury, Adverse Drug Event

In brief

This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.

Key facts

Study ID

NCT05084196

Run by

Rutgers, The State University of New Jersey

People needed

300

Starts

2023-06-05

Expected to finish

2027-12-31

Last updated by the study team

2025-12-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 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.

You may not qualify 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
• 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.

Where it is running

• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (enrolling)
• Robert Wood Johnson University Hospital Somerset — Somerville, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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