NCT05084196

Melatonin for Prevention of Kidney Injury

Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Consenting subjects meeting inclusion and exclusion will be randomized to receive melatonin 5 mg daily or a matching placebo. Study subjects will be followed for the duration of hospitalization or discontinuation of broad spectrum antibiotics (vancomycin plus piperacillin/tazobactam). The primary outcome and secondary outcomes will be evaluated by the study team.

Conditions

• Acute Kidney Injury
• Adverse Drug Event

Interventions

Type	Name	Description
DRUG	Melatonin	Melatonin 5 mg capsule by mouth at bedtime
OTHER	Placebo Capsule	Placebo capsule by mouth at bedtime

Timeline

• Start date: 2023-06-05
• Primary completion: 2027-06-01
• Completion: 2027-12-31
• First posted: 2021-10-19
• Last updated: 2025-12-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study