Melatonin for Prevention of Kidney Injury

Phase 3

Recruiting

• Conditions: Acute Kidney Injury; Adverse Drug Event
• Interventions: Other: Placebo Capsule; Drug: Melatonin

• Registration Number: NCT05084196
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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.

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Study Start: 2023-06-05
• Status Verified: 2023-12
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo Capsule	Placebo capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.
Melatonin Arm	Melatonin	Melatonin 5 mg capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.

Primary Outcome Measures

Name	Time	Method
Acute kidney injury	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	Acute kidney injury will be defined as an increase in sCr from baseline of \>/= 0.3 mg/dL or a \>/= 50% increase from baseline.

Trial Locations

Locations (2)

Robert Wood Johnson University Hospital; 🇺🇸 New Brunswick, New Jersey, United States

Robert Wood Johnson University Hospital Somerset; 🇺🇸 Somerville, New Jersey, United States