Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT05084196

Melatonin for Prevention of Kidney Injury

Led by Rutgers, The State University of New Jersey · Updated on 2025-12-17

300

Participants Needed

2

Research Sites

238 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Melatonin for Prevention of Kidney Injury

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years
  • Currently prescribed vancomycin with the plan to continue therapy for at least 3 days
  • One dose of vancomycin and piperacillin/tazobactam allowed before consent and enrollment due to urgent treatment needs
Not Eligible

You will not qualify if you...

  • Estimated creatinine clearance less than 30 mL/min
  • Liver impairment with liver enzymes greater than three times the upper limit
  • 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
  • Significant unstable or uncontrolled illness that could affect study results or safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

2

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States, 08876

Actively Recruiting

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Research Team

L

Luigi Brunetti, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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