Melatonin for Prevention of Kidney Injury

Part of paid clinical trials in New Brunswick, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05084196
Phase
PHASE3
Status
Recruiting
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Conditions

  • Acute Kidney Injury
  • Adverse Drug Event

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Melatonin — DRUG
    Melatonin 5 mg capsule by mouth at bedtime
  • Placebo Capsule — OTHER
    Placebo capsule by mouth at bedtime

Study Details

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

Key Dates

Start date
Jun 5, 2023
Status verified
Nov 2025
Primary completion
Jun 1, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Melatonin Arm
    Melatonin 5 mg capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.
  • Placebo Comparator: Placebo Arm
    Placebo capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.

Primary Outcome Measure

Acute kidney injury [ Time Frame: 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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Robert Wood Johnson University HospitalNew BrunswickNew Jersey08901
Pinki Bhatt, MD
[email protected]
732-235-2898
Robert Wood Johnson University Hospital SomersetSomervilleNew Jersey08876
Luigi Brunetti, PhD
[email protected]
2016385868
Luigi Brunetti, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Brunswick, NJ

By research site
Robert Wood Johnson University Hospital· New Brunswick, NJRobert Wood Johnson University Hospital Somerset· Somerville, NJ

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