Melatonin for Prevention of Kidney Injury

NCT05084196 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: Pro2021001502
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Adverse Drug Event; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury

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

  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

Other Outcomes (9)

• Melatonin plasma trough concentration

  Days 3, 5, and 7

• Piperacillin/tazobactam plasma trough concentration

  Days 3, 5, and 7

• Vancomycin plasma Area Under the Curve (AUC)

  Days 3, 5, and 7

Study Arms (2)

Melatonin Arm

EXPERIMENTAL

Melatonin 5 mg capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.

Drug: Melatonin

Placebo Arm

PLACEBO COMPARATOR

Placebo capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.

Other: Placebo Capsule

Interventions

Placebo Capsule OTHER

Placebo capsule by mouth at bedtime

Placebo Arm

Melatonin DRUG

Melatonin 5 mg capsule by mouth at bedtime

Melatonin Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Drug-Related Side Effects and Adverse Reactions

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Luigi Brunetti, PhD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luigi Brunetti, PhD

CONTACT

908-595-2645; luigi.brunetti@rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 19, 2021
• Study Start: June 5, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)