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NCT Number: NCT05084196

Melatonin for Prevention of Kidney Injury

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

Recruiting

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Key information

Conditions

Acute Kidney Injury Adverse Drug Event Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Melatonin

Drug

Melatonin 5 mg capsule by mouth at bedtime

Placebo capsule

Other

Placebo capsule by mouth at bedtime

Primary outcomes

  1. 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

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

Other outcomes

  1. Melatonin plasma trough concentration

    Time frame: Days 3, 5, and 7

    Evaluate the steady state plasma trough concentration of melatonin

  2. Piperacillin/tazobactam plasma trough concentration

    Time frame: Days 3, 5, and 7

    Evaluate the steady state plasma trough concentration of piperacillin/tazobactam

  3. Vancomycin plasma Area Under the Curve (AUC)

    Time frame: Days 3, 5, and 7

    Evaluate the steady state plasma AUC of vancomycin

  4. Association between Kidney Injury Molecule-1 (KIM-1) and serum creatinine

    Time frame: Days 3, 5, and 7

    Measure KIM-1 in plasma and urine and evaluate discordance between serum creatinine.

  5. Mitochondrial stress assessment via extracellular flux analysis to measure oxygen consumption rate of cells

    Time frame: Days 1 and 3

    Evaluate mitochondrial stress in peripheral blood mononuclear cells from a subset of subjects in each group. In addition, mitochondrial stress will be evaluated on day 3 in a subset in the melatonin group.

  6. Urine mitochondrial DNA copy number

    Time frame: Days 1, 3, 5, and 7

    Measure mitochondrial DNA (mtDNA) in urine samples using polymerase chain reaction (PCR).

  7. Fold-change in NRF-2 gene expression in peripheral blood mononuclear cells

    Time frame: Days 1 and 5

    Measure gene expression level at baseline and then on day 5 (or last day of study if earlier) using polymerase chain reaction (PCR) and compare the fold-change from baseline between groups.

  8. Number of subjects with NRF2 DNA single nucleotide polymorphisms

    Time frame: Day 1

    Determination of the number of individuals with NRF2 DNA single nucleotide polymorphisms in the study population and compare the incidence of primary outcome in those with and without polymorphisms.

  9. Number of subjects with KEAP1 DNA single nucleotide polymorphisms

    Time frame: Day 1

    Determination of the number of individuals with KEAP1 DNA single nucleotide polymorphisms in the study population and compare the incidence of primary outcome in those with and without polymorphisms.

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Brunetti, PhD

CONTACT

[email protected]

908-595-2645

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 19, 2021
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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