A Phase 3 interventional study of Melatonin and Placebo Capsule in Acute Kidney Injury and Adverse Drug Event, sponsored by Rutgers, The State University of New Jersey. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Rutgers, The State University of New Jersey · Phase 3, Interventional, and Prevention
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
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.
1,594 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
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 capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.
Other: Placebo Capsule
Melatonin 5 mg capsule by mouth at bedtime
Placebo capsule by mouth at bedtime
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.
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
Melatonin plasma trough concentration
Evaluate the steady state plasma trough concentration of melatonin
Time frame: Days 3, 5, and 7
Piperacillin/tazobactam plasma trough concentration
Evaluate the steady state plasma trough concentration of piperacillin/tazobactam
Time frame: Days 3, 5, and 7
Vancomycin plasma Area Under the Curve (AUC)
Evaluate the steady state plasma AUC of vancomycin
Time frame: Days 3, 5, and 7
Association between Kidney Injury Molecule-1 (KIM-1) and serum creatinine
Measure KIM-1 in plasma and urine and evaluate discordance between serum creatinine.
Time frame: Days 3, 5, and 7
Mitochondrial stress assessment via extracellular flux analysis to measure oxygen consumption rate of cells
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.
Time frame: Days 1 and 3
Urine mitochondrial DNA copy number
Measure mitochondrial DNA (mtDNA) in urine samples using polymerase chain reaction (PCR).
Time frame: Days 1, 3, 5, and 7
Fold-change in NRF-2 gene expression in peripheral blood mononuclear cells
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.
Time frame: Days 1 and 5
Number of subjects with NRF2 DNA single nucleotide polymorphisms
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.
Time frame: Day 1
Number of subjects with KEAP1 DNA single nucleotide polymorphisms
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.
Time frame: Day 1
Plan to share: No
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Rutgers, The State University of New Jersey