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NCT05084196 · ClinicalTrials.gov registry record · Phase 3
Melatonin for Prevention of Kidney Injury
A Phase 3 study of Acute Kidney Injury and Adverse Drug Event, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 2
- Study locations
NCT05084196: Recruiting Phase 3 study of Acute Kidney Injury and Adverse Drug Event, sponsored by Rutgers, The State University of New Jersey.
NCT05084196 is a Phase 3 study of Acute Kidney Injury and Adverse Drug Event that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 300 participants, below the 2,327-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05084196, a Phase 3 study of Acute Kidney Injury and Adverse Drug Event, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
Primary Outcome
Acute kidney injury will be defined as an increase in sCr from baseline of \>/= 0.3 mg/dL or a \>/= 50% increase from baseline.
Conditions Studied
Interventions
- DRUG Melatonin
- OTHER Placebo Capsule
Study Locations (2)
New Jersey
- Robert Wood Johnson University Hospital - New Brunswick
- Robert Wood Johnson University Hospital Somerset - Somerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-06-05 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
What NCT05084196 shows while recruiting
NCT05084196 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 2,327-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 2 interventions - of which Melatonin is the first listed.
NCT05084196 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT05084196 about?
NCT05084196 is a clinical study titled "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.
What is the current status of trial NCT05084196?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2023-06-05. Estimated completion is 2027-12-31.
What conditions does trial NCT05084196 study?
This clinical trial studies the following conditions: Acute Kidney Injury, Adverse Drug Event.
What interventions are being tested in trial NCT05084196?
The interventions under investigation include: Melatonin (DRUG), Placebo Capsule (OTHER).
Who is sponsoring clinical trial NCT05084196?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05084196 being conducted?
This trial has 2 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Kidney Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05084196's enrollment target sits among peer trials
300 25th of 74 higher than 48 of 74 other Acute Kidney Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Kidney Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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