NCT05084196 Melatonin for Prevention of Kidney Injury
| NCT ID | NCT05084196 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-06-05 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2023-06-05 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.
Eligibility Criteria
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.
Contact & Investigator
Luigi Brunetti, PhD
PRINCIPAL INVESTIGATOR
Rutgers, The State University of New Jersey
Frequently Asked Questions
Who can join the NCT05084196 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05084196 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT05084196 currently recruiting?
Yes, NCT05084196 is actively recruiting participants. Contact the research team at luigi.brunetti@rutgers.edu for enrollment information.
Where is the NCT05084196 trial being conducted?
This trial is being conducted at New Brunswick, United States, Somerville, United States.
Who is sponsoring the NCT05084196 clinical trial?
NCT05084196 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Luigi Brunetti, PhD at Rutgers, The State University of New Jersey. The trial plans to enroll 300 participants.
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