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Melatonin for Acute Kidney Injury

Phase 3

Recruiting

Led By Luigi Brunetti, PhD

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 to 75 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 3, 5, and 7

Awards & highlights

Study Summary

This trial will test if melatonin can reduce kidney injury in hospital patients taking antibiotics.

Who is the study for?

This trial is for hospitalized patients aged 18-65 who are taking antibiotics vancomycin and piperacillin/tazobactam, expected to continue for at least 3 days. It's not for those with severe kidney issues, pregnant or breastfeeding women, people unable to take oral meds, unstable illnesses, recent acute kidney injury, significant liver problems, melatonin allergies, autoimmune diseases or those on strong heart medications or ventilators.Check my eligibility

What is being tested?

The study tests if melatonin can prevent kidney damage in patients receiving certain antibiotics. Participants will either receive a placebo capsule or melatonin alongside their antibiotic treatment to compare the safety and effectiveness of melatonin against no active intervention.See study design

What are the potential side effects?

Melatonin may cause drowsiness, dizziness, headaches and nausea. Since it's being tested with specific antibiotics known to potentially affect kidneys differently than usual medication side effects might occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 3, 5, and 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 3, 5, and 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 3, 5, and 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute kidney injury

Other outcome measures

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

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

Melatonin plasma trough concentration

+6 more

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373

42%

Fatigue

39%

Early Morning Wakening

36%

Daytime drowsiness

11%

Weakness

11%

Dizziness

11%

Nausea

11%

Blurred vision

100%

80%

60%

40%

20%

Study treatment Arm

Melatonin

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Melatonin ArmExperimental Treatment1 Intervention

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

Group II: Placebo ArmPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melatonin

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

63,932 Total Patients Enrolled

1 Trials studying Acute Kidney Injury

13 Patients Enrolled for Acute Kidney Injury

Luigi Brunetti, PhDPrincipal InvestigatorRutgers, The State University of New Jersey

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Melatonin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05084196 — Phase 3

Acute Kidney Injury Research Study Groups: Placebo Arm, Melatonin Arm

Acute Kidney Injury Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT05084196 — Phase 3

Melatonin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05084196 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to adults over the age of 25?

"The enrollment criteria for this medical trial set a minimum age of majority and an upper limit of 65 years old."

Answered by AI

Are there any openings in this clinical investigation at the present moment?

"According to the latest records on clinicaltrials.gov, this trial is presently recruiting participants that meet the enrolled criteria and can be traced back to June 5th 2023 with its most recent update occurring on August 10th 2023."

Answered by AI

What is the participant recruitment rate for this clinical trial?

"Affirmative. Evident on clinicaltrials.gov is the fact that this medical trial, which was posted on June 5th 2023, remains actively recruiting participants. A total of 300 patients are being sought from a single location."

Answered by AI

Has Melatonin Arm attained the federal approval of the FDA?

"As the Melatonin Arm is currently in Phase 3 trials, there exists both evidence of efficacy and a history of safety; thus, it earned a score of 3 on our team's scale."

Answered by AI

What other investigations have been launched to evaluate Melatonin Arm?

"Presently, 20 Melatonin Arm studies are active with 4 in Phase 3. Participants can find research sites across the US; 23 locations offer clinical trials for this medicine, including Houston, Texas."

Answered by AI

Is this trial a pioneering endeavor?

"At present, 11 cities across 9 nations are running 20 live trials with Melatonin Arm. The pioneering trial for this drug took place in 2007 and was sponsored by Eli Lilly & Company; it involved a sample size of 20 participants and concluded its pre-drug approval stage. Since then, 166 different studies have been conducted using the same medication."

Answered by AI

Are my qualifications satisfactory for enrolling in this research study?

"This trial is seeking 300 participants with acute kidney injury that are aged 18 to 65. Essential criteria for enrolment include being prescribed vancomycin and piperacillin/tazobactam, with the intention of continuing therapy for at least 3 days; a single dose of antibiotics must be administered prior to consenting in order to ensure an ethical study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Melatonin for Prevention of Kidney Injury

Luigi Brunetti 2023. "Melatonin for Prevention of Kidney Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05084196.

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