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Melatonin for Acute Kidney Injury
Study Summary
This trial will test if melatonin can reduce kidney injury in hospital patients taking antibiotics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check βYesβ for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 2 trial β’ 40 Patients β’ NCT01114373Trial Design
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Who is running the clinical trial?
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- I am taking vancomycin and expected to continue for at least 3 days.I am between 18 and 75 years old.I have had a kidney injury in the last month.I need medication to raise my blood pressure.I cannot take medications by mouth.My liver enzymes are more than three times the normal limit.My kidney function is low, with a creatinine clearance under 30 mL/min.
- Group 1: Placebo Arm
- Group 2: Melatonin Arm
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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