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Ravulizumab for Kidney Damage from Heart Surgery (ARTEMIS Trial)
ARTEMIS Trial Summary
This trial studies the effects of a single dose of a drug to reduce the risk of kidney damage from heart surgery.
ARTEMIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowARTEMIS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 195 Patients • NCT03056040ARTEMIS Trial Design
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Who is running the clinical trial?
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- I have not used kidney replacement therapy or had acute kidney injury in the last 30 days.I weigh at least 30 kilograms.I haven't used complement inhibitors or undergone plasmapheresis in the last year.I am scheduled for a single-vessel bypass surgery without any valve procedures.I have been diagnosed with moderate to severe kidney disease for at least 3 months.My surgery is planned without using a heart-lung machine.I have received a solid organ or bone marrow transplant.I have not had a serious infection in the last 14 days.I have not used heart support devices or had severe heart issues in the last 3 days.I am scheduled for heart surgery that may include bypass or valve repair.I often get infections without any known cause.I am willing to get vaccinated against N meningitidis and take antibiotics if needed.You have had a past infection with N meningitidis that has not been fully treated.I am expected to need emergency heart surgery soon.
- Group 1: Placebo
- Group 2: Ravulizumab
- 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
Has Ravulizumab received official sanction from the FDA?
"Our team's assessment of Ravulizumab's safety earned it a score of 3, since the Phase 3 trial results have demonstrated its effectiveness and there is ample evidence supporting its security."
Is enrollment for this research investigation still open?
"Data from clinicaltrials.gov reveals that, as of February 27th 2023, this research is not actively enrolling patients. Despite this, there are still 850 other studies seeking participants at the present time."
Are participants of this trial restricted to a certain age limit?
"This medical trial requires that participants are between the ages of 18 to 90. Conversely, there is an additional 130 trials for people under eighteen and 734 studies available for those who are elderly."
What are the geographic locations in which this clinical trial is being conducted?
"At present, 84 medical centres across the United States are participating in this trial. In addition to Washington, Gainesville and Chicago, many other cities have clinics open for recruitment. It is advised that participants select a local clinic to minimize travel requirements."
Am I eligible to be a part of this clinical investigation?
"Patients must have chronic kidney disease, a minimum age of 18 and be no older than 90 to qualify for this trial. There are 736 participants being enrolled in total."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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