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Anifrolumab for Lupus Nephritis (IRIS Trial)
IRIS Trial Summary
This trial will test a new drug, antifrolumab, to see if it is effective and safe in treating patients with lupus nephritis.
IRIS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowIRIS 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 2018 Phase 3 trial • 373 Patients • NCT02446899IRIS Trial Design
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Who is running the clinical trial?
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- I have only had skin cancer or early-stage cervical cancer, which were cured.Your kidney function, as measured by a calculation called eGFR, is at least 35 mL/min/1.73 m2.You have evidence of hepatitis C or have active hepatitis B.You meet the updated 2019 criteria for diagnosing systemic lupus erythematosus (SLE).I have had a severe case of COVID-19.You had a kidney biopsy in the 6 months before joining the study or during the screening period.You have a specific type of kidney disease called lupus nephritis that is actively getting worse.The ratio of protein to creatinine in your urine is higher than 1 mg/mg (113.17 mg/mmol).I have a condition that makes me more prone to infections or I am HIV positive.You cannot tolerate taking 1.0 gram or less of MMF per day.I have had more than two experimental treatments for lupus since my diagnosis.I have no symptoms or treatment history for active or latent TB.I am currently taking medication for my lupus flare-up.You have been diagnosed with pure Class V lupus nephritis based on a kidney biopsy taken within the last 6 months.
- Group 1: Anifrolumab
- Group 2: Placebo
- 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
To whom does this trial open enrollment?
"In order to be an eligible candidate for this study, patients must suffer from lupus nephritis and fall in the age range of 18 to 70. Up to 360 people can take part in the clinical trial."
How many people are currently participating in this experiment?
"That is correct. The information on clinicaltrials.gov does state that this trial is actively recruiting participants. The trial was first posted on February 15th, 2022 and was last updated on November 2nd, 2022. The study is looking for 360 patients at 12 different sites."
Anifrolumab - is it a risky treatment for patients?
"Anifrolumab is a safe medication, as evidenced by its Phase 3 clinical trial status. This means that not only is there some data supporting its efficacy, but also that there are multiple rounds of data supporting its safety."
Is this research on Anifrolumab preliminary or have there been other investigations into this drug?
"There are three ongoing clinical trials for Anifrolumab, and of those three, one is in Phase 3. Wuhan, New york, and 307 other locations across the world are running these trials."
On how many different websites can I find this trial?
"There are 12 enrolment locations for this trial, situated in Las Cruces, Hallandale Beach, Plantation, and 9 other places. The investigators conducting the study recommend that patients choose the closest trial site to minimize travel."
Are scientists still looking for participants for this experiment?
"This is an active trial, as seen on clinicaltrials.gov. The listing was created on February 15th, 2022 and was last updated less than a month ago on November 2nd, 2022."
Has this type of research been conducted before?
"Research for Anifrolumab began in 2021 and the first 360-person study was sponsored by AstraZeneca. This trial led to Anifrolumab being approved as a Phase 3 drug. Currently, 3 trials are underway in 40 cities and 28 countries."
Does the age restriction for this clinical trial begin at 35 years old?
"Eligible participants for this particular study must fall between 18-70 years old. There are 9 corresponding clinical trials for minors and 35 for elderly patients."
Who else is applying?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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