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Imlifidase Desensitization for Kidney Transplant Patients (ConfIdeS Trial)
ConfIdeS Trial Summary
This trial is testing whether a new treatment can help kidney transplant patients with high levels of antibodies to get a kidney from a deceased donor.
ConfIdeS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowConfIdeS 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 2020 Phase 2 trial • 15 Patients • NCT03157037ConfIdeS Trial Design
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Who is running the clinical trial?
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- The doctor thinks I might not be able to take part in the trial for some reason.I have severe kidney disease, am highly sensitized, and waiting for a donor kidney.I am using or willing to use two effective birth control methods if I can have children.I have a confirmed condition that causes excessive blood clotting.I haven't taken any experimental drugs recently.I do not have severe heart issues, unstable heart disease, or severe COPD needing oxygen.I received a high dose IVIg treatment within the last 28 days.I have or had TTP, or it runs in my family.I show signs of CMV or EBV infection.I am between 18 and 70 years old.I show signs of hepatitis B or C infection.I have active tuberculosis.I am willing to participate in a trial for 4 more years.I have been treated with imlifidase before.
- Group 1: Imlifidase
- Group 2: Best available treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does this study include middle-aged adults as participants?
"According to the age requirements set out in this study's inclusion criteria, the youngest patients that can participate are 18 years old while the oldest are 70."
Is this research looking for more participants?
"The listing on clinicaltrials.gov verifies that this trial is still recruiting patients. The study was created on October 14th, 2021 and edited for the last time on July 13th, 2022. So far, 64 individuals have been enrolled at 11 different sites."
Could you tell me how many different hospitals are participating in this trial at the moment?
"Enrollment for this research is currently underway at 11 sites which are situated in cities such as San Antonio, Birmingham and Baltimore. You can refer to the study website to find the full list of locations and select the one that is most convenient for you."
Would I be eligible to help with this research?
"The prerequisites for enrolment in this clinical trial are that patients must have kidney disease and be between 18-70 years old. So far, 64 individuals have been admitted to the study."
What other research studies have there been on Imlifidase?
"Imlifidase was first researched in 1993 at National Institutes of Health Clinical Centre. Since then, there have been 1015 completed trials with 469 currently active ones. The majority of these ongoing trials are based in San Antonio, Texas."
Is Imlifidase a danger to patients?
"Imlifidase's safety rating is 3. This means that, while Phase 3, there is data to support efficacy as well as multiple rounds of supportive safety data."
What is the main disease that Imlifidase has been shown to help with?
"Imlifidase is most commonly used to make a deceased donor's organs compatible with a positive crossmatch patient. It can also treat other conditions such as b-cell lymphomas, polyangium, neuromyelitis optica."
What is the maximum amount of participants that can be in this study?
"To move forward, this study requires the recruitment of 64 individuals that meet a set of specific inclusion criteria. Potential participants can inquire about the trial at locations such as Methodist Hospital Specialty and Transplant in San Antonio, Texas or University of Alabama at Birmingham (UAB) Hospital in Birmingham, Alabama."
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