Breakthrough drug could open door to kidney transplants for 'Impossible' patients
NCT ID NCT04935177
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tested a drug called imlifidase in 64 highly sensitized kidney transplant patients who had almost no chance of finding a compatible donor. The drug breaks down harmful antibodies, allowing a transplant from a donor that would normally be rejected. The study measured kidney function at 12 months and found that imlifidase helped more patients receive a transplant with better kidney function compared to standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Imlifidase (a drug that breaks down antibodies to allow a kidney transplant)
- What this could lead to
- If successful, this could help highly sensitized patients get a kidney transplant they otherwise couldn't, improving kidney function and survival.
- What could go wrong
- This is a small, early-phase trial with only 64 participants. The drug may not work for everyone, and there are risks like infection or rejection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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64 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Signed Informed Consent obtained before any trial-related procedures * Male or female age 18-70 years at the time of screening * Chronic kidney disease (CKD) stage 5, highly sensitized as evaluated by standard selection criteria, and active on the OPTN waiting list for a DD kidney transplant * Original calculated panel reactive antibody (cPRA) ≥99.9% * Virtual crossmatch (vXM), predictive of a positive crossmatch to an available deceased donor (DD) * Willingness and ability to comply with the protocol * Willingness to participate in the planned 4-year extension trial Exclusion Criteria: * High dose IVIg (2 g/kg) treatment within 28 days prior to imlifidase treatment * Previous treatment with imlifidase * Breast feeding or pregnancy * Women of child-bearing potential not willing or able to practice FDA-approved forms of contraception, or abstinence. Two medically acceptable methods of highly effective contraception must be used for the duration of the study (e.g. oral, transdermal, intravaginal, injectable or implantable contraceptive; intrauterine device; intrauterine hormone-releasing system; vasectomized partner; bilateral tubal occlusion; or double barrier method). For a woman to be considered postmenopausal this ascertainment must be made according to medical records and clinical history and may be aided by measurement of elevated postmenopausal serum gonadotropin levels (FSH). * ABO blood group incompatible transplantations (A2 or A2B kidneys will not be accepted for B recipients) * Positive serology for human immunodeficiency virus (HIV) * Clinical signs of hepatitis B virus (HBV) or hepatitis C virus (HCV) infections * Clinical signs of cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infections * Positive test for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) (according to local hospital routines) * Active tuberculosis * Severe other conditions requiring treatment and close monitoring, e.g. cardiac failure ≥grade 4 (New York Heart Association), unstable coronary disease or oxygen dependent chronic obstructive pulmonary disease (COPD) * Any condition that in the view of the Investigator precludes transplantation * History of a proven hypercoagulable condition * Present or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP * Intake of investigational drugs within 5 half-lives of the drug or 3 months, whichever is the longest * Contemporaneous participation in a medical device study * Known mental incapacity or language barriers precluding adequate understanding of the Informed Consent information and the trial activities * Inability by the judgement of the investigator to participate in the trial for any other reason
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Banner Health - University Medical Center - Phoenix
Phoenix, Arizona, 85006, United States
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Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
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Columbia University
New York, New York, 10032, United States
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Georgetown Transplant Institute
Washington D.C., District of Columbia, 20007, United States
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Hospital of the University of Pennsylvania, Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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John Hopkins Hospital
Baltimore, Maryland, 21287, United States
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Keck Hospital of University of Southern California (USC)
Los Angeles, California, 90033, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mayo Clinic Phoenix
Phoenix, Arizona, 85054, United States
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Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
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Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Methodist Hospital Specialty and Transplant
San Antonio, Texas, 78229, United States
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New York University (NYU) Langone Transplant Institute, NYU Langone Health
New York, New York, 10016, United States
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New York-Presbyterian - Weill Cornell Medical Center
New York, New York, 10065, United States
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Northwestern University
Chicago, Illinois, 60611, United States
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Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
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Sutter Health - California Pacific Medical Center
San Francisco, California, 94115, United States
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University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35249, United States
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University of California San Francisco (UCSF) Medical Center
San Francisco, California, 94143-0780, United States
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University of Chicago Medical Center
Chicago, Illinois, 60637, United States
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
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University of Minnesota Medical School
Minneapolis, Minnesota, 55455, United States
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University of Washington Medical Center
Seattle, Washington, 98195, United States
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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