Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx

Completed · Phase 3

Conditions studied: Kidney Transplantation in Highly Sensitized Patients

In brief

An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care

Key facts

Study ID

NCT04935177

Run by

Hansa Biopharma AB

People needed

64

Starts

2021-10-14

Expected to finish

2025-06-20

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States
• Banner Health - University Medical Center - Phoenix — Phoenix, Arizona, United States
• Mayo Clinic Phoenix — Phoenix, Arizona, United States
• Keck Hospital of University of Southern California (USC) — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Sutter Health - California Pacific Medical Center — San Francisco, California, United States
• University of California San Francisco (UCSF) Medical Center — San Francisco, California, United States
• Georgetown Transplant Institute — Washington D.C., District of Columbia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• John Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota Medical School — Minneapolis, Minnesota, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Saint Barnabas Medical Center — Livingston, New Jersey, United States
• New York University (NYU) Langone Transplant Institute, NYU Langone Health — New York, New York, United States
• Columbia University — New York, New York, United States
• New York-Presbyterian - Weill Cornell Medical Center — New York, New York, United States
• Hospital of the University of Pennsylvania, Penn Medicine — Philadelphia, Pennsylvania, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Methodist Hospital Specialty and Transplant — San Antonio, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.