Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx
NCT ID: NCT04935177
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
64 participants
INTERVENTIONAL
2021-10-14
2025-06-20
Brief Summary
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Detailed Description
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Once an organ offer is received, a virtual crossmatch (vXM) is performed. If the crossmatch is considered predictive of a positive flow cytometry crossmatch (FCXM), the patient will be evaluated if eligible to receive the desensitization currently in use at the study site. Subsequently the patient will be randomized in a 1:1 ratio to the imlifidase or the control arm.
If the patient is randomized to the imlifidase arm, the organ will be accepted and shipped, and the patient will proceed to imlifidase treatment (generally within 24 h prior to transplantation) followed by transplantation. If the patient is randomized to the control arm, transplantation made possible by the local desensitization regimen will occur. If the institution-specific desensitization protocol is deemed not to be successful, the organ offer will be turned down, and the patient will remain active on the waiting list and remain in the trial, while the kidney will be allocated to another recipient through the kidney allocation system (KAS).
All transplanted patients will receive induction therapy and maintenance immunosuppression. All patients will be followed for 12 months.
Estimated glomerular filtration rate (eGFR) will be assessed 12 months after randomization as the primary endpoint reasonably likely to predict a clinical benefit in patient survival.
All patients with donor specific antibodies (DSA) are at risk of developing antibody-mediated rejection (AMR). Imlifidase removes DSA quickly and efficiently at the time of transplantation but, as with other desensitization methods, the antibodies are expected to re-occur after transplantation. In the imlifidase treatment arm, and for desensitized control arm patients, protocol kidney biopsies will be performed at the time of transplantation and at 1 year after transplantation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Imlifidase
Imlifidase, is provided as a freeze-dried powder for concentrate for solution for infusion, 11 mg per vial. After reconstitution with sterile water for injection, the concentrate contains 10 mg/mL imlifidase. Imlifidase is administered intravenously as one infusion of 0.25 mg/kg over 15 minutes generally 24 hours prior to transplantation. A second dose of 0.25 mg/kg may be given if the first imlifidase dose is considered not to have had sufficient effect.
Imlifidase
Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG.
Best available treatment
Institution-specific desensitization protocol (i.e. any combination of plasma exchange (PLEX), intravenous IVIg, anti-CD20 antibody, and eculizumab) where appropriate OR remain on wait list for a more compatible organ offer
PLEX
PLEX is performed according to the respective site's standard procedure for desensitization.
IVIg
IVIg prepared from a pool of immunoglobulins from the plasma of thousands of healthy donors is administered in accordance with respective site's standard procedure for desensitization.
Anti-CD20 antibodies
Rituximab and other anti-CD20 according to the respective site's standard procedure for desensitization.
Eculizumab
Eculizumab according to the respective site's standard procedure for desensitization.
Remain on wait list
Remain on wait list for a more compatible organ offer if desentization with institutional protocol is not appropriate
Interventions
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Imlifidase
Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly selective towards IgG. The cleavage of IgG generates one F(ab')2- and one homodimeric Fc-fragment and efficiently neutralizes Fc-mediated activities of IgG.
PLEX
PLEX is performed according to the respective site's standard procedure for desensitization.
IVIg
IVIg prepared from a pool of immunoglobulins from the plasma of thousands of healthy donors is administered in accordance with respective site's standard procedure for desensitization.
Anti-CD20 antibodies
Rituximab and other anti-CD20 according to the respective site's standard procedure for desensitization.
Eculizumab
Eculizumab according to the respective site's standard procedure for desensitization.
Remain on wait list
Remain on wait list for a more compatible organ offer if desentization with institutional protocol is not appropriate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Hansa Biopharma AB
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Operations
Role: STUDY_DIRECTOR
Hansa Biopharma AB
Locations
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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
Countries
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Other Identifiers
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20-HMedIdeS-17
Identifier Type: -
Identifier Source: org_study_id
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