Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx
ConfIdeS
An Open-label, Controlled, Randomized Phase 3 Trial Evaluating 12-month Kidney Function in Highly Sensitized (cPRA ≥99.9%) Kidney Tx Patients With Positive XM Against a Deceased Donor, Comparing Desensitization Using Imlifidase With SoC
1 other identifier
interventional
64
1 country
25
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2021
Typical duration for phase_3
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2021
CompletedFirst Posted
Study publicly available on registry
June 22, 2021
CompletedStudy Start
First participant enrolled
October 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2025
CompletedApril 30, 2026
April 1, 2026
3.7 years
June 14, 2021
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean estimated glomerular filtration rate (eGFR) at 12 months
eGFR is a measure of kidney function and will be compared between treatment arms. eGFR will be calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. eGFR for a kidney with normal function is 90 mL/min/1.73m2. Kidney disease is characterised by a decreased eGFR value. For randomized patients who do not undergo transplantation, lose their graft or die before 12 months, eGFR will be set to zero, consistent with kidney failure.
12 months after randomization
Secondary Outcomes (1)
Patient survival at 12 months
12 months after randomization
Other Outcomes (21)
Frequency of dialysis dependency at 12 months
12 months after randomization
Graft failure-free survival at 12 months
12 months after randomization
Graft survival at 12 months
12 months after randomization
- +18 more other outcomes
Study Arms (2)
Imlifidase
EXPERIMENTALImlifidase, 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.
Best available treatment
OTHERInstitution-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
Interventions
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 is performed according to the respective site's standard procedure for desensitization.
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.
Rituximab and other anti-CD20 according to the respective site's standard procedure for desensitization.
Eculizumab according to the respective site's standard procedure for desensitization.
Remain on wait list for a more compatible organ offer if desentization with institutional protocol is not appropriate
Eligibility Criteria
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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35249, United States
Banner Health - University Medical Center - Phoenix
Phoenix, Arizona, 85006, United States
Mayo Clinic Phoenix
Phoenix, Arizona, 85054, United States
Keck Hospital of University of Southern California (USC)
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Sutter Health - California Pacific Medical Center
San Francisco, California, 94115, United States
University of California San Francisco (UCSF) Medical Center
San Francisco, California, 94143-0780, United States
Georgetown Transplant Institute
Washington D.C., District of Columbia, 20007, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
John Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
New York University (NYU) Langone Transplant Institute, NYU Langone Health
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
New York-Presbyterian - Weill Cornell Medical Center
New York, New York, 10065, United States
Hospital of the University of Pennsylvania, Penn Medicine
Philadelphia, Pennsylvania, 19104, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Methodist Hospital Specialty and Transplant
San Antonio, Texas, 78229, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Operations
Hansa Biopharma AB
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2021
First Posted
June 22, 2021
Study Start
October 14, 2021
Primary Completion
June 20, 2025
Study Completion
June 20, 2025
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share