Kidney Transplantation in Highly Sensitized PatientsPhase 3ConfIdeSNCT04935177
Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx
A Phase 3 study testing Imlifidase, PLEX and IVIg in people with Kidney Transplantation in Highly Sensitized Patients, run by Hansa Biopharma AB at 25 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplantation in Highly Sensitized Patients
- What is being tested?
- Imlifidase, PLEX and IVIg
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 25 sitesUnited States
- Study dates
- 14 Oct 2021to 20 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 18Show fewer
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
John Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, 35249
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
Houston Methodist Hospital
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Keck Hospital of University of Southern California (USC)
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
New York University (NYU) Langone Transplant Institute, NYU Langone Health
New York, New York, 10016
Columbia University
New York, New York, 10032
New York-Presbyterian - Weill Cornell Medical Center
New York, New York, 10065
Hospital of the University of Pennsylvania, Penn Medicine
Philadelphia, Pennsylvania, 19104
Banner Health - University Medical Center - Phoenix
Phoenix, Arizona, 85006
Mayo Clinic Phoenix
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Methodist Hospital Specialty and Transplant
San Antonio, Texas, 78229
Sutter Health - California Pacific Medical Center
San Francisco, California, 94115
University of California San Francisco (UCSF) Medical Center
San Francisco, California, 94143-0780
University of Washington Medical Center
Seattle, Washington, 98195
Washington University School of Medicine
St Louis, Missouri, 63110
Georgetown Transplant Institute
Washington D.C., District of Columbia, 20007
About this study
Official title: 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
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
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo pre-screening to determine eligibility for study entry.
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.
- Being tested
- Imlifidase, PLEX, IVIg, Anti-CD20 antibodies, Eculizumab
- Keywords
- Desensitization, Highly sensitized, Positive crossmatch, Unlikely to be transplanted, Renal transplantation, Deceased donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImlifidaseDrug
Also called IdeS, HMED-IdeS
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.
PLEXProcedure or surgery
Also called Plasma exchange, PE
PLEX is performed according to the respective site's standard procedure for desensitization.
IVIgDrug
Also called Intravenous immunoglobulin
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 antibodiesDrug
Also called Rituximab
Rituximab and other anti-CD20 according to the respective site's standard procedure for desensitization.
EculizumabDrug
Also called Soliris
Eculizumab according to the respective site's standard procedure for desensitization.
Remain on wait listOther
Remain on wait list for a more compatible organ offer if desentization with institutional protocol is not appropriate
| Study group | Role | What they receive |
|---|---|---|
| Imlifidase | Experimental | 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. Receives: Drug: Imlifidase |
| Best available treatment | Other | 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 Receives: Procedure: PLEX; Drug: IVIg; Drug: Anti-CD20 antibodies; Drug: Eculizumab; Other: Remain on wait list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after randomization
Secondary outcomes (1)
Patient survival at 12 months
Patient survival will be summarized by end of trial and compared between treatment arms.
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start14 Oct 2021
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplantation in Highly Sensitized PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, controlled and randomized
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hansa Biopharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Operations, Study director, Hansa Biopharma AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935177
- Sponsor's protocol ID
- 20-HMedIdeS-17
- Acronym
- ConfIdeS
- Status last verified
- Apr 2026
- First submitted
- 14 Jun 2021
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04935177
- Acronym / sponsor ID
- ConfIdeS / 20-HMedIdeS-17
- Keywords
- Desensitization, Highly sensitized, Positive crossmatch, Unlikely to be transplanted, Renal transplantation, Deceased donor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hansa Biopharma ABIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo pre-screening to determine eligibility for study entry.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, controlled and randomized
| Arm | Type | Receives |
|---|---|---|
| Imlifidase | Experimental | Drug: ImlifidaseImlifidase, 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 | Other | Procedure: PLEX, Drug: IVIg, Drug: Anti-CD20 antibodies, Drug: Eculizumab, Other: Remain on wait listInstitution-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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImlifidaseAlso: IdeS, HMED-IdeSImlifidase 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. | Drug | Imlifidase |
| PLEXAlso: Plasma exchange, PEPLEX is performed according to the respective site's standard procedure for desensitization. | Procedure or surgery | Best available treatment |
| IVIgAlso: Intravenous immunoglobulinIVIg 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. | Drug | Best available treatment |
| Anti-CD20 antibodiesAlso: RituximabRituximab and other anti-CD20 according to the respective site's standard procedure for desensitization. | Drug | Best available treatment |
| EculizumabAlso: SolirisEculizumab according to the respective site's standard procedure for desensitization. | Drug | Best available treatment |
| Remain on wait listRemain on wait list for a more compatible organ offer if desentization with institutional protocol is not appropriate | Other | Best available treatment |
Primary outcome
Mean estimated glomerular filtration rate (eGFR) at 12 months
Time frame: 12 months after randomization
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.
1 secondary outcome
Patient survival at 12 months
Time frame: 12 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Operations study director
Hansa Biopharma AB
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imlifidase, PLEX and IVIg in people with Kidney Transplantation in Highly Sensitized Patients, run by Hansa Biopharma AB at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean estimated glomerular filtration rate (eGFR) at 12 months (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.