Kidney Transplantation in Highly Sensitized PatientsPhase 2DINKYNCT05753930
Imlifidase Prior to Kidney Transplant in Highly Sensitised Children
A Phase 2 study testing Imlifidase in people with Kidney Transplantation in Highly Sensitized Patients, run by Hansa Biopharma AB at 6 sites in 5 countries.
Trial summary
The goal of this clinical trial is to learn about the efficacy and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD). Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Kidney Transplantation in Highly Sensitized Patients
- What is being tested?
- Imlifidase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 6 sitesin 5 countries
- Study dates
- 2 Jun 2023to 31 Aug 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed Informed Consent obtained from patient/parent/legal guardian/independent witness (depending on patient's age) before any trial-related procedures
- Highly sensitised patient with panel reactive antibodies (PRA) ≥80%
- Male or female patient between the age of 1 to 17 years (up to the day before the 18th birthday) at the time of screening
- Patient with end-stage renal disease (ESRD) and waiting for a renal transplant from a living or deceased donor
- Patient must be transplantable (including size mismatch) at the time of obtaining informed consent for trial participation
- Patients who have previously undergone desensitisation unsuccessfully with plasmapheresis/IVIg/anti-CD20 or have an anti-HLA antibody status deemed too difficult to make a successful desensitisation (judgement based on physicians' previous experience with similar patients)
- Positive crossmatch (XM) test determined by flow cytometry crossmatch (FCXM) and/or complement-dependent cytotoxicity crossmatch (CDCXM) tests against the donor. For the DD patients, if physical XM tests are not practically possible due to lack of time, patients may be included on a virtual crossmatch (vXM) predictive of a positive XM test.
- Willingness and ability to comply with the protocol as judged by the investigator
Who cannot join
- Previous treatment with imlifidase
- IVIg treatment within 28 days prior to imlifidase treatment
- Desensitisation treatment(s) within 1 month prior to the current transplantation
- Hypersensitivity to the active substance (imlifidase) or to any of the excipients and to other immunosuppressive drugs specified in the protocol
- Ongoing serious infections
- Present, or history of, thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
Show all 22Show fewer
- At the time of transplantation: severe other condition requiring treatment and close monitoring e.g. cardiac failure ≥ grade 4 (New York Heart Association), unstable coronary disease, active peripheral vascular disease, proven hypercoagulable conditions/events or oxygen dependent respiratory disease
- Malignancy within 3 years prior to transplantation
- ABO blood group incompatible transplantations (A2 and A2B kidneys will not be accepted for B recipients)
- Any other reason that, in the view of the investigator, precludes transplantation
- Breast feeding or pregnancy, if applicable
- Woman of fertile age and sexually active without adequate contraceptive measures to avoid pregnancy during the interventional trial period (i.e. up to 6 months after transplantation)
- Suspicion of Covid-19 infection or positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test
- Positive serology for human immunodeficiency virus (HIV)
- Clinical signs of hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus (CMV), or Epstein Barr virus (EBV) infection
- Donor with positive serology for HIV, HBV, HCV or CMV to a patient with negative serology (mismatch serology). Mismatch serology for EBV in accordance with center specific standard procedures for transplantation of EBV negative recipients and at investigator's discretion.
- Clinically relevant active infection(s) as judged by the investigator
- Tuberculosis or history of tuberculosis
- Use of other investigational agents within 5 terminal elimination half-lives prior to the transplantation
- Contemporaneous participation in medical device studies
- Known mental incapacity or language barriers precluding patients'/parents'/legal guardians' 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
6 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 5 countries
Spain2 sites, 2 recruiting
- Recruiting
Hospital Unviersitari Vall d'Hebron, Nefrología Pediátrica
Barcelona, 08035
Gema Ariceta, MD, gema.ariceta@vallhebron.cat
Gema Ariceta, MD
- Not yet recruiting
Hospital Sant Joan De Deu Barcelona
Barcelona, 08950
Yolanda Calzada, MD, frecerca.startup@sjd.es
Yolanda Calzada, MD
France1 site, 1 recruiting
- Recruiting
Robert Debre University Hospital
Paris, 75019
Julien Hogan, Professor, julien.hogan2@aphp.fr
Julien Hogan, Professor
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Huddinge, Stockholm County, SE-141 86
L Wennberg, MD, Lars.Wennberg@regionstockholm.se
L Wennberg, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH
S Marks, MD
S Marks, MD
About this study
Official title: A Single-arm, Multi-centre Trial to Evaluate Efficacy and Safety of Imlifidase in Highly Sensitised Children (1-17 Years) Receiving a Kidney Transplant With Positive Crossmatch Against a Living or Deceased Donor Converted to Negative After Imlifidase Treatment
The goal of this clinical trial is to learn about the efficacy and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD).
The main questions it aims to answer are:
- Does imlifidase treatment result in crossmatch conversion that enables transplantation?
- How is the function of the transplanted kidney?
The participants will be hospitalised in accordance with the normal routines for transplanted patients. The patients will receive medication to prevent rejection of the donor kidney, and because such treatment make the body more vulnerable medications to prevent infections.
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.
The trial will include highly sensitised ESRD paediatric patients (1-17 years). The patients have previously undergone desensitization unsuccessfully or have an anti-HLA antibody status deemed too difficult to make a successful desensitization using other experimental methods.
A screening visit will take place when an organ offer has been placed for a final check of the patients' eligibility for study participation.
All patients included in the trial will be desensitized with imlifidase to convert the positive XM to negative and then transplanted with either a kidney from a deceased donor (DD) or a living donor (LD).
Patients will be hospitalised in accordance with the normal routines for transplanted patients at each clinic.
Following transplantation, the patients will receive induction therapies, rejection prophylaxis, and maintenance immunosuppressive therapies.
The patients will be closely monitored for any signs of antibody-mediated rejections (AMRs).
The duration of the interventional trial period after an organ has been offered will be 6 months for each patient. The trial includes a follow-up part to collect long-term efficacy and safety data up to 5 years after the transplantation.
- Being tested
- Imlifidase
- Keywords
- Desensitization, Highly sensitized, Positive crossmatch, Unlikely to be transplanted, Kidney transplantation, Deceased donor, Living donor, End-Stage Renal Disease, Paediatric patients, Children, Incompatible transplant
- Medical subject headings
- Kidney Failure, Chronic
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.
| Study group | Role | What they receive |
|---|---|---|
| Imlifidase | Experimental | Imlifidase is administered intravenously as one infusion of 0.25 mg/kg over 15 minutes within 24 hours prior to transplantation. Receives: Drug: Imlifidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with conversion of a positive crossmatch test to negative within 24 hours after start of imlifidase treatment
Immunoglobulins (IgG) including donor specific antibodies (DSAs) are rapidly and efficiently cleaved by imlifidase. A conversion of a positive to a negative XM will enable transplantation.
Measured: From start of imlifidase administration to 24 hours
Secondary outcomes (21)
Renal function up to 5 years after transplantation as assessed by estimated glomerular filtration rate (eGFR)
eGFR is a measure of kidney function. Reduced kidney function is characterised by a decreased eGFR value.
Measured: From pre-dose imlifidase up to 5 years
Renal function up to 5 years after transplantation as assessed by serum/plasma creatinine levels
Creatinine is a measure of kidney function. Reduced kidney function is characterised by an increased value.
Measured: From pre-dose imlifidase up to 5 years
Renal function up to 5 years after transplantation as assessed by serum/plasma cystatin C levels
Cystatin C is a measure of kidney function. Reduced kidney function is characterised by an increased value.
Measured: From pre-dose imlifidase up to 5 years
Renal function up to 5 years after transplantation as assessed by proteinuria
Proteinuria (protein/creatinine ratio in urine) is a measure of kidney function. Reduced kidney function is characterised by an increased value.
Measured: From pre-dose imlifidase up to 5 years
DSA levels up to 5 years after transplantation
Donor specific antibodies (DSAs) are antibodies in the recipient directed against the transplanted organ.
Measured: From pre-dose imlifidase up to 5 years
Graft survival (death censored) up to 5 year after transplantation
Measured: From 6 months up to 5 years
Graft failure-free survival up to 5 years after transplantation
Measured: From 6 months up to 5 years
Patient survival up to 5 years after transplantation
Measured: From 6 months up to 5 years
Frequency of delayed graft function (DGF)
DGF is defined as 'Need for dialysis within 7 days of transplantation' in "Delayed graft function in kidney transplantation: developing drugs for prevention, guidance for industry", FDA 2019.
Frequency of patients having DGF in accordance with this definition will be presented.
Measured: From transplantation up 7 days after transplantation
Length of DGF
DGF is defined as 'Need for dialysis within 7 days of transplantation' in "Delayed graft function in kidney transplantation: developing drugs for prevention, guidance for industry", FDA 2019.
The duration of DGFs in accordance with this definition will be presented.
Measured: From transplantation up 7 days after transplantation
Proportion of patients with dialysis dependency up to 5 years after transplantation
Measured: From 6 months up to 5 years
Imlifidase Pharmacokinetics (AUC)
AUC = Area under the imlifidase plasma concentration versus time curve.
Measured: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacokinetics (Cmax)
Cmax = Maximum observed plasma concentration of imlifidase following dosing.
Measured: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacokinetics (tmax)
tmax = Time point for maximum observed plasma concentration of imlifidase following dosing
Measured: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacokinetics (t1/2)
t1/2 = Terminal half-life of imlifidase.
Measured: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacokinetics (CL)
CL = Clearance of imlifidase.
Measured: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacokinetics (Vz)
Vz = Volume of distribution during the elimination phase
Measured: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacodynamic (PD) profile up to 9 days after imlifidase treatment
PD is assessed as serum concentrations of intact IgG and its fractions following infusion.
Measured: From pre-dose imlifidase up to Day 10
Immunogenicity profile of imlifidase up to 5 years after imlifidase treatment
Immunogenicity is assessed as serum concentration of anti-imlifidase IgG (ADA).
Measured: From pre-dose imlifidase up to 5 years
Proportion of patients with biopsy- and serology (DSA)-confirmed AMR up to 5 years after transplantation
Banff scores (Loupy et al. 2020) will be used for biopsy evaluation.
Measured: From transplantation up to 5 years
Proportion of patients with biopsy confirmed cell-mediated rejection (CMR) up to 5 years after transplantation
Banff scores (Loupy et al. 2020) will be used for biopsy evaluation.
Measured: From transplantation up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start2 Jun 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, non-randomised trial in highly sensitized paediatric kidney transplant patients with positive XM against an available DD or LD. The rationale for a non-randomised trial in DD kidney transplantation is that there are no other effective or approved desensitisation protocols that would provide a suitable or ethical control. The rationale for a non-randomised trial in LD kidney transplantation is that potential control treatments have already been tried unsuccessfully in the patients or such treatments are judged as highly unlikely to succeed based on the breadth and depth of the patients' sensitisation. Treatment with little anticipation of success would expose the patients to unnecessary immunosuppression.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
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
- NCT05753930
- Sponsor's protocol ID
- 20-HMedIdes-21
- Other IDs
- 2022-500230-28-00
- Acronym
- DINKY
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Loupy A, Haas M, Roufosse C, Naesens M, Adam B, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell LD, Clahsen-van Groningen MC, Demetris AJ, Dragun D, Duong van Huyen JP, Farris AB, Fogo AB, Gibson IW, Glotz D, Gueguen J, Kikic Z, Kozakowski N, Kraus E, Lefaucheur C, Liapis H, Mannon RB, Montgomery RA, Nankivell BJ, Nickeleit V, Nickerson P, Rabant M, Racusen L, Randhawa P, Robin B, Rosales IA, Sapir-Pichhadze R, Schinstock CA, Seron D, Singh HK, Smith RN, Stegall MD, Zeevi A, Solez K, Colvin RB, Mengel M. The Banff 2019 Kidney Meeting Report (I): Updates on and clarification of criteria for T cell- and antibody-mediated rejection. Am J Transplant. 2020 Sep;20(9):2318-2331. doi: 10.1111/ajt.15898. Epub 2020 May 28.
PubMed 32463180
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Multi-centre Trial to Evaluate Efficacy and Safety of Imlifidase in Highly Sensitised Children (1-17 Years) Receiving a Kidney Transplant With Positive Crossmatch Against a Living or Deceased Donor Converted to Negative After Imlifidase Treatment
- ClinicalTrials.gov ID
- NCT05753930
- Acronym / sponsor ID
- DINKY / 20-HMedIdes-21
- Keywords
- Desensitization, Highly sensitized, Positive crossmatch, Unlikely to be transplanted, Kidney transplantation, Deceased donor, Living donor, End-Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hansa Biopharma ABIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 3 Mar 2023 (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.
The goal of this clinical trial is to learn about the efficacy and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD).
The main questions it aims to answer are:
- Does imlifidase treatment result in crossmatch conversion that enables transplantation?
- How is the function of the transplanted kidney?
The participants will be hospitalised in accordance with the normal routines for transplanted patients. The patients will receive medication to prevent rejection of the donor kidney, and because such treatment make the body more vulnerable medications to prevent infections.
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.
The trial will include highly sensitised ESRD paediatric patients (1-17 years). The patients have previously undergone desensitization unsuccessfully or have an anti-HLA antibody status deemed too difficult to make a successful desensitization using other experimental methods.
A screening visit will take place when an organ offer has been placed for a final check of the patients' eligibility for study participation.
All patients included in the trial will be desensitized with imlifidase to convert the positive XM to negative and then transplanted with either a kidney from a deceased donor (DD) or a living donor (LD).
Patients will be hospitalised in accordance with the normal routines for transplanted patients at each clinic.
Following transplantation, the patients will receive induction therapies, rejection prophylaxis, and maintenance immunosuppressive therapies.
The patients will be closely monitored for any signs of antibody-mediated rejections (AMRs).
The duration of the interventional trial period after an organ has been offered will be 6 months for each patient. The trial includes a follow-up part to collect long-term efficacy and safety data up to 5 years after the transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, non-randomised trial in highly sensitized paediatric kidney transplant patients with positive XM against an available DD or LD. The rationale for a non-randomised trial in DD kidney transplantation is that there are no other effective or approved desensitisation protocols that would provide a suitable or ethical control. The rationale for a non-randomised trial in LD kidney transplantation is that potential control treatments have already been tried unsuccessfully in the patients or such treatments are judged as highly unlikely to succeed based on the breadth and depth of the patients' sensitisation. Treatment with little anticipation of success would expose the patients to unnecessary immunosuppression.
| Arm | Type | Receives |
|---|---|---|
| Imlifidase | Experimental | Drug: ImlifidaseImlifidase is administered intravenously as one infusion of 0.25 mg/kg over 15 minutes within 24 hours prior to transplantation. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Signed Informed Consent obtained from patient/parent/legal guardian/independent witness (depending on patient's age) before any trial-related procedures
- Highly sensitised patient with panel reactive antibodies (PRA) ≥80%
- Male or female patient between the age of 1 to 17 years (up to the day before the 18th birthday) at the time of screening
- Patient with end-stage renal disease (ESRD) and waiting for a renal transplant from a living or deceased donor
- Patient must be transplantable (including size mismatch) at the time of obtaining informed consent for trial participation
Key exclusion criteria (22 listed)
- Previous treatment with imlifidase
- IVIg treatment within 28 days prior to imlifidase treatment
- Desensitisation treatment(s) within 1 month prior to the current transplantation
- Hypersensitivity to the active substance (imlifidase) or to any of the excipients and to other immunosuppressive drugs specified in the protocol
- Ongoing serious infections
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 |
Primary outcome
Proportion of patients with conversion of a positive crossmatch test to negative within 24 hours after start of imlifidase treatment
Time frame: From start of imlifidase administration to 24 hours
Immunoglobulins (IgG) including donor specific antibodies (DSAs) are rapidly and efficiently cleaved by imlifidase. A conversion of a positive to a negative XM will enable transplantation.
21 secondary outcomes
Renal function up to 5 years after transplantation as assessed by estimated glomerular filtration rate (eGFR)
Time frame: From pre-dose imlifidase up to 5 years
Renal function up to 5 years after transplantation as assessed by serum/plasma creatinine levels
Time frame: From pre-dose imlifidase up to 5 years
Renal function up to 5 years after transplantation as assessed by serum/plasma cystatin C levels
Time frame: From pre-dose imlifidase up to 5 years
Renal function up to 5 years after transplantation as assessed by proteinuria
Time frame: From pre-dose imlifidase up to 5 years
DSA levels up to 5 years after transplantation
Time frame: From pre-dose imlifidase up to 5 years
Graft survival (death censored) up to 5 year after transplantation
Time frame: From 6 months up to 5 years
Graft failure-free survival up to 5 years after transplantation
Time frame: From 6 months up to 5 years
Patient survival up to 5 years after transplantation
Time frame: From 6 months up to 5 years
Frequency of delayed graft function (DGF)
Time frame: From transplantation up 7 days after transplantation
Length of DGF
Time frame: From transplantation up 7 days after transplantation
Proportion of patients with dialysis dependency up to 5 years after transplantation
Time frame: From 6 months up to 5 years
Imlifidase Pharmacokinetics (AUC)
Time frame: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacokinetics (Cmax)
Time frame: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacokinetics (tmax)
Time frame: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacokinetics (t1/2)
Time frame: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacokinetics (CL)
Time frame: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacokinetics (Vz)
Time frame: From pre-dose imlifidase up to Day 15
Imlifidase Pharmacodynamic (PD) profile up to 9 days after imlifidase treatment
Time frame: From pre-dose imlifidase up to Day 10
Immunogenicity profile of imlifidase up to 5 years after imlifidase treatment
Time frame: From pre-dose imlifidase up to 5 years
Proportion of patients with biopsy- and serology (DSA)-confirmed AMR up to 5 years after transplantation
Time frame: From transplantation up to 5 years
Proportion of patients with biopsy confirmed cell-mediated rejection (CMR) up to 5 years after transplantation
Time frame: From transplantation up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 32463180Loupy A, Haas M, Roufosse C, Naesens M, Adam B, Afrouzian M, Akalin E, Alachkar N, Bagnasco S, Becker JU, Cornell LD, Clahsen-van Groningen MC, Demetris AJ, Dragun D, Duong van Huyen JP, Farris AB, Fogo AB, Gibson IW, Glotz D, Gueguen J, Kikic Z, Kozakowski N, Kraus E, Lefaucheur C, Liapis H, Mannon RB, Montgomery RA, Nankivell BJ, Nickeleit V, Nickerson P, Rabant M, Racusen L, Randhawa P, Robin B, Rosales IA, Sapir-Pichhadze R, Schinstock CA, Seron D, Singh HK, Smith RN, Stegall MD, Zeevi A, Solez K, Colvin RB, Mengel M. The Banff 2019 Kidney Meeting Report (I): Updates on and clarification of criteria for T cell- and antibody-mediated rejection. Am J Transplant. 2020 Sep;20(9):2318-2331. doi: 10.1111/ajt.15898. Epub 2020 May 28.
- 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.
Clinical Operations study director
Hansa Biopharma AB
6 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imlifidase in people with Kidney Transplantation in Highly Sensitized Patients, run by Hansa Biopharma AB at 6 sites in 5 countries.
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 8 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, Finland, France, Sweden, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Central Contact (+46 46 16 56 70, clinicalstudyinfo@hansabiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with conversion of a positive crossmatch test to negative within 24 hours after start of imlifidase treatment (time frame: From start of imlifidase administration to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05753930, which also lists 1 linked publication.
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 18 Aug 2026.