Long Term Efficacy and SafetyPhase 3PAES-LTFUNCT05937750
A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group
A Phase 3 study testing Imlifidase administered in the 20-HMedIdeS-19 (PAES) study and Best available treatment administered in the 20-HMedIdeS-19 (PAES) study in people with Long Term Efficacy and Safety, run by Hansa Biopharma AB at 14 sites in 7 countries.
Trial summary
A prospective, post-authorisation long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort. Read more about this study
- Who is it for?
- Ages 19 to 76 years
- Conditions the study is for
- Long Term Efficacy and Safety
- What is being tested?
- Imlifidase administered in the 20-HMedIdeS-19 (PAES) study and Best available treatment administered in the 20-HMedIdeS-19 (PAES) study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 14 sitesin 7 countries
- Study dates
- 3 Jul 2023to 30 Apr 2030
- Phase
- Phase 3
- 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 19 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent obtained before any trial-related procedures
- Willingness and ability to comply with the protocol
- Previously transplanted in the clinical trial 20-HmedIdeS-19 (PAES)
Who cannot join
- Inability by the judgment of the investigator to participate in the trial for other reasons
Trial locations and contacts
14 sites in 7 countries.
14 sites in 7 countries
Spain4 sites
Hospital Del Mar, Servicio de Nefrología
Barcelona, 08003
Hospital Universitario del Vall d´Hebron
Barcelona, 08035
Unidad de Trasplante Renal
Barcelona, 08036
Hospital Universitario 12 De Octubre
Madrid, 28041
France2 sites
Centre Hospitalier Universitaire (CHU) de Rouen - Hôpital de Bois-Guillaume
Bois-Guillaume, Normandy, 76230
Hôpital Necker - Enfants Malades
Paris, 75015
Italy2 sites
Azienda Ospedaliera di Padova
Padova, 35128
Azienda Ospedaliero - Universitaria di Parma
Parma, 43100
Netherlands2 sites
Leiden University Medical Center
Leiden, 2333 ZA
Erasmus University Medical Center
Rotterdam, 3015 GD
Sweden2 sites
Karolinska University Hospital,
Huddinge, Stockholm County, 14157
Uppsala University Hospital
Uppsala, 751 85
About this study
Official title: A Prospective, Post-authorisation Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation, Including a Non-comparative Concurrent Reference Cohort
A prospective, post-authorisation long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort.
Read the detailed description
This is a long-term follow-up trial to the post-authorisation efficacy and safety (PAES) trial (trial 20-HMedIdeS-19). The trial will include patients who participated in the PAES trial and were transplanted with a new kidney after treatment with imlifidase (trial drug) or standard of care medication. Imlifidase is a medicine used to prevent the body from rejecting a newly transplanted kidney and is used before transplantation in adults who have antibodies against the donor kidney and are considered 'highly sensitised' based on a positive crossmatch test.
The purpose of this follow-up trial is to fulfil requirements from the European Medicines Agency (EMA) to continue to evaluate efficacy (kidney function) and safety (side effects) over time, for the patients who were transplanted with a new kidney in the PAES trial. The patients will be followed for up to 5 years after transplantation in the PAES trial to collect valuable long-term data.
- Conditions
- Long Term Efficacy and Safety
- Being tested
- Imlifidase administered in the 20-HMedIdeS-19 (PAES) study, Best available treatment administered in the 20-HMedIdeS-19 (PAES) study
- Keywords
- Renal transplantation, Kidney transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imlifidase administered in the 20-HMedIdeS-19 (PAES) studyDrug
Also called IdeS, HMED-IdeS, Idefirix
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 administered in the 20-HMedIdeS-19 (PAES) studyOther
Normal transplantation routine Transplantation and pre- and post-transplantation therapies in accordance with the clinic's normal transplantation routine.
| Study group | Role | What they receive |
|---|---|---|
| Imlifidase | Experimental | Imlifidase administered in the 20-HMedIdeS-19 (PAES) study Receives: Drug: Imlifidase administered in the 20-HMedIdeS-19 (PAES) study |
| Non-Comparative Concurrent Reference Cohort | Experimental | Best available treatment administered in the 20-HMedIdeS-19 (PAES) study Receives: Other: Best available treatment administered in the 20-HMedIdeS-19 (PAES) study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation (imlifidase cohort only)
Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft.
The 5-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable.
Measured: 5-years after transplantation
Secondary outcomes (16)
Graft failure-free survival (%) up to 5 years after transplantation (non-comparative concurrent reference cohort only)
Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft.
The 5-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable.
Measured: 5-years after transplantation
Graft failure-free survival (%) up to 2 and 3 years after transplantation
Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft.
The 2 and 3-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable.
Measured: 2 and 3-years after transplantation
Renal function as evaluated by estimated Glomerular Filtration Rate (eGFR) and serum/plasma creatinine levels
Kidney function assessed by eGFR and serum/plasma creatinine will be summarised over 5 years for the imlifidase group and the reference cohort.
eGFR is a measure of kidney function. The serum/plasma creatinine levels will be analysed and eGFR will be calculated according to the modification of diet in renal disease (MDRD) equation.
Reduced kidney function is characterised by a decreased eGFR value. For patients in the imlifidase group who are not successfully transplanted, or for any enrolled patients without a functioning graft, their eGFR values will be set to 0 mL/min.
Measured: 2, 3, and 5-years after transplantation
Patient survival (%) after transplantation
Patient survival up to 2, 3 and 5 years, respectively, will be assessed for the imlifidase group and the reference cohort.
The 2, 3, and 5-year patient survival rates will be extracted from Kaplan-Meier curves.
Measured: 2, 3, and 5-years after transplantation
Graft survival (%) after transplantation
Graft survival up to 2, 3 and 5 years, respectively, will be assessed for the imlifidase group and the reference cohort.
Graft survival will be presented with Kaplan-Meier curves. Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients who die will be censored at time of death.
Measured: 2, 3, and 5-years after transplantation
Human Leukocyte Antigen (HLA)/Donor Specific Antibodies (DSA) levels (imlifidase cohort only)
HLA antibodies will be analysed using an IgG single antigen solid-phase immunoassay for class I and class II (SAB-HLA).
Donor specific antibodies (DSAs) are identified by using the human leukocyte antigen (HLA) profile data from the donor and the recipient to identify HLA-mismatches.
The mean fluorescence intensity (MFI) will be summarized for all DSAs with an MFI of ≥1000 at any time during the trial (or the PAES trial).
Measured: 2, 3, and 5-years after transplantation
Anti-drug antibody (ADA) levels (imlifidase cohort only)
Determination of anti-imlifidase IgG (ADA) concentration in serum will be performed centrally using a customised ImmunoCAP to evaluate imlifidase long-term immunogenicity.
Measured: 2, 3, and 5-years after transplantation
Proportion of patients (%) with biopsy- and serology (DSA)-confirmed Antibody Mediated Rejections (AMRs)
For-cause biopsies will be obtained to confirm diagnosis for suspected AMRs in both treatment arms.
The biopsies will be analysed locally and centrally and evaluated according to Banff criteria version 2017 or later.
Measured: 2, 3, and 5-years after transplantation
Proportion of patients (%) with biopsy confirmed Cell-Mediated Rejections (CMRs)
For-cause biopsies will be obtained to confirm diagnosis for suspected CMRs in both treatment arms.
The biopsies will be analysed locally and centrally and evaluated according to Banff criteria version 2017 or later.
Measured: 2, 3, and 5-years after transplantation
Treatment of graft rejections
The number of graft rejection episodes treated with dialysis will be recorded
Measured: 2, 3, and 5-years after transplantation
Treatment of graft rejection
The number of graft rejection episodes treated with plasmapheresis will be recorded
Measured: 2, 3, and 5-years after transplantation
Treatment of graft rejection
The number of graft rejection episodes treated with medication will be recorded
Measured: 2, 3, and 5-years after transplantation
Adverse events (AEs)/serious adverse events (SAEs) suspected to be related to imlifidase treatment (imlifidase cohort only)
AEs/SAEs suspected to be related to imlifidase treatment in the PAES trial will be recorded from the time of signed informed consent for participation in the trial until the last trial visit.
Measured: 2, 3, and 5-years after transplantation
Use of immunosuppressive medication
The patient's use of immunosuppressive medications will be recorded for both cohorts from the time of signed informed consent for participation in the trial until the last trial visit.
Measured: 2, 3, and 5-years after transplantation
Comorbidities
Information about comorbidities that are medically relevant and registered in the patient' medical record will be collected. Medically relevant comorbidities are infections, malignancy, diabetes mellitus and cardiovascular events.
Measured: 2, 3, and 5-years after transplantation
Change in patient reported life participation
The Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health domain "Ability to participate in social roles \& activities, PROMIS-SF-8a" will be used as a measure of the patients' health related quality of life.
The questionnaire includes 8 questions about a persons ability to participate in different social activities and there are 5 different answers to choose from for each question: Never/Rarely/Sometimes/Usually/Always
Measured: 2, 3, and 5-years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start3 Jul 2023
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Efficacy and SafetyStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a long-term follow-up trial following an open-label, non-randomized trial in highly sensitized adult kidney transplant patients with positive crossmatch (XM) against an available deceased donor. The rational for the main trial, 20-HMedIdeS-19 (PAES), being non-randomized is that no other effective or approved desensitization protocol exists in deceased-donor kidney transplantation that would provide a suitable control. A non-comparative concurrent reference cohort from participating sites was included to address differences in-site practice and experience.
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT05937750
- Sponsor's protocol ID
- 20-HMedIdeS-20
- Acronym
- PAES-LTFU
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-authorisation Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation, Including a Non-comparative Concurrent Reference Cohort
- ClinicalTrials.gov ID
- NCT05937750
- Acronym / sponsor ID
- PAES-LTFU / 20-HMedIdeS-20
- Conditions
- Long Term Efficacy and Safety
- Keywords
- Renal transplantation, Kidney transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hansa Biopharma ABIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 10 Jul 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.
A prospective, post-authorisation long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort.
Detailed description
This is a long-term follow-up trial to the post-authorisation efficacy and safety (PAES) trial (trial 20-HMedIdeS-19). The trial will include patients who participated in the PAES trial and were transplanted with a new kidney after treatment with imlifidase (trial drug) or standard of care medication. Imlifidase is a medicine used to prevent the body from rejecting a newly transplanted kidney and is used before transplantation in adults who have antibodies against the donor kidney and are considered 'highly sensitised' based on a positive crossmatch test.
The purpose of this follow-up trial is to fulfil requirements from the European Medicines Agency (EMA) to continue to evaluate efficacy (kidney function) and safety (side effects) over time, for the patients who were transplanted with a new kidney in the PAES trial. The patients will be followed for up to 5 years after transplantation in the PAES trial to collect valuable long-term data.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a long-term follow-up trial following an open-label, non-randomized trial in highly sensitized adult kidney transplant patients with positive crossmatch (XM) against an available deceased donor. The rational for the main trial, 20-HMedIdeS-19 (PAES), being non-randomized is that no other effective or approved desensitization protocol exists in deceased-donor kidney transplantation that would provide a suitable control. A non-comparative concurrent reference cohort from participating sites was included to address differences in-site practice and experience.
| Arm | Type | Receives |
|---|---|---|
| Imlifidase | Experimental | Drug: Imlifidase administered in the 20-HMedIdeS-19 (PAES) studyImlifidase administered in the 20-HMedIdeS-19 (PAES) study |
| Non-Comparative Concurrent Reference Cohort | Experimental | Other: Best available treatment administered in the 20-HMedIdeS-19 (PAES) studyBest available treatment administered in the 20-HMedIdeS-19 (PAES) study |
Who may qualify
- Ages
- 19 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent obtained before any trial-related procedures
- Willingness and ability to comply with the protocol
- Previously transplanted in the clinical trial 20-HmedIdeS-19 (PAES)
Key exclusion criteria (1 listed)
- Inability by the judgment of the investigator to participate in the trial for other reasons
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 |
|---|---|---|
| Imlifidase administered in the 20-HMedIdeS-19 (PAES) studyAlso: IdeS, HMED-IdeS, IdefirixImlifidase 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 |
| Best available treatment administered in the 20-HMedIdeS-19 (PAES) studyNormal transplantation routine Transplantation and pre- and post-transplantation therapies in accordance with the clinic's normal transplantation routine. | Other | Non-Comparative Concurrent Reference Cohort |
Primary outcome
Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation (imlifidase cohort only)
Time frame: 5-years after transplantation
Graft failure is defined as permanent return to dialysis for at least 6 weeks, re-transplantation, or nephrectomy. Patients not undergoing transplantation will be censored at time zero (i.e. at entry into the PAES trial). Transplanted patients not having an event (graft failure or death) will be censored at the last known date being alive and having a functioning graft. The 5-year graft failure-free survival rates will be estimated using the Kaplan-Meier estimator. Time from enrolment to the first of death or graft failure will be used as time variable.
16 secondary outcomes
Graft failure-free survival (%) up to 5 years after transplantation (non-comparative concurrent reference cohort only)
Time frame: 5-years after transplantation
Graft failure-free survival (%) up to 2 and 3 years after transplantation
Time frame: 2 and 3-years after transplantation
Renal function as evaluated by estimated Glomerular Filtration Rate (eGFR) and serum/plasma creatinine levels
Time frame: 2, 3, and 5-years after transplantation
Patient survival (%) after transplantation
Time frame: 2, 3, and 5-years after transplantation
Graft survival (%) after transplantation
Time frame: 2, 3, and 5-years after transplantation
Human Leukocyte Antigen (HLA)/Donor Specific Antibodies (DSA) levels (imlifidase cohort only)
Time frame: 2, 3, and 5-years after transplantation
Anti-drug antibody (ADA) levels (imlifidase cohort only)
Time frame: 2, 3, and 5-years after transplantation
Proportion of patients (%) with biopsy- and serology (DSA)-confirmed Antibody Mediated Rejections (AMRs)
Time frame: 2, 3, and 5-years after transplantation
Proportion of patients (%) with biopsy confirmed Cell-Mediated Rejections (CMRs)
Time frame: 2, 3, and 5-years after transplantation
Treatment of graft rejections
Time frame: 2, 3, and 5-years after transplantation
Treatment of graft rejection
Time frame: 2, 3, and 5-years after transplantation
Treatment of graft rejection
Time frame: 2, 3, and 5-years after transplantation
Adverse events (AEs)/serious adverse events (SAEs) suspected to be related to imlifidase treatment (imlifidase cohort only)
Time frame: 2, 3, and 5-years after transplantation
Use of immunosuppressive medication
Time frame: 2, 3, and 5-years after transplantation
Comorbidities
Time frame: 2, 3, and 5-years after transplantation
Change in patient reported life participation
Time frame: 2, 3, and 5-years after transplantation
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 23 Jun 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
14 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Imlifidase administered in the 20-HMedIdeS-19 (PAES) study and Best available treatment administered in the 20-HMedIdeS-19 (PAES) study in people with Long Term Efficacy and Safety, run by Hansa Biopharma AB at 14 sites in 7 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, France, Italy, Netherlands, Sweden and 2 more countries. 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?
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?
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?
Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation (imlifidase cohort only) (time frame: 5-years after transplantation). 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 23 Jun 2026.