Kidney Transplant RejectionPhase 2NCT03897205
An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients
A Phase 2 study testing Imlifidase and Plasma Exchange in people with Kidney Transplant Rejection, run by Hansa Biopharma AB at 14 sites in 5 countries.
Trial summary
The purpose of this study was to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have had an active or chronic active antibody mediated rejection (AMR) after being kidney transplanted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Imlifidase and Plasma Exchange
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 30 Apr 2019to 16 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent obtained before any study-related procedures
- Willingness and ability to comply with the protocol
- Male and/or female donor kidney recipients age ≥18 years at the time of screening
- Presence of DSA(s)
- Meet the Banff 2017 criteria for active or chronic active AMR
- At least 25% rise in serum creatinine compared to last individual value taken prior to the AMR. Patients with delayed graft function and AMR within 10 days after transplant (confirmed by kidney biopsy) can be included regardless of serum creatinine level
- Women of child-bearing potential willing or able to use at least one highly effective contraceptive method throughout the study. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly
- Men willing to use double-barrier contraception from the first day of treatment until at least 2 months after the dose of imlifidase, if not abstinent
Who cannot join
- Previous treatment with imlifidase
- Previous high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion
- Lactating or pregnant females
- Significantly abnormal general serum screening lab results judged inappropriate for inclusion in the study by the investigator
- Intake of other investigational drugs within 5 half-lives (or similar) of the product prior to inclusion
- Clinically relevant active infection(s) as judged by the investigator
Show all 12Show fewer
- Any condition that in the opinion of the investigator could increase the subject's risk by participating in the study such as severe immune deficiency and severe cardiac insufficiency [New York Heart Association (NYHA) Class IV] or severe uncontrolled heart disease
- Known allergy/sensitivity to imlifidase, IVIg and/or rituximab and the respective excipients
- Patient unable to tolerate treatment with plasmapheresis or immunoadsorption, as judged by the investigator
- Unsuitable to participate in the study for any other reason as judged by the investigator
- Positive polymerase chain reaction (PCR) test for severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection
- Current diagnosis or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
United States4 sites
Brigham and Women Hospital
Boston, Massachusetts, 02115
Cedars-Sinai Medical Center
Los Angeles, California, 90048
New York University Grossman School of Medicine
New York, New York, 10016
Mayo Clinic
Rochester, Minnesota, 55905
France4 sites
Hôpital Pellegrin
Bordeaux, 33076
CHU Grenoble Alpes - Néphrologie, dialyse et transplantation
Grenoble, 38043
Hôpital Saint-Louis. Service de Néphrologie et Transplantation
Paris, 75475
Hôpital Necker - Service de Néphrologie - Transplantation
Paris, 75743
Australia3 sites
Royal Adelaide Hospital
Adelaide, 5000
The Royal Melbourne Hospital
Melbourne, Victoria, 3050
Royal Prince Alfred Hospital
Sydney
Germany2 sites
Charité-Universitätsmedizin. Dept. of Nephrology and Medical Intensive Care
Berlin, 13353
Medizinische Hochschule Hannover
Hanover, 30625
Austria1 site
Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie MUW
Vienna, 1090
About this study
Official title: A Randomized, Open-Label, Multi-Centre, Active Control, Efficacy and Safety Study of Imlifidase in Eliminating Donor Specific Anti-HLA Antibodies in the Treatment of Active Antibody-Mediated Rejection in Kidney Transplant Patients
The purpose of this study was to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have had an active or chronic active antibody mediated rejection (AMR) after being kidney transplanted. The purpose was also to investigate and compare safety for these two treatments.
Read the detailed description
Antibodies to human leukocyte antigens (HLAs) have a strong correlation with allograft injury and loss. Treatment with imlifidase, PE and immunoabsorption (IA) all aim to reduce antibody levels.
This study compared the reduction in DSA levels after treatment with imlifidase and PE in patients diagnosed with active or chronic active AMR (according to Banff 2017 or Banff 2019 criteria) having at least a 25% rise in serum creatinine compared with last measurement prior to the AMR. (Patients with delayed graft function and AMR within 10 days after kidney transplantation could be included regardless of serum creatinine level.) Eligible patients were randomized to either 1 dose of imlifidase (0.25 mg/kg) or 5-10 sessions of PEs (IA could replace PE at the discretion of the investigator).
All patients received pulse methylprednisolone Day 1 to Day 3, followed by a tapering schedule with prednisolone/prednisone. Patients randomised to imlifidase received their first dose of methylprednisolone before imlifidase was administered. The patients did also receive high dose intravenous immunoglobulin (IVIg) 3 days after imlifidase treatment or directly after the last PE. In addition a single dose of rituximab was given 5 days after completed IVIg infusion.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Imlifidase, Plasma Exchange
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImlifidaseDrug
Also called HMED-IdeS, IdeS, IgG endopeptidase
Imlifidase is an immunoglobulin G (IgG) degrading enzyme of Streptococcus pyrogenes that cleaves all 4 human subclasses of IgG with strict specificity.
Plasma ExchangeOther
The subject's plasma is removed and discarded and the subject receives replacement donor plasma, albumin, or a combination of albumin and saline. IA may be used instead of PE to the discretion of the investigator. IA is achieved by passing a subject's plasma over columns that bind immunoglobulins and then the plasma is passed back to the subject.
| Study group | Role | What they receive |
|---|---|---|
| Imlifidase | Experimental | Subjects randomized to imlifidase treatment received one intravenous dose of imlifidase, 0.25 mg/kg, administered over 15 minutes. Receives: Drug: Imlifidase |
| Plasma Exchange | Active comparator | Subjects randomized to plasma exchange (PE) treatment received 5-10 sessions of PE, as judged by the investigator. Immunoadsorption (IA) could replace PE, at the discretion of the investigator. Receives: Other: Plasma Exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Reduction in Donor Specific Antibodies (DSA) Level During the 5 Days Following the Start of Treatment
Maximum reduction (%) in the sum of DSA at any time point during the 5 days following the start of treatment.
Only DSA with ≥1000 mean fluorescence intensity (MFI) at pre-treatment were included in the calculations.
Clarification: The higher the maximum reduction percentage the lower the remaining DSA level.
Measured: Start of treatment until 5 days following start of treatment
Secondary outcomes (18)
Reduction in DSA Levels After Treatment
DSA levels were assessed at all visits throughout the study. The results are presented as reduction (%) from baseline. Clarification: The higher the reduction percentage the lower the remaining DSA level. Please observe that a negative reduction value represents an increase in DSA level from baseline.
Measured: Screening until Day 180
Estimated Glomerular Filtration Rate (eGFR) Levels
eGFR as calculated from p-creatinine is a measure of kidney function. eGFR was assessed at all visits throughout the study.
Measured: Screening until Day 180
Urine Albumine/Creatinine Ratio
The albumine/creatinine ratio in urine is a measure of kidney function.
Measured: Pre-dose until Day 180
Number of Patients With Graft Loss Within 180 Days of Treatment
Information on patients who experienced graft loss was collected throughout the study.
Measured: Screening until Day 180
Number of Patients With Signs or no Signs of Transplant Glomerulopathy at Day 180
Biopsies collected 180 days after treatment were analysed for signs of glomerulopathy.
Measured: Day 180
Number of Patients With Different Types of Kidney Histopathology Throughout the Trial
Kidney biopsies were assessed according to the Banff (2017) criteria at screening (baseline), Day 29, and Day 180.
Abbreviations: AMR=Antibody mediated rejection, CMR=cell-mediated rejection
Measured: Screening, Day 29 and Day 180
Number of Patients With Resolved AMR as Assessed by Messenger Ribonucleic Acid (mRNA) Levels
Kidney biopsies were taken at screening, Day 29, and Day 180. Changes from baseline in mRNA levels were assessed as evidence of resolved AMR.
Measured: Screening, Day 29, and Day 180
Number of Administered Plasma Exchange (PE) and Immunoadsorption (IA) Sessions
Total number of administered PE and IA sessions to each treatment group are presented during the complete trial (Day 1 to Day 180) and for the time period: start of IVIg administration to Day 180.
Measured: Day 1 to Day 180
Total Serum Immunoglobulin G (IgG) Levels Until Administration of Intravenous Immunoglobulin (IVIg)
Total serum IgG levels over time following treatment until administration of IVIg.
Please observe, IVIg was initiated on Day 4 (before 96 h measurement) for the imlifidase group.
Measured: Pre-dose until Day 6
Number of Patients With Intact IgG, Single-cleaved IgG (scIgG), F(ab')2 Fragments Following Treatment Until Administration of IVIg
Presence of IgG, scIgG, and F(ab')2 was analysed using sodium dodecyl-sulphate polyacrylamide gel electrophoresis (SDS-PAGE)/western blot.
Of note, IVIg was administered on Day 4 (before 96 h measurement) to patients treated with imlifidase. Hence no analyses beyond this timepoint were performed for this group.
Measured: Start of treatment (Day 1) up to administration of IVIg on Day 4 (imlifidase group) and until administration of IVIg within Day 15 (PE group)
DSA Functionality Determined by C1q Analysis Pre- and Post-treatment
An MFI value above 6000 is indicative of complement fixation. Analysis of DSA functionality assessed as mean MFI levels was done before and after treatment.
Measured: Screening until Day 6
Pharmacokinetic (PK) Profile of Imlifidase: Cmax
Cmax = Maximum observed plasma concentration of imlifidase following dosing
Measured: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
PK Profile of Imlifidase: Tmax
Tmax = Time point for maximum observed plasma concentration of imlifidase following dosing
Measured: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
PK Profile of Imlifidase: t1/2
t1/2 = terminal half-life of imlifidase (refers to the time required for plasma concentration of a drug to decrease by 50%) Different mathematical models are available to describe how drugs are adsorbed, distributed, metabolised, and eliminated from the body. The time-concentration curve of imlifidase could be fitted to the so called 2-compartment model. This model divide the body into a central and an peripheral compartment. The central compartment consist of the plasma and tissues where the distribution is fast and the peripheral consists of tissues where the distribution of the drug is slower. As a result the elimination of imlifidase consists of an initial phase with a short half life (alpha-t1/2) and an elimination phase with a longer half-life (beta-t1/2).
Measured: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
PK Profile of Imlifidase: AUC
Area under the imlifidase plasma concentration vs time curve (AUC)
Measured: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
PK Profile of Imlifidase: CL
Clearance (CL) of imlifidase means the volume of blood cleared of imlifidase per unit of time.
Measured: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
PK Profile of Imlifidase: Volume of Distribution (V)
Vss = volume of distribution associated with steady state VZ = volume of distribution associated with the elimination phase
Measured: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
Concentration of Anti-drug Antibodies (ADAs)
Samples were collected and analysed for presence of anti-imlifidase IgG throughout the study.
Imlifidase is an IgG-degrading enzyme of Streptococcus pyogenes. Patients who have been exposed to Streptococcus prior to participating in this trial tested positive for ADA also before exposure to imlifidase.
Measured: Screening until Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start30 Apr 2019
- Primary completion28 May 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Transplant RejectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT03897205
- Sponsor's protocol ID
- 16-HMedIdeS-12
- Other IDs
- 2018-000022-66, 2018
- Status last verified
- Jan 2024
- First submitted
- 27 Mar 2019
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halleck F, Bohmig GA, Couzi L, Rostaing L, Einecke G, Lefaucheur C, Legendre C, Montgomery R, Hughes P, Chandraker A, Wyburn K, Halloran P, Maldonado AQ, Sjoholm K, Runstrom A, Lefevre P, Tollemar J, Jordan S. A Randomized Trial Comparing Imlifidase to Plasmapheresis in Kidney Transplant Recipients With Antibody-Mediated Rejection. Clin Transplant. 2024 Jul;38(7):e15383. doi: 10.1111/ctr.15383.
PubMed 39023092
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multi-Centre, Active Control, Efficacy and Safety Study of Imlifidase in Eliminating Donor Specific Anti-HLA Antibodies in the Treatment of Active Antibody-Mediated Rejection in Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT03897205
- Acronym / sponsor ID
- 16-HMedIdeS-12
- Conditions
- Kidney Transplant Rejection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hansa Biopharma ABIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 28 May 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have had an active or chronic active antibody mediated rejection (AMR) after being kidney transplanted. The purpose was also to investigate and compare safety for these two treatments.
Detailed description
Antibodies to human leukocyte antigens (HLAs) have a strong correlation with allograft injury and loss. Treatment with imlifidase, PE and immunoabsorption (IA) all aim to reduce antibody levels.
This study compared the reduction in DSA levels after treatment with imlifidase and PE in patients diagnosed with active or chronic active AMR (according to Banff 2017 or Banff 2019 criteria) having at least a 25% rise in serum creatinine compared with last measurement prior to the AMR. (Patients with delayed graft function and AMR within 10 days after kidney transplantation could be included regardless of serum creatinine level.) Eligible patients were randomized to either 1 dose of imlifidase (0.25 mg/kg) or 5-10 sessions of PEs (IA could replace PE at the discretion of the investigator).
All patients received pulse methylprednisolone Day 1 to Day 3, followed by a tapering schedule with prednisolone/prednisone. Patients randomised to imlifidase received their first dose of methylprednisolone before imlifidase was administered. The patients did also receive high dose intravenous immunoglobulin (IVIg) 3 days after imlifidase treatment or directly after the last PE. In addition a single dose of rituximab was given 5 days after completed IVIg infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imlifidase | Experimental | Drug: ImlifidaseSubjects randomized to imlifidase treatment received one intravenous dose of imlifidase, 0.25 mg/kg, administered over 15 minutes. |
| Plasma Exchange | Active comparator | Other: Plasma ExchangeSubjects randomized to plasma exchange (PE) treatment received 5-10 sessions of PE, as judged by the investigator. Immunoadsorption (IA) could replace PE, at the discretion of the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed Informed Consent obtained before any study-related procedures
- Willingness and ability to comply with the protocol
- Male and/or female donor kidney recipients age ≥18 years at the time of screening
- Presence of DSA(s)
- Meet the Banff 2017 criteria for active or chronic active AMR
Key exclusion criteria (12 listed)
- Previous treatment with imlifidase
- Previous high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion
- Lactating or pregnant females
- Significantly abnormal general serum screening lab results judged inappropriate for inclusion in the study by the investigator
- Intake of other investigational drugs within 5 half-lives (or similar) of the product prior to inclusion
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: HMED-IdeS, IdeS, IgG endopeptidaseImlifidase is an immunoglobulin G (IgG) degrading enzyme of Streptococcus pyrogenes that cleaves all 4 human subclasses of IgG with strict specificity. | Drug | Imlifidase |
| Plasma ExchangeThe subject's plasma is removed and discarded and the subject receives replacement donor plasma, albumin, or a combination of albumin and saline. IA may be used instead of PE to the discretion of the investigator. IA is achieved by passing a subject's plasma over columns that bind immunoglobulins and then the plasma is passed back to the subject. | Other | Plasma Exchange |
Primary outcome
Maximum Reduction in Donor Specific Antibodies (DSA) Level During the 5 Days Following the Start of Treatment
Time frame: Start of treatment until 5 days following start of treatment
Maximum reduction (%) in the sum of DSA at any time point during the 5 days following the start of treatment. Only DSA with ≥1000 mean fluorescence intensity (MFI) at pre-treatment were included in the calculations. Clarification: The higher the maximum reduction percentage the lower the remaining DSA level.
18 secondary outcomes
Reduction in DSA Levels After Treatment
Time frame: Screening until Day 180
Estimated Glomerular Filtration Rate (eGFR) Levels
Time frame: Screening until Day 180
Urine Albumine/Creatinine Ratio
Time frame: Pre-dose until Day 180
Number of Patients With Graft Loss Within 180 Days of Treatment
Time frame: Screening until Day 180
Number of Patients With Signs or no Signs of Transplant Glomerulopathy at Day 180
Time frame: Day 180
Number of Patients With Different Types of Kidney Histopathology Throughout the Trial
Time frame: Screening, Day 29 and Day 180
Number of Patients With Resolved AMR as Assessed by Messenger Ribonucleic Acid (mRNA) Levels
Time frame: Screening, Day 29, and Day 180
Number of Administered Plasma Exchange (PE) and Immunoadsorption (IA) Sessions
Time frame: Day 1 to Day 180
Total Serum Immunoglobulin G (IgG) Levels Until Administration of Intravenous Immunoglobulin (IVIg)
Time frame: Pre-dose until Day 6
Number of Patients With Intact IgG, Single-cleaved IgG (scIgG), F(ab')2 Fragments Following Treatment Until Administration of IVIg
Time frame: Start of treatment (Day 1) up to administration of IVIg on Day 4 (imlifidase group) and until administration of IVIg within Day 15 (PE group)
DSA Functionality Determined by C1q Analysis Pre- and Post-treatment
Time frame: Screening until Day 6
Pharmacokinetic (PK) Profile of Imlifidase: Cmax
Time frame: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
PK Profile of Imlifidase: Tmax
Time frame: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
PK Profile of Imlifidase: t1/2
Time frame: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
PK Profile of Imlifidase: AUC
Time frame: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
PK Profile of Imlifidase: CL
Time frame: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
PK Profile of Imlifidase: Volume of Distribution (V)
Time frame: Pre-dose, 30 min, 1 h, 2 h, 6 h, 24 h, 48 h, 72 h, 96 h, Day 6, Day 8, Day 1, and Day 15
Concentration of Anti-drug Antibodies (ADAs)
Time frame: Screening until Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39023092Halleck F, Bohmig GA, Couzi L, Rostaing L, Einecke G, Lefaucheur C, Legendre C, Montgomery R, Hughes P, Chandraker A, Wyburn K, Halloran P, Maldonado AQ, Sjoholm K, Runstrom A, Lefevre P, Tollemar J, Jordan S. A Randomized Trial Comparing Imlifidase to Plasmapheresis in Kidney Transplant Recipients With Antibody-Mediated Rejection. Clin Transplant. 2024 Jul;38(7):e15383. doi: 10.1111/ctr.15383.
- 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 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imlifidase and Plasma Exchange in people with Kidney Transplant Rejection, run by Hansa Biopharma AB at 14 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 12 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 28 Feb 2024. 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 United States, France, Australia, Germany, Austria. 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?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Reduction in Donor Specific Antibodies (DSA) Level During the 5 Days Following the Start of Treatment (time frame: Start of treatment until 5 days following start of treatment). 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 NCT03897205, 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 28 Feb 2024.