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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000022-66 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imlifidase | Experimental | Subjects randomized to imlifidase treatment received one intravenous dose of imlifidase, 0.25 mg/kg, administered over 15 minutes. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imlifidase | Drug | Imlifidase is an immunoglobulin G (IgG) degrading enzyme of Streptococcus pyrogenes that cleaves all 4 human subclasses of IgG with strict specificity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Start of treatment until 5 days following start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Screening until Day 180 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Operations | Hansa Biopharma AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Brigham and Women Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39023092 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Imlifidase | Participants randomized to imlifidase |
| FG001 | Plasma Exchange | Participants randomized to plasma exchange |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2021 | Dec 13, 2023 |
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|
| Plasma Exchange | Other | 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. |
|
| 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. | Screening until Day 180 |
| Urine Albumine/Creatinine Ratio | The albumine/creatinine ratio in urine is a measure of kidney function. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | Screening until Day 6 |
| Pharmacokinetic (PK) Profile of Imlifidase: Cmax | Cmax = Maximum observed plasma concentration of imlifidase following dosing | 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 | 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). | 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) | 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. | 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 | 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. | Screening until Day 180 |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| New York University Grossman School of Medicine | New York | New York | 10016 | United States |
| The Royal Melbourne Hospital | Melbourne | Victoria | 3050 | Australia |
| Royal Adelaide Hospital | Adelaide | 5000 | Australia |
| Royal Prince Alfred Hospital | Sydney | Australia |
| Universitätsklinik für Innere Medizin III, Klinische Abteilung für Nephrologie MUW | Vienna | 1090 | Austria |
| Hôpital Pellegrin | Bordeaux | 33076 | France |
| CHU Grenoble Alpes - Néphrologie, dialyse et transplantation | Grenoble | 38043 | France |
| Hôpital Saint-Louis. Service de Néphrologie et Transplantation | Paris | 75475 | France |
| Hôpital Necker - Service de Néphrologie - Transplantation | Paris | 75743 | France |
| Charité-Universitätsmedizin. Dept. of Nephrology and Medical Intensive Care | Berlin | 13353 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Imlifidase | Participants randomized to imlifidase |
| BG001 | Plasma Exchange | Participants randomized to plasma exchange |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants with MFI values less than 1000 were excluded from the analysis | Posted | Mean | Standard Deviation | percentage of maximum DSA reduction | Start of treatment until 5 days following start of treatment |
|
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| ||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | percentage of DSA reduction | Screening until Day 180 |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Some patients had missing values at sporadic occasions. | Posted | Mean | Standard Deviation | mL/min/1.73m2 | Screening until Day 180 |
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| Secondary | Urine Albumine/Creatinine Ratio | The albumine/creatinine ratio in urine is a measure of kidney function. | Some patients had missing data at different occasions during the study. | Posted | Mean | Standard Deviation | mg/g | Pre-dose until Day 180 |
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| Secondary | Number of Patients With Graft Loss Within 180 Days of Treatment | Information on patients who experienced graft loss was collected throughout the study. | Posted | Count of Participants | Participants | Screening until Day 180 |
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| |||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | Day 180 |
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| |||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | Screening, Day 29 and Day 180 |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | Screening, Day 29, and Day 180 |
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| Secondary | 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. | In total 4 patients from the imlifidase arm were treated with PE. Of these 3 patients received PE after start of IVIg. All 10 patients from the PE arm were treated with PE. Of these 1 patient received PE after start of IVIg. One (1) patient from the PE arm also received IA after start of IVIg. | Posted | Number | Sessions | Day 1 to Day 180 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | mg/mL | Pre-dose until Day 6 |
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| Secondary | 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. | IVIg was administered on Day 4 (before 96 h measurement) to patients treated with imlifidase. Hence measurement of intact IgG was not performed for this group from 96 hours onwards. Measurement was stopped for PE patients when IVIg was administered. | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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. | Data was missing for a number of patients. | Posted | Mean | Standard Deviation | MFI counts | Screening until Day 6 |
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| Secondary | Pharmacokinetic (PK) Profile of Imlifidase: Cmax | Cmax = Maximum observed plasma concentration of imlifidase following dosing | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | 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 |
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| Secondary | PK Profile of Imlifidase: Tmax | Tmax = Time point for maximum observed plasma concentration of imlifidase following dosing | Posted | Median | Full Range | h | 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 |
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| Secondary | 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). | The data presents only patients who's time-concentration profile could be fitted to a 2-compartment model | Posted | Median | Full Range | h | 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 |
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| Secondary | PK Profile of Imlifidase: AUC | Area under the imlifidase plasma concentration vs time curve (AUC) | Posted | Geometric Mean | Geometric Coefficient of Variation | h×µg/mL | 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 |
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| Secondary | PK Profile of Imlifidase: CL | Clearance (CL) of imlifidase means the volume of blood cleared of imlifidase per unit of time. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/h/kg | 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 |
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| Secondary | 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 | Posted | Geometric Mean | Geometric Coefficient of Variation | L/kg | 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 |
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| Secondary | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/L | Screening until Day 180 |
|
|
Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the participant signed the informed consent form (ICF) until end of study, including the follow-up period). AEs occurring after the start of trial treatment and within the time of residual drug effect which is 28 days after start of trial treatment are classified as treatment emergent AEs (TEAEs).
AEs were obtained if spontaneously reported, if reported in response to an open question from the study personnel or if revealed by observation.
The reported data consists of TEAEs regardless of whether they are considered treatment-related or non-treatment-related.
The reported data on mortality includes the 6 months follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Imlifidase | Participants randomized to imlifidase | 1 | 19 | 3 | 19 | 17 | 19 |
| EG001 | Plasma Exchange | Participants randomized to plasma exchange | 0 | 10 | 3 | 10 | 10 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Nephrogenic anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Muscle haemorrhage | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
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| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (21.1) | Systematic Assessment |
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| Ear discomfort | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (21.1) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Catheter site haemorrhage | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Catheter site pain | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Gait disturbance | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Malaise | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (21.1) | Systematic Assessment |
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| Hepatocellular injury | Hepatobiliary disorders | MedDRA (21.1) | Systematic Assessment |
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| Transplant rejection | Immune system disorders | MedDRA (21.1) | Systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (21.1) | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
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| Renal lymphocele | Injury, poisoning and procedural complications | MedDRA (21.1) | Systematic Assessment |
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| Acid base balance abnormal | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Antibody test positive | Investigations | MedDRA (21.1) | Systematic Assessment |
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| BK polyomavirus test positive | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Blood glucose fluctuation | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA (21.1) | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Immunosuppressant drug level increased | Investigations | MedDRA (21.1) | Systematic Assessment |
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| Calcium deficiency | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
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| Folate deficiency | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Feeling of despair | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (21.1) | Systematic Assessment |
|
At the end of the study, one or more manuscripts for joint publication may be prepared in collaboration between the investigator(s) offered authorship and Hansa Biopharma.
Any confidential information relating to imlifidase or the study, including any data and results from the study will be the exclusive property of Hansa Biopharma AB. The investigators and any other persons involved in the trial will protect the confidentiality of the proprietary information belonging to Hansa Biopharma AB.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Research and Development | Hansa Biopharma AB | +4646165670 | info@hansabiopharma.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 27, 2022 | Dec 13, 2023 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| C442815 | Mac-1-like protein, Streptococcus |
| D010951 | Plasma Exchange |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
| D001781 | Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| France |
|
| Australia |
|
| Germany |
|
|
|
|
|
|
|
|
|
|
|
|
| Denominators |
|---|
| Categories |
|---|
|
| Categories |
|---|
|
|
| Categories |
|---|
|
| Denominators |
|---|
| Categories |
|---|
|
| Title | Denominators | Categories |
|---|
| Vss |
| |||||
| Vz |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Pre-dose |
| |||||
| 24 hours |
| |||||
| Day 8 |
| |||||
| Day 11 |
| |||||
| Day 15 |
| |||||
| Day 22 |
| |||||
| Day 29 |
| |||||
| Day 64 |
| |||||
| Day 90 |
| |||||
| Day 180 |
|
| Active AMR + CMR |
|
| Chronic Active AMR + Borderline CMR |
|
| Chronic Active AMR + CMR |
|
| Chronic Active AMR |
|
| Borderline CMR |
|
| CMR |
|
| No rejection |
|
| Missing data |
|
| Active AMR + CMR |
|
| Chronic Active AMR + Borderline CMR |
|
| Chronic Active AMR + CMR |
|
| Chronic Active AMR |
|
| Borderline CMR |
|
| CMR |
|
| No rejection |
|
| Missing data |
|
| Mix of intact IgG and scIgG |
|
| Only scIgG |
|
| Mix of scIgG and F(ab')2 |
|
| Only F(ab')2 |
|
| No intact IgG, scIgG, or F(ab')2 |
|
| Mix of intact IgG and scIgG |
|
| Only scIgG |
|
| Mix of scIgG and F(ab')2 |
|
| Only F(ab')2 |
|
| No intact IgG, scIgG, or F(ab')2 |
|
| Mix of intact IgG and scIgG |
|
| Only scIgG |
|
| Mix of scIgG and F(ab')2 |
|
| Only F(ab')2 |
|
| No intact IgG, scIgG, or F(ab')2 |
|
| Mix of intact IgG and scIgG |
|
| Only scIgG |
|
| Mix of scIgG and F(ab')2 |
|
| Only F(ab')2 |
|
| No intact IgG, scIgG, or F(ab')2 |
|
| Mix of intact IgG and scIgG |
|
| Only scIgG |
|
| Mix of scIgG and F(ab')2 |
|
| Only F(ab')2 |
|
| No intact IgG, scIgG, or F(ab')2 |
|
| Mix of intact IgG and scIgG |
|
| Only scIgG |
|
| Mix of scIgG and F(ab')2 |
|
| Only F(ab')2 |
|
| No intact IgG, scIgG, or F(ab')2 |
|
| Mix of intact IgG and scIgG |
|
| Only scIgG |
|
| Mix of scIgG and F(ab')2 |
|
| Only F(ab')2 |
|
| No intact IgG, scIgG, or F(ab')2 |
|
| Mix of intact IgG and scIgG |
|
| Only scIgG |
|
| Mix of scIgG and F(ab')2 |
|
| Only F(ab')2 |
|
| No intact IgG, scIgG, or F(ab')2 |
|
| Mix of intact IgG and scIgG |
|
| Only scIgG |
|
| Mix of scIgG and F(ab')2 |
|
| Only F(ab')2 |
|
| No intact IgG, scIgG, or F(ab')2 |
|
| Mix of intact IgG and scIgG |
|
| Only scIgG |
|
| Mix of scIgG and F(ab')2 |
|
| Only F(ab')2 |
|
| No intact IgG, scIgG, or F(ab')2 |
|