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| Name | Class |
|---|---|
| Hansa Biopharma AB | INDUSTRY |
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This study will evaluate the safety and tolerability of IdeS in patients with severe anti-glomerular basement membrane (anti-GBM) disease receiving standard of care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide combined with plasma exchange (PLEX).
This is an Open-Label Phase 2 Study to Evaluate the Efficacy and Safety of IdeS in anti-GBM disease (Goodpasture's disease, i.e. GP) with Adverse Renal Prognosis. The primary efficacy objective is to evaluate the efficacy of an IdeS based regimen to salvage independent renal function measured as no need for dialysis at 6 months after IdeS treatment. The primary safety objective of this study is to evaluate the safety and tolerability of IdeS in patients with severe anti-GBM disease on background of standard care consisting of pulse-methylprednisolone, oral prednisolone and intravenous cyclophosphamide (CYC) combined with plasma exchange (PLEX). The patients will be followed during 6 months according to the study visit plan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imlifidase | Experimental | Imlifidase 0.25 mg/kg body weight intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imlifidase | Biological | One dose of 0.25 mg/kg body weight imlifidase on study day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Independent Renal Function at 6 Months | Number of patients without need for dialysis at 6 months. A patient with independent renal function is defined as a patient without need for dialysis. | 6 months after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Independent Renal Function at 3 Months | Number of patients without need for dialysis at 3 months. A patient with independent renal function is defined as a patient without need for dialysis. | 3 months after dosing |
| Renal Function at 3 and 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mårten Segelmark, MD PhD Prof | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine IV (Nephrology and Hypertension) | Innsbruck | 6020 | Austria | |||
| Department of Department of nephrology, First Faculty of Medicine and General Teaching Hospital and Charles University in Prague, Czech Republic, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20616173 | Background | Berden AE, Ferrario F, Hagen EC, Jayne DR, Jennette JC, Joh K, Neumann I, Noel LH, Pusey CD, Waldherr R, Bruijn JA, Bajema IM. Histopathologic classification of ANCA-associated glomerulonephritis. J Am Soc Nephrol. 2010 Oct;21(10):1628-36. doi: 10.1681/ASN.2010050477. Epub 2010 Jul 8. | |
| 29162595 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment HMed-IdeS | A single dose of IdeS (imlifidase) 0.25 mg/kg body weight (BW) intravenous infusion on study Day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Imlifidase | IdeS intravenous infusion 0.25 mg/kg body weight (BW) intravenous infusion HMed-IdeS: One dose of 0.25 mg/kg BW HMed-IdeS on study day 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Number of Patients With Independent Renal Function at 6 Months | Number of patients without need for dialysis at 6 months. A patient with independent renal function is defined as a patient without need for dialysis. | Posted | Count of Participants | Participants | 6 months after dosing |
|
Adverse events (AEs) were collected for 6 months (i.e., from the timepoint the patient signed the informed consent form (ICF) until end of study. A treatment emergent adverse event (TEAE) is defined as any AE occurring after imlifidase administration and within the time of the residual drug effect period (i.e. 28 days after admin).
Data on AEs were obtained if spontaneously reported, if reported in response to an open question, or if revealed by observation.
All Serious Adverse Events (SAEs) were post-TEAEs and those are listed in the "SAE" table.
"Other (Not Including Serious) Adverse Events" presents all reported AEs in the study (47 TEAEs and 35 post-TEAEs).
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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 | Safety Analysis Set | All patients who have received imlifidase. | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Mårten Segelmark | Linköping University | +46 70 287 19 44 | marten.segelmark@liu.se |
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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 | Feb 13, 2018 | Aug 19, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2020 | Aug 19, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C538458 | Rapidly progressive glomerulonephritis with pulmonary hemorrhage |
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| ID | Term |
|---|---|
| C442815 | Mac-1-like protein, Streptococcus |
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Open-Label, Single Arm study
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Estimated glomerular filtration rate (eGFR) is a measure of kidney function. eGFR was calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. eGFR for a kidney with normal function is above 90 mL/min/1.73m^2. Reduced kidney function is characterised by a decreased eGFR value. |
| 3 and 6 months after imlifidase dosing |
| Number of Patients With Renal Function Over Time Stratified by Ranges of eGFR | eGFR is a measure of kidney function. eGFR has been calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. eGFR for a kidney with normal function is above 90 mL/min/1.73m^2. Reduced kidney function is characterised by a decreased eGFR value. Number of patients per 4 different eGFR categories (0-15, 15-30, 30-60, ≥60 mL/min/1.73m^2) are presented. A shift towards a higher category during the study indicates improved renal function over time. | Pre-imlifidase, 1, 3 and 6 months after imlifidase dosing |
| Number of Patients With Anti-GBM Antibodies Above a Toxic Level Stratified by Number of Study Visits | Anti-GBM antibodies above a toxic level defined as >20 U/mL. The level of anti-GBM antibodies was measured centrally using the Phadia ELiA(TM) anti-GBM kit. The enzyme-linked immunoassay (ELiA) is a fluorescence enzyme immunoassay. | Predose up to 6 months after dosing |
| Number of Patients With Haematuria (Blood in Urine) | Haematuria was assessed using urine dipstick. The result was presented as: Negative/Trace/+1/+2/+3/+4. In the analysis results being +2 or above are considered as relevant. Haematuria was an inclusion criterion. All 15 patients had haematuria when included in the study. | At 6 months after dosing |
| Change in Proteinuria During the Study | Change in proteinuria measured as u-albumin/creatinine (g/mol) in morning void during the study . | Pre-imlifidase, 3 and 6 months after imlifidase dosing |
| Number of PLEXs Needed Over Time | Number of PLEXs needed before anti-GBM antibodies are below toxic levels. PLEX was initiated at the discretion of the investigator throughout the study. | Pre-screening and up to Day 93 after imlifidase dosing |
| Pharmacokinetics of Imlifidase (Cmax) | Maximum observed plasma concentration of IdeS following dosing (Cmax) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 |
| Pharmacokinetics of Imlifidase (AUC) | Area under the plasma concentration versus time curve (AUC) | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 |
| Pharmacokinetics of Imlifidase (t1/2) | Half-life during distribution phase (Alpha-t1/2) Half-life during elimination phase (Beta-t1/2) The results refers to harmonic mean. | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 |
| Pharmacokinetics of Imlifidase (CL) | Clearance (CL) is a measure of the ability of the body to clear imlifidase from plasma | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 |
| Pharmacokinetics of Imlifidase (Vz) | Vz = Volume of distribution during the elimination phase | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 |
| Pharmacodynamics (IgG Degradation Measured as Remaining Concentration of Intact and Single Cleaved IgG) | Imlifidase specifically cleaves all subclasses of human IgG rapidly and efficiently. The cleaving process involves two steps: (i) intact IgG to single cleaved IgG followed by (ii) single cleaved IgG to completely cleaved IgG (one F(ab')2- and one homodimeric Fc-fragment) The electroluminescence analysis method used measures the sum of intact and single cleaved IgG in serum. The efficacy of imlifidase is evaluated as remaining concentration of intact and single cleaved IgG in serum after treatment. | Pre-dose up to 6 months after imlifidase administration |
| Anti-imlifidase Antibodies (ADA) | Determination of anti-imlifidase antibody concentration | Up to 6 months after dosing |
| Renal Histology | Kidney biopsies were classified according to the histopathologic classification for antineutrophil cytoplasmic antibodies (ANCA)-associated glomerulonephritis developed by Berden et al. 2010. This classification has previously been applied in a study of 123 anti-GBM disease patients (von Daalen et al 2018). Histopathologic class:
Focal class is associated with favourable kidney outcome, whereas sclerotic carries a poor outcome. Crescentic/mixed class could have an intermediate outcome between focal and sclerotic. Immunofluorescence performed at the local hospitals was also used to assess linear IgG deposits which is a hallmark of anti-GBM antibody disease. | Before administration of imlifidase (0-33 days) and after administration of imlifidase (3-6 days) |
| Prague |
| 121 08 |
| Czechia |
| Department of Department of Nephrology, Rigshospitalet, Copenhagen | Copenhagen | 2100 | Denmark |
| PH USI UNTR, service du Pr Rondeau, Hôpital Tenon | Paris | Paris Cedex 20 | 75020 | France |
| Department of Nephrology, Hemodialysis, Apheresis, and Transplantation, CHUGA (centre hospitalier universitaire Grenoble-Alpes) | Grenoble | France |
| Centre Hospitalier Régional Universitaire de Lille, Nephrology Service | Lille | 59000 | France |
| Nephrology Service CHU Bichat | Paris | 75018 | France |
| Department of Nephrology and Organ Transplant, CHU Rangueil | Toulouse | 31059 | France |
| Karolinska University Hospital Huddinge | Stockholm | 141 86 | Sweden |
| Department of Nephrology, Uppsala University Hospital | Uppsala | 75185 | Sweden |
| van Daalen EE, Jennette JC, McAdoo SP, Pusey CD, Alba MA, Poulton CJ, Wolterbeek R, Nguyen TQ, Goldschmeding R, Alchi B, Griffiths M, de Zoysa JR, Vincent B, Bruijn JA, Bajema IM. Predicting Outcome in Patients with Anti-GBM Glomerulonephritis. Clin J Am Soc Nephrol. 2018 Jan 6;13(1):63-72. doi: 10.2215/CJN.04290417. Epub 2017 Nov 21. |
| 37385828 | Derived | Tyrberg L, Andersson F, Uhlin F, Hellmark T, Segelmark M. Using imlifidase to elucidate the characteristics and importance of anti-GBM antibodies produced after start of treatment. Nephrol Dial Transplant. 2023 Dec 20;39(1):45-54. doi: 10.1093/ndt/gfad132. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Dialysis status at baseline | Count of Participants | Participants |
|
| Time since anti-glomerular basement membrane (anti-GBM) diagnosis | Median | Full Range | days |
|
| Anti-GBM concentration | Median | Full Range | U/mL |
|
| Time since first renal symptom | Median | Full Range | days |
|
| Occurrence of pulmonary symptom | Count of Participants | Participants |
|
| Time since first pulmonary symptom | Median | Full Range | days |
|
| Double positive Anti-GBM and antineutrophil cytoplasmic antibodies (ANCA) | ANCA=anti-neutrophil cytoplasm antibody | Count of Participants | Participants |
|
All patients (i.e., both patients who were dialysis dependent and patients who were dialysis independent at baseline) |
|
|
| Secondary | Number of Patients With Independent Renal Function at 3 Months | Number of patients without need for dialysis at 3 months. A patient with independent renal function is defined as a patient without need for dialysis. | Posted | Count of Participants | Participants | 3 months after dosing |
|
|
|
| Secondary | Renal Function at 3 and 6 Months | Estimated glomerular filtration rate (eGFR) is a measure of kidney function. eGFR was calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. eGFR for a kidney with normal function is above 90 mL/min/1.73m^2. Reduced kidney function is characterised by a decreased eGFR value. | Only patients who were alive and dialysis independent at respective analysis time (3 and 6 months) were included in this analysis because assessment of eGFR is not considered meaningful for patients in dialysis. | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | 3 and 6 months after imlifidase dosing |
|
|
|
| Secondary | Number of Patients With Renal Function Over Time Stratified by Ranges of eGFR | eGFR is a measure of kidney function. eGFR has been calculated based on p-creatinine according to the modification of diet in renal disease (MDRD) equation. eGFR for a kidney with normal function is above 90 mL/min/1.73m^2. Reduced kidney function is characterised by a decreased eGFR value. Number of patients per 4 different eGFR categories (0-15, 15-30, 30-60, ≥60 mL/min/1.73m^2) are presented. A shift towards a higher category during the study indicates improved renal function over time. | Only patients who were alive and dialysis independent at each specific analysis time are included in this analysis because eGFR is not applicable for patients in dialysis. | Posted | Count of Participants | Participants | Pre-imlifidase, 1, 3 and 6 months after imlifidase dosing |
|
|
|
| Secondary | Number of Patients With Anti-GBM Antibodies Above a Toxic Level Stratified by Number of Study Visits | Anti-GBM antibodies above a toxic level defined as >20 U/mL. The level of anti-GBM antibodies was measured centrally using the Phadia ELiA(TM) anti-GBM kit. The enzyme-linked immunoassay (ELiA) is a fluorescence enzyme immunoassay. | Number of study visits with a toxic level are presented instead of number of patient days with an anti-GBM level >20 U/mL as was the original plan. | Posted | Number | participants | Predose up to 6 months after dosing |
|
|
|
| Secondary | Number of Patients With Haematuria (Blood in Urine) | Haematuria was assessed using urine dipstick. The result was presented as: Negative/Trace/+1/+2/+3/+4. In the analysis results being +2 or above are considered as relevant. Haematuria was an inclusion criterion. All 15 patients had haematuria when included in the study. | Data was missing for 5 of the 15 patients at 6 months. | Posted | Number | Patients with haematuria (+2 or above) | At 6 months after dosing |
|
|
|
| Secondary | Change in Proteinuria During the Study | Change in proteinuria measured as u-albumin/creatinine (g/mol) in morning void during the study . | Some patients had missing data at some visits | Posted | Mean | Standard Deviation | g/mol | Pre-imlifidase, 3 and 6 months after imlifidase dosing |
|
|
|
| Secondary | Number of PLEXs Needed Over Time | Number of PLEXs needed before anti-GBM antibodies are below toxic levels. PLEX was initiated at the discretion of the investigator throughout the study. | Posted | Number | Number of PLEX performed | Pre-screening and up to Day 93 after imlifidase dosing |
|
|
|
| Secondary | Pharmacokinetics of Imlifidase (Cmax) | Maximum observed plasma concentration of IdeS following dosing (Cmax) | Posted | Geometric Mean | Full Range | µg/mL | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 |
|
|
|
| Secondary | Pharmacokinetics of Imlifidase (AUC) | Area under the plasma concentration versus time curve (AUC) | Posted | Geometric Mean | Full Range | h*µg/mL | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 |
|
|
|
| Secondary | Pharmacokinetics of Imlifidase (t1/2) | Half-life during distribution phase (Alpha-t1/2) Half-life during elimination phase (Beta-t1/2) The results refers to harmonic mean. | Posted | Mean | Full Range | h | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 |
|
|
|
| Secondary | Pharmacokinetics of Imlifidase (CL) | Clearance (CL) is a measure of the ability of the body to clear imlifidase from plasma | Posted | Geometric Mean | Full Range | mL/h/kg | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 |
|
|
|
| Secondary | Pharmacokinetics of Imlifidase (Vz) | Vz = Volume of distribution during the elimination phase | Posted | Geometric Mean | Full Range | L/kg | Pre-dose, 45min, 2h, 6h, 24h, Day3, Day 7, Day 10, and Day15 |
|
|
|
| Secondary | Pharmacodynamics (IgG Degradation Measured as Remaining Concentration of Intact and Single Cleaved IgG) | Imlifidase specifically cleaves all subclasses of human IgG rapidly and efficiently. The cleaving process involves two steps: (i) intact IgG to single cleaved IgG followed by (ii) single cleaved IgG to completely cleaved IgG (one F(ab')2- and one homodimeric Fc-fragment) The electroluminescence analysis method used measures the sum of intact and single cleaved IgG in serum. The efficacy of imlifidase is evaluated as remaining concentration of intact and single cleaved IgG in serum after treatment. | Some patients had missing data at some timepoints | Posted | Mean | Standard Deviation | mg/mL | Pre-dose up to 6 months after imlifidase administration |
|
|
|
| Secondary | Anti-imlifidase Antibodies (ADA) | Determination of anti-imlifidase antibody concentration | Some missing data at Day 50, Day 93 and Day 180 | Posted | Mean | Standard Deviation | mg/L | Up to 6 months after dosing |
|
|
|
| Secondary | Renal Histology | Kidney biopsies were classified according to the histopathologic classification for antineutrophil cytoplasmic antibodies (ANCA)-associated glomerulonephritis developed by Berden et al. 2010. This classification has previously been applied in a study of 123 anti-GBM disease patients (von Daalen et al 2018). Histopathologic class:
Focal class is associated with favourable kidney outcome, whereas sclerotic carries a poor outcome. Crescentic/mixed class could have an intermediate outcome between focal and sclerotic. Immunofluorescence performed at the local hospitals was also used to assess linear IgG deposits which is a hallmark of anti-GBM antibody disease. | During the study, 14 kidney biopsies were taken from 10 of the 15 included patients. 10 biopsies were taken before administration of imlifidase and 4 after administration of imlifidase. | Posted | Number | Biopsies | Before administration of imlifidase (0-33 days) and after administration of imlifidase (3-6 days) | Biopsies | Biopsies |
|
|
|
| 15 |
| 5 |
| 15 |
| 15 |
| 15 |
| Vomiting | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (23.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (23.1) | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA (23.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Cryoglobulinaemia | Immune system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Clostridium difficile infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Blood iron decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Red blood cell count decreased | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Steroid diabetes | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (23.1) | Systematic Assessment |
|
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
| Pelvic venous thrombosis | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (23.1) | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (23.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (23.1) | Systematic Assessment |
|
| Anti-glomerular basement membrane antibody positive | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Borrelia test positive | Investigations | MedDRA (23.1) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (23.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (23.1) | Systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | MedDRA (23.1) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (23.1) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (23.1) | Systematic Assessment |
|
Not provided
Not provided
| eGFR at 6 months |
|
|
| eGFR (15-30) |
|
| eGFR (30-60) |
|
| eGFR (≥60) |
|
| Month 1 |
|
|
| Month 3 |
|
|
| Month 6 |
|
|
| Title | Measurements |
|---|---|
|
| 2 visits |
|
| 3 visits |
|
| 5 visits |
|
| 6 visits |
|
| 9 visits |
|
| 3 months |
|
|
| 6 months |
|
|
|
| Pre-imlifidase to Day 3 |
|
| Day 3 to Day 7 |
|
| Day 7 to Day 10 |
|
| Day 10 to Day 15 |
|
| Day 15 to Day 22 |
|
| Day 22 to Day 29 |
|
| Day 29 to Day 50 |
|
| Day 50 to Day 93 |
|
| Total (post-imlifidase to Day 93) |
|
| Total (pre-screening to Day 93) |
|
|
| 6 hours |
|
|
| 24 hours |
|
|
| Day 3 |
|
|
| Day 7 |
|
|
| Day 10 |
|
|
| Day 15 |
|
|
| Day 22 |
|
|
| Day 29 |
|
|
| Day 50 |
|
|
| Day 180 |
|
|
| Title | Measurements |
|---|---|
|
| Day 15 |
|
|
| Day 22 |
|
|
| Day 29 |
|
|
| Day 50 |
|
|
| Day 93 |
|
|
| Day 180 |
|
|
| Title | Measurements |
|---|
|
| Linear IgG deposits |
|