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The purpose of this study is to evaluate the effectiveness of the study drug IdeS in patients who are on the waiting list for kidney transplant and have previously undergone desensitization unsuccessfully or in whom effective desensitization will be highly unlikely. At study entry, the patients will have an available deceased or live donor with a positive crossmatch test. The study will assess IdeS efficacy and safety in removing Donor Specific Antibodies (DSAs) and thereby convert a positive crossmatch test to negative.
The study will assess the IdeS efficacy in creating a negative crossmatch test (XM) in patients who exhibit donor specific antibodies (DSA) and have a positive crossmatch test to their available live or deceased donors. The first 3 patients in this study will receive a kidney from a deceased donor. The study will primarily examine the efficacy of IdeS in creating a negative XM. The first 3 patients will receive one dose of 0.25 mg/kg BW IdeS on study day 0. If it is considered safe and negative crossmatch test is not achieved after the first dose, an additional IdeS infusion can be given within 2 days of the first infusion. The dose schedule may be increased to 0.5 mg/kg BW given once or twice after the first 3 patients have been tested. The decision to escalate the dose will be done after evaluation of safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment IdeS | Experimental | IdeS intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IdeS | Drug | One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Crossmatch Conversion (Positive to Negative) | IdeS ability to create a negative crossmatch (XM) test in patients who before treatment exhibit Donor Specific Antibodies (DSAs) and have a positive XM test to their available live or deceased donor kidney. XM was assessed using both FACS and CDC XM tests. FACS XM is a multi-staining procedure where the recipient's serum is used to stain donor cells to identify presence of DSAs in recipient's serum. T- and B-cells are identified using conjugated antibodies against CD3 and CD19. DSAs are identified using a conjugated anti-human antibody. CDC XM evaluates the cytotoxic capacity of the DSAs. The recipient's serum is mixed with donor cells prior to addition of complement. Fluorescent dyes are added and the live/dead cells (%) is scored using a fluorescent microscope. CDC XM amplified with anti-human globulin is not compatible with imlifidase and should not be used. The endpoint was met if at least one XM test was positive pre-dose and the last test within 24 h was negative. | Within 24 hours of IdeS dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Donor Specific Antibodies With an MFI Value >3000 | Donor specific antibodies (DSA) level at different time points within 180 days after administration of IdeS. DSA levels were measured using the single antigen beads (SAB) anti-HLA assay. The levels were determined as mean fluorescence intensity (MFI). Positive DSA (i.e. HLA antibodies) were defined as having a MFI value >3000. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lena Winstedt, PhD | Hansa Biopharma AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| The Johns Hopkins Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41394519 | Derived | Lorant T, Lonze BE, Montgomery RA, Desai NM, Legendre C, Lundgren T, von Zur-Muhlen B, Vo AA, Sjoholm K, Runstrom A, Tollemar J, Jordan SC. Five Years Follow-up of Imlifidase Desensitized Kidney Transplant Recipients. Transpl Int. 2025 Nov 27;38:15425. doi: 10.3389/ti.2025.15425. eCollection 2025. | |
| 39802198 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | One Dose of IdeS (0.25 mg/kg BW) | One (1) IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment |
| FG001 | Two Doses of IdeS (2 x 0.25 mg/kg BW) | Two (2) IdeS intravenous infusions IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | One Dose of IdeS (0.25 mg/kg BW) | IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment |
| BG001 | Two Doses of IdeS (2 x 0.25 mg/kg BW) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Crossmatch Conversion (Positive to Negative) | IdeS ability to create a negative crossmatch (XM) test in patients who before treatment exhibit Donor Specific Antibodies (DSAs) and have a positive XM test to their available live or deceased donor kidney. XM was assessed using both FACS and CDC XM tests. FACS XM is a multi-staining procedure where the recipient's serum is used to stain donor cells to identify presence of DSAs in recipient's serum. T- and B-cells are identified using conjugated antibodies against CD3 and CD19. DSAs are identified using a conjugated anti-human antibody. CDC XM evaluates the cytotoxic capacity of the DSAs. The recipient's serum is mixed with donor cells prior to addition of complement. Fluorescent dyes are added and the live/dead cells (%) is scored using a fluorescent microscope. CDC XM amplified with anti-human globulin is not compatible with imlifidase and should not be used. The endpoint was met if at least one XM test was positive pre-dose and the last test within 24 h was negative. | The full analysis set (FAS) comprises data from all patients in the safety analysis set (SAS) with available post-dose efficacy data. Before analysis it was specified that the analysis set should include all patients combined who had received the planned dose which was defined as 1 administration initially which could be repeated if needed. The single as well as the repeated administration are defined as the only planned dose. Consequently, the results are presented for all patients together. | Posted | Number | Patients |
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, including the follow-up period).
Data on AEs were obtained if spontaneously reported by the patient, if reported in response to an open question from the study personnel or if revealed by observation.
A treatment emergent adverse event (TEAE) was defined as any AE occurring after the administration of IdeS and within the time of the residual drug effect period (i.e. 30 days after IMP administration).
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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 | SAS - One Dose of IdeS (0.25 mg/kg BW) | One (1) IdeS intravenous infusion IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. Kidney transplantation: Performed following IdeS treatment The SAS consists of all patients dosed with any amount of IdeS. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Axillary vein thrombosis | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep vein thrombosis | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth Sonesson, Director Clinical Operations | Hansa Biopharma AB | +46 (0)708 54 86 46 | elisabeth.sonesson@hansabiopharma.com |
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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 | Mar 20, 2017 | Feb 22, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2018 | Feb 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D016030 | Kidney Transplantation |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
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|
| Kidney transplantation | Procedure | Performed following IdeS treatment |
|
| Within 180 days after administration of IdeS. |
| Time to Create a Negative CDC Crossmatch Test | Time to create a negative CDC crossmatch (XM) was defined as the first timepoint all CDC XM results were negative. | 2h, 6h, 24h after administration of IdeS. |
| Time to Create a Negative FACS Crossmatch Test | Time to create a negative FACS crossmatch (XM) was defined as the first timepoint all FACS XM results were negative. | 2h, 6h, and 24h after administration of IdeS |
| Kidney Function After IdeS Treatment Assessed by eGFR | Estimated glomerular filtration rate (eGFR) was calculated as described by the MDRD equation. eGFR is a measure of kidney function. eGFR for a kidney with normal function is 90 mL/min/1.72m2. Kidney disease is characterised by a decreased eGFR value. | Within 180 days after administration of IdeS |
| Serum IgG Concentration After Administration of IdeS | The patient's immunoglobulin G (IgG) is cleaved by IdeS in two steps. The first cut separates one of the heavy chains from the Fc part, generating so called single-cleaved IgG (scIgG), and the second cut separates the other heavy chain from the Fc part, thus generating one F(ab')2 fragment and one Fc fragment. The IgG concentration measured for this outcome is the sum of intact and scIgG because the assay used cannot discriminate between the two. A decrease in IgG concentration therefore represents complete cleavage of the IgG molecules to Fc and F(ab')2 fragments. Please note that intravenous IgG (IVIg) was administered Day 7. | Within 180 days after administration of IdeS. |
| Pharmacokinetics - Cmax (First Dose) | Cmax = Maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis) | Pre-dose to Day 14 after administration of IdeS. |
| Pharmacokinetics - Cmax (Second Dose) | Cmax = Maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis) | Pre-dose until Day 14 after administration of IdeS |
| Pharmacokinetics - Tmax (First Dose) | Tmax = Time point for maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis) | Pre-dose to Day 14 after administration of IdeS |
| Pharmacokinetics - Tmax (Second Dose) | Tmax = Time point for maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis) | Pre-dose to Day 14 after administration of IdeS |
| Pharmacokinetics - AUC | AUC = Area under the plasma concentration versus time curve (Non-compartmental PK analysis) | Pre-dose to Day 14 after administration of IdeS. |
| Pharmacokinetics - t1/2 | Alpha-t1/2 = Half-life during distribution phase Beta-t1/2 = Half-life during elimination phase Non-compartmental PK analysis | Pre-dose to Day 14 after administration of IdeS. |
| Pharmacokinetics - CL | CL = Clearance Non compartmental PK analysis | Pre-dose to Day 14 |
| Pharmacokinetics - Vss | Vss = Volume of distribution at steady state Non compartmental PK analysis | Pre-dose to Day 14 after administration of IdeS |
| Pharmacokinetics - Vz | Vz = Volume of distribution during the elimination phase Non compartmental PK analysis | Pre-dose to Day 14 after administration of IdeS. |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Necker Hospital | Paris | 75743 | France |
| Uppsala University Hospital | Uppsala | 75185 | Sweden |
| Jaffe IS, Runstrom A, Tatapudi VS, Weldon EP, Deterville CL, Dieter RA, Montgomery RA, Lonze BE, Mangiola M. Clinical Outcomes and Donor-specific Antibody Rebound 5 y After Kidney Transplant Enabled by Imlifidase Desensitization. Transplant Direct. 2025 Jan 9;11(2):e1752. doi: 10.1097/TXD.0000000000001752. eCollection 2025 Feb. |
| 34236770 | Derived | Kjellman C, Maldonado AQ, Sjoholm K, Lonze BE, Montgomery RA, Runstrom A, Lorant T, Desai NM, Legendre C, Lundgren T, von Zur Muhlen B, Vo AA, Olsson H, Jordan SC. Outcomes at 3 years posttransplant in imlifidase-desensitized kidney transplant patients. Am J Transplant. 2021 Dec;21(12):3907-3918. doi: 10.1111/ajt.16754. Epub 2021 Jul 19. |
| 33093408 | Derived | Jordan SC, Legendre C, Desai NM, Lorant T, Bengtsson M, Lonze BE, Vo AA, Runstrom A, Laxmyr L, Sjoholm K, Schiott A, Sonesson E, Wood K, Winstedt L, Kjellman C, Montgomery RA. Imlifidase Desensitization in Crossmatch-positive, Highly Sensitized Kidney Transplant Recipients: Results of an International Phase 2 Trial (Highdes). Transplantation. 2021 Aug 1;105(8):1808-1817. doi: 10.1097/TP.0000000000003496. |
| Withdrawal by Subject |
|
Two (2) IdeS intravenous infusions
IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion.
Kidney transplantation: Performed following IdeS treatment
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Median | Full Range | kg |
|
| Within 24 hours of IdeS dosing |
|
|
|
| Secondary | Number of Patients With Donor Specific Antibodies With an MFI Value >3000 | Donor specific antibodies (DSA) level at different time points within 180 days after administration of IdeS. DSA levels were measured using the single antigen beads (SAB) anti-HLA assay. The levels were determined as mean fluorescence intensity (MFI). Positive DSA (i.e. HLA antibodies) were defined as having a MFI value >3000. | The per protocol (PP) set comprises all patients in the SAS with >1 post dose result. Data excluded for patients with >1 protocol deviation. 1 patient lost the graft D77. Before analysis it was specified that the PP set should include all patients combined who had received the planned dose defined as 1 admin. initially which could be repeated if needed. The single as well as the repeated admin. are defined as the only planned dose. Hence, the results are presented for all patients together. | Posted | Number | Patients with DSA (MFI>3000) | Within 180 days after administration of IdeS. |
|
|
|
| Secondary | Time to Create a Negative CDC Crossmatch Test | Time to create a negative CDC crossmatch (XM) was defined as the first timepoint all CDC XM results were negative. | The full analysis set (FAS) comprises data from all patients in the safety analysis set (SAS) with available post-dose efficacy data. Before analysis it was specified that the analysis set should include all patients combined who had received the planned dose which was defined as 1 administration initially which could be repeated if needed. The single as well as the repeated administration are defined as the only planned dose. Consequently, the results are presented for all patients together. | Posted | Count of Participants | Participants | 2h, 6h, 24h after administration of IdeS. |
|
|
|
| Secondary | Time to Create a Negative FACS Crossmatch Test | Time to create a negative FACS crossmatch (XM) was defined as the first timepoint all FACS XM results were negative. | The full analysis set (FAS) comprises data from all patients in the safety analysis set (SAS) with available post-dose efficacy data. Before analysis it was specified that the analysis set should include all patients combined who had received the planned dose which was defined as 1 administration initially which could be repeated if needed. The single as well as the repeated administration are defined as the only planned dose. Consequently, the results are presented for all patients together. | Posted | Count of Participants | Participants | 2h, 6h, and 24h after administration of IdeS |
|
|
|
| Secondary | Kidney Function After IdeS Treatment Assessed by eGFR | Estimated glomerular filtration rate (eGFR) was calculated as described by the MDRD equation. eGFR is a measure of kidney function. eGFR for a kidney with normal function is 90 mL/min/1.72m2. Kidney disease is characterised by a decreased eGFR value. | The per protocol (PP) set comprises all patients in the SAS with >1 post dose result. Data excluded for patients with >1 protocol deviation. 1 patient lost the graft D77. Before analysis it was specified that the PP set should include all patients combined who had received the planned dose defined as 1 admin. initially which could be repeated if needed. The single as well as the repeated admin. are defined as the only planned dose. Hence, the results are presented for all patients together. | Posted | Count of Participants | Participants | Within 180 days after administration of IdeS |
|
|
|
| Secondary | Serum IgG Concentration After Administration of IdeS | The patient's immunoglobulin G (IgG) is cleaved by IdeS in two steps. The first cut separates one of the heavy chains from the Fc part, generating so called single-cleaved IgG (scIgG), and the second cut separates the other heavy chain from the Fc part, thus generating one F(ab')2 fragment and one Fc fragment. The IgG concentration measured for this outcome is the sum of intact and scIgG because the assay used cannot discriminate between the two. A decrease in IgG concentration therefore represents complete cleavage of the IgG molecules to Fc and F(ab')2 fragments. Please note that intravenous IgG (IVIg) was administered Day 7. | The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. At Day 180 data was available for 7 patients receiving one dose and 1 patient receiving two doses. | Posted | Geometric Mean | Geometric Coefficient of Variation | mg/mL | Within 180 days after administration of IdeS. |
|
|
|
| Secondary | Pharmacokinetics - Cmax (First Dose) | Cmax = Maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis) | The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. The concentration vs time profiles for all 18 patients, including the 3 patients who received a second dose, were used to calculate Cmax after first dose. Cmax after the first dose occurred before the second dose was administered. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/mL | Pre-dose to Day 14 after administration of IdeS. |
|
|
|
| Secondary | Pharmacokinetics - Cmax (Second Dose) | Cmax = Maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis) | The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. The 3 patients received their second dose 11-13 hours after the first dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/mL | Pre-dose until Day 14 after administration of IdeS |
|
|
|
| Secondary | Pharmacokinetics - Tmax (First Dose) | Tmax = Time point for maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis) | The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. (The mean result presented refers to the arithmetic mean) The concentration vs time profiles for all 18 patients, including the 3 patients who received a second dose, were used to calculate Tmax for the first dose. Cmax/Tmax for the first dose occurred before the second dose was administered. | Posted | Mean | Standard Deviation | hours | Pre-dose to Day 14 after administration of IdeS |
|
|
|
| Secondary | Pharmacokinetics - Tmax (Second Dose) | Tmax = Time point for maximum observed plasma concentration of IdeS following dosing (Non-compartmental PK analysis) | The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. The 3 subjects received their second dose 11-13 hours after the first dose. Tmax for the second dose was calculated from the start of the first dose. (The mean result presented refers to the arithmetic mean.) | Posted | Mean | Standard Deviation | hours | Pre-dose to Day 14 after administration of IdeS |
|
|
|
| Secondary | Pharmacokinetics - AUC | AUC = Area under the plasma concentration versus time curve (Non-compartmental PK analysis) | The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. Data available for 9 patients only who all received 1 dose of IdeS. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*microgram/mL | Pre-dose to Day 14 after administration of IdeS. |
|
|
|
| Secondary | Pharmacokinetics - t1/2 | Alpha-t1/2 = Half-life during distribution phase Beta-t1/2 = Half-life during elimination phase Non-compartmental PK analysis | The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. Data available for 9 patients only who all received 1 dose of IdeS. (The mean result refers to the harmonic mean.) | Posted | Mean | Standard Deviation | hours | Pre-dose to Day 14 after administration of IdeS. |
|
|
|
| Secondary | Pharmacokinetics - CL | CL = Clearance Non compartmental PK analysis | The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. Data available for 9 patients only who all received 1 dose of IdeS. | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/h/kg | Pre-dose to Day 14 |
|
|
|
| Secondary | Pharmacokinetics - Vss | Vss = Volume of distribution at steady state Non compartmental PK analysis | The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. Data available for 9 patients only who all received 1 dose of IdeS. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/kg | Pre-dose to Day 14 after administration of IdeS |
|
|
|
| Secondary | Pharmacokinetics - Vz | Vz = Volume of distribution during the elimination phase Non compartmental PK analysis | The Per Protocol (PP) analysis set consists of all patients in the safety set who had at least one efficacy endpoint value. Data from patients with one or more major protocol deviations were excluded. Data available for 9 patients only who all received 1 dose of IdeS | Posted | Geometric Mean | Geometric Coefficient of Variation | L/kg | Pre-dose to Day 14 after administration of IdeS. |
|
|
|
| 0 |
| 16 |
| 12 |
| 16 |
| 15 |
| 16 |
| EG001 | SAS - Two Doses of IdeS (2 x 0.25 mg/kg BW) | Two (2) IdeS intravenous infusions IdeS: First dose of 0.25 mg/kg BW IdeS on study day 0. Second dose of 0.25 mg/kg BW within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment. The SAS consists of all patients dosed with any amount of IdeS. | 0 | 3 | 3 | 3 | 3 | 3 |
| EG002 | SAS - All Patients (One or Two Doses of IdeS (0.25 mg/kg BW)) | One (1) or two (2) IdeS intravenous infusions. IdeS: One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion. Kidney transplantation: Performed following IdeS treatment. The SAS consists of all patients dosed with any amount of IdeS. | 0 | 19 | 15 | 19 | 18 | 19 |
| Superior vena cava syndrome | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Transplant failure | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Weaning failure | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Blood creatine increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Donor specific antibody present | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Transplant rejection | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Thrombotic microangiopathy | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Glomerulonephritis | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nephropathy toxic | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Enterococcal bacteraemia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Perinephric abscess | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Jugular vein thrombosis | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypogammaglobulinaemia | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Transplant rejection | Immune system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Administration site pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Application site pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Breakthrough pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Catheter site haemorrhage | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Haemorrhagic cyst | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (18.1) | Systematic Assessment |
|
| Allergic transfusion reaction | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Complications of transplant surgery | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Delayed graft function | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Renal lymphocele | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Clostridium test positive | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Donor specific antibody present | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Hepatitis B core antibody positive | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Respiratory rate decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Sapovirus test positive | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Urine output decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Throat lesion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Tongue paralysis | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Perianal erythema | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Renal cyst haemorrhage | Renal and urinary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hepatocellular injury | Hepatobiliary disorders | MedDRA (18.1) | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA (18.1) | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Fluid retention | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Magnesium deficiency | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (18.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Cytomegalovirus viraemia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Perinephric abscess | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Pyuria | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Viraemia | Infections and infestations | MedDRA (18.1) | 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 Medical AB.
Any confidential information relating to the IMP or the study, including any data and results from the study will be the exclusive property of Hansa Medical AB. The investigator and any other persons involved in the trial will protect the confidentiality of the proprietary information belonging to Hansa Medical AB.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
|
| 6 h |
|
|
| 24 h |
|
|
| 48 h |
|
|
| 96 h |
|
|
| Day 7 |
|
|
| Day 14 |
|
|
| Day 28 |
|
|
| Day 90 |
|
|
| Day 180 |
|
|
| Remained positive |
|
| eGFR: >60 ml/min/1.72m2 |
|
| Day 90 |
|
|
| Day 180 |
|
|
| IgG concentration (2 h) |
|
|
| IgG concentration (6 h) |
|
|
| IgG concentration (24 h) |
|
|
| IgG concentration (48 h) |
|
|
| IgG concentration (Day 7 before IVIg) |
|
|
| IgG concentration (Day 7 after IVIg) |
|
|
| IgG concentration (Day 9) |
|
|
| IgG concentration (Day 14) |
|
|
| IgG concentration (Day 21) |
|
|
| IgG concentration (Day 28) |
|
|
| IgG concentration (Day 64) |
|
|
| IgG concentration (Day 180) |
|
|