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The rationale for the current protocol is to collect data from extended follow up in subjects that have received a kidney transplant following imlifidase dosing to provide a better understanding regarding the long-term outcome for these subjects. Data of parameters such as patient and graft survival, comorbidity, treatment of graft rejection episodes and quality of life as well as anti-drug antibody levels will be collected.
This prospective, observational follow up study of subjects who have received imlifidase prior to kidney transplantation will provide important data to future prescribers and patients of the potential long-term benefits of imlifidase mediated transplantation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imlifidase | Drug | This is a five year, long-term follow up, observational study. The study will primarily determine the time of graft survival in subjects who have received imlifidase prior to kidney transplantation. Subjects who have participated, or are currently participating, in the imlifidase kidney transplantation studies (called feeder studies) 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS- 04 and 15-HMedIdeS-06 will be included. The subjects will attend 4 follow up visits, 1, 2, 3 and 5 years after imlifidase administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration. | The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss. | 5 years after first dose of imlifidase (in the feeder study) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival. | Overall patient survival defined as time from transplantation to death for any cause | 5 years after first dose of imlifidase (in the feeder study) |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)). |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects that have participated, or are currently participating, in the imlifidase kidney transplantation studies; 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 and 15-HMedIdeS-06 will be included.
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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 | ||
| 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. |
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Data from patients who died (n=3) or had lost their graft (n=3) after the end of the feeder study but prior to being enrolled in the current trial, were included in the data analysis after ethics permission i.e. data from 37 patients was analyzed.
Long-term follow-up of patients participating in the imlifidase kidney transplantation studies (feeder studies) 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 and 15-HMedIdeS-06. The patients attend 4 follow up visits, 1, 2, 3 and 5 years after imlifidase administration. Up to 46 patients could be included depending on patients' willingness to participate in the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Imlifidase | All patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data at time of enrollment in feeder studies
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| ID | Title | Description |
|---|---|---|
| BG000 | Imlifidase | All patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration. | The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss. | The primary endpoint, overall graft survival, was analyzed by the Kaplan-Meier survival method and presented with 95% confidence limits. The following events were censored at the time of occurrence: withdrawal from the trial without graft loss, death not caused by graft loss, and end of trial without graft loss. | Posted | Number | 95% Confidence Interval | percentage | 5 years after first dose of imlifidase (in the feeder study) |
|
Adverse events (AEs) related to trial procedures or to clinically significant safety laboratory values were recorded from time of informed consent to end of trial, up to 4y and 6m. AEs were not collected for the 6 patients that had lost their graft (n=3) or who died (n=3) after the end of the feeder trials, since these patients were not actively enrolled in the current trial. In the feeder trials AEs were recorded for each patient from time of informed consent to end of trial, up to 6 months.
Only AEs related to trial procedures or to clinically significant safety laboratory values were to be reported in the trial. No AEs or serious adverse events (SAEs) were reported in the trial however 3 graft losses (1 due to infection,1 immunosuppression non-adherence, 1 rejection/loss of function) and 3 deaths (1 circulatory arrest, 1 pseudomonas bacteremia, 1 unknown reason) occurred after the completion of the feeder trials. None of these patients were actively enrolled in the current trial.
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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 | All patients Note: AEs were not collected for the patients that lost their graft (n=3) or who died (n=3) after the end of the feeder trials, since they were not actively enrolled in the current trial. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Hansa Biopharma AB | +46 46 16 56 70 | clinicalstudyinfo@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 | Nov 22, 2021 | Jan 26, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 4, 2023 | Jan 26, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C442815 | Mac-1-like protein, Streptococcus |
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Blood samples (storage time: maximum 2 years after completion of the study report according to local regulations)
Kidney function as evaluated by estimated glomerular filtration rate (eGFR). eGFR was calculated according to the Modification of Diet in Renal Disease (MDRD) equation. |
| 5 years after first dose of imlifidase (in the feeder study) |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine). | Kidney function as evaluated by analysis of plasma (P)-creatinine | 5 years after first dose of imlifidase (in the feeder study) |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria). | Kidney function as evaluated by proteinuria by dipstick analysis | 5 years after first dose of imlifidase (in the feeder study) |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes. | Recording of occurrence of graft rejection episodes classified by Banff criteria (Haas et al 2018). The following criteria had to be fulfilled by the rejection episode to constitute an antibody-mediated rejection (AMR):
| 5 years after first dose of imlifidase (in the feeder study) |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes. | Recording of graft rejection episodes treatments (e.g. dialysis, plasmapheresis and medications). | 5 years after first dose of imlifidase (in the feeder study) |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities. | Recording of comorbidities up until year 5 after treatment with imlifidase | 5 years after first dose of imlifidase (in the feeder study) |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities. | Recording of concomitant immunosuppressive medication | 5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5 |
| Assessment of Safety Laboratory Testing in Terms of Hematology (Hb) | Blood samples were analyzed for hemoglobulin (Hb) | 5 years after first dose of imlifidase (in the feeder study) |
| Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes) | Differential analysis of leucocytes was done in blood samples | 5 years after first dose of imlifidase (in the feeder study) |
| Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes) | Blood samples were analyzed for thrombocytes | 5 years after first dose of imlifidase (in the feeder study) |
| Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG) | Blood samples were analyzed for total IgG levels. | 5 years after first dose of imlifidase (in the feeder study) |
| Assessment of Donor Specific Antibodies (DSA) | DSA levels in blood samples were analyzed by Single Antigen Bead-Human Leukocyte Antigen (SAB-HLA) analysis | 5 years after first dose of imlifidase (in the feeder study) |
| Assessment of the Presence of BK Virus | Blood samples were analyzed for antibodies towards BK virus | 5 years after first dose of imlifidase (in the feeder study) |
| Assessment of the Immunogenicity of Imlifidase | Serum samples were analyzed for anti-drug antibody (ADA) levels using an ImmunoCAP assay. | 5 years after first dose of imlifidase (in the feeder study) |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L). | Health related quality of life (HR-QoL) as evaluated by patient questionnaires EQ-5D-5 levels (5L) EQ-5D-5L index score values were calculated from individual health profiles by using the corresponding EQ-5D-5L crosswalk value set per country where a higher value correspond to better health. Index score value ranges per country: USA [-0.109 - 1.000], France [-0.530 - 1.000], Denmark [-0.624 - 1.000], since no index score values exist for Sweden, values for Denmark were used for patients from Sweden. The visual analogue scale (EQ VAS) score was graded from 0 (the worst imaginable health) to 100 (the best imaginable health), where higher scores correspond to better health. | 5 years after first dose of imlifidase (in the feeder study) |
| Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF). | Health related quality of life (HR-QoL) as evaluated by patient questionnaires Kidney Disease Quality of Life Questionnaire-short form (KDQOL-SF) Scores of different subscales were calculated according to the KDQOL-36 scoring program. The scale range for each subscale is 0 to 100, with higher scores indicating better quality of life. | 5 years after first dose of imlifidase (in the feeder study) |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| New York University School of Medicine | New York | New York | 10016 | United States |
| Necker Hospital | Paris | 75743 | France |
| Karolinska University Hospital | Stockholm | 17176 | Sweden |
| Uppsala University Hospital | Uppsala | 751 85 | Sweden |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival. | Overall patient survival defined as time from transplantation to death for any cause | The overall patient survival was analyzed by the Kaplan-Meier survival method and presented with 95% confidence limits. The following events were censored: withdrawal from the trial while alive, and end of trial while alive | Posted | Number | 95% Confidence Interval | percentage | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)). | Kidney function as evaluated by estimated glomerular filtration rate (eGFR). eGFR was calculated according to the Modification of Diet in Renal Disease (MDRD) equation. | Patients with a visit/assessment at year 5 | Posted | Mean | Standard Deviation | mL/min/1.73m2 | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine). | Kidney function as evaluated by analysis of plasma (P)-creatinine | Patients with a visit/assessment at year 5 | Posted | Mean | Standard Deviation | μmol/L | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria). | Kidney function as evaluated by proteinuria by dipstick analysis | Patients with a visit/assessment at year 5 | Posted | Count of Participants | Participants | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes. | Recording of occurrence of graft rejection episodes classified by Banff criteria (Haas et al 2018). The following criteria had to be fulfilled by the rejection episode to constitute an antibody-mediated rejection (AMR):
| Patients with a visit/assessment at year 5. Note: number of patients with suspected acute rejection episodes up until year 5. One (1) biopsy confirmed rejection episode (AMR) was reported for 1 patient approx. 9 months after transplantation. One (1) biopsy confirmed rejection episode reported in the current trial occurred in the feeder trial. Five (5) rejection episodes were not confirmed by biopsy. | Posted | Count of Participants | Participants | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes. | Recording of graft rejection episodes treatments (e.g. dialysis, plasmapheresis and medications). | Patients with a visit/assessment at year 5. Any medication (e.g. Intravenous immunoglobulin [IVIg]) given for graft rejection episodes | Posted | Count of Participants | Participants | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities. | Recording of comorbidities up until year 5 after treatment with imlifidase | All patients with a comorbidity reported. Note: any single patient could have more than one comorbidity reported. | Posted | Number | participants with comorbidity | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities. | Recording of concomitant immunosuppressive medication | Immunosuppressive medications were recorded for 30 of the 31 patients enrolled | Posted | Number | participants | 5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5 |
|
|
|
| Secondary | Assessment of Safety Laboratory Testing in Terms of Hematology (Hb) | Blood samples were analyzed for hemoglobulin (Hb) | All patients with a visit/assessment at year 5 | Posted | Mean | Standard Deviation | g/L | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes) | Differential analysis of leucocytes was done in blood samples | All patients with a visit/assessment at year 5. Note: not all patients had an assessment reported at year 5. | Posted | Mean | Standard Deviation | percentage | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes) | Blood samples were analyzed for thrombocytes | All patients with a visit/assessment at year 5 | Posted | Mean | Standard Deviation | 10^9 thrombocytes/L | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG) | Blood samples were analyzed for total IgG levels. | All patients with a visit/assessment at year 5. | Posted | Mean | Standard Deviation | g/L | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Assessment of Donor Specific Antibodies (DSA) | DSA levels in blood samples were analyzed by Single Antigen Bead-Human Leukocyte Antigen (SAB-HLA) analysis | All patients with a visit/assessment at year 5 | Posted | Mean | Standard Deviation | Mean fluorescence intensity (MFI) | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Assessment of the Presence of BK Virus | Blood samples were analyzed for antibodies towards BK virus | All patients with a visit/assessment at year 5 | Posted | Number | participants | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Assessment of the Immunogenicity of Imlifidase | Serum samples were analyzed for anti-drug antibody (ADA) levels using an ImmunoCAP assay. | All patients with a visit/assessment at year 5 | Posted | Mean | Standard Deviation | mg/L | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L). | Health related quality of life (HR-QoL) as evaluated by patient questionnaires EQ-5D-5 levels (5L) EQ-5D-5L index score values were calculated from individual health profiles by using the corresponding EQ-5D-5L crosswalk value set per country where a higher value correspond to better health. Index score value ranges per country: USA [-0.109 - 1.000], France [-0.530 - 1.000], Denmark [-0.624 - 1.000], since no index score values exist for Sweden, values for Denmark were used for patients from Sweden. The visual analogue scale (EQ VAS) score was graded from 0 (the worst imaginable health) to 100 (the best imaginable health), where higher scores correspond to better health. | All patients with a visit/assessment at year 5 | Posted | Median | Full Range | score on a scale | 5 years after first dose of imlifidase (in the feeder study) |
|
|
|
| Secondary | Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF). | Health related quality of life (HR-QoL) as evaluated by patient questionnaires Kidney Disease Quality of Life Questionnaire-short form (KDQOL-SF) Scores of different subscales were calculated according to the KDQOL-36 scoring program. The scale range for each subscale is 0 to 100, with higher scores indicating better quality of life. | All patients with a visit/assessment at year 5 | Posted | Mean | Standard Deviation | score on a scale | 5 years after first dose of imlifidase (in the feeder study) |
|
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| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
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| Title | Measurements |
|---|
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| upper respiratory infection |
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| Covid-19 infection |
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| urosepsis |
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| sepsis |
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| pneumonia |
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| diabetes mellitus |
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| Title |
|---|
| Measurements |
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| Prednisone/prednisolone |
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| Lymphocytes/Leucocytes |
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| Monocytes/Leucocytes |
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| Neutrophils/Leucocytes |
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| EQ-5D-5L index value France |
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| EQ-5D-5L index value Sweden |
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| Title | Measurements |
|---|---|
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| Cognitive function |
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| Physical functioning |
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| Work status |
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