A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Observational, Long Term Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation

Conditions
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Kidney Transplant Failure and Rejection

Intervention / Treatment
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* Drug: Imlifidase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent obtained before any study-related procedures Previous dosing with imlifidase followed by kidney transplantation and participation in one of the following clinical studies: 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS-04 or 15-HMedIdeS-06 Exclusion Criteria: Individuals deemed unable to comply with the protocol Inability by the judgment of the investigator to participate in the study for other reasons

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Imlifidase|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of kidney function (eGFR). | Kidney function as evaluated by eGFR | 5 years after first dose of imlifidase | 
| Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of kidney function (P-creatinine). | Kidney function as evaluated by P-creatinine | 5 years after first dose of imlifidase | 
| Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of kidney function (proteinuria). | Kidney function as evaluated by proteinuria | 5 years after first dose of imlifidase | 
| Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of number of graft rejection episodes. | Record graft rejection episodes (classified by Banff, Haas et al 2018) | 5 years after first dose of imlifidase | 
| Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of treatment of graft rejection episodes. | Record graft rejection episodes treatments | 5 years after first dose of imlifidase | 
| Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of comorbidities. | Record comorbidities | 5 years after first dose of imlifidase | 
| Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of treatments of comorbidities. | Record concomitant immunosuppressive medication | 5 years after first dose of imlifidase | 
| Assessment of safety laboratory testing in terms of hematology (Hb) | Blood samples will be analysed for hemoglobulin (Hb) | 5 years after first dose of imlifidase | 
| Assessment of safety laboratory testing in terms of hematology (differential analysis of leucocytes) | Differential analysis of leucocytes will be done in blood samples | 5 years after first dose of imlifidase | 
| Assessment of safety laboratory testing in terms of hematology (thrombocytes) | Blood samples will be analysed for thrombocytes | 5 years after first dose of imlifidase | 
| Assessment of safety laboratory testing in terms of total IgG | Blood samples will be analysed for total IgG levels. | 5 years after first dose of imlifidase | 
| Assessment of donor specific antibodies (DSA) | DSA levels in blood samples will be analysed by SAB-HLA | 5 years after first dose of imlifidase | 
| Assessment of the presence of BK virus | Blood samples will be analysed for antibodies towards BK virus | 5 years after first dose of imlifidase | 
| Assessment of the immunogenicity of imlifidase | Serum samples will be analysed for anti-drug antibody (ADA) levels using an ImmunoCAP assay. | 5 years after first dose of imlifidase | 
| 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-5L | 5 years after first dose of imlifidase | 
| 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 KDQOL-SF | 5 years after first dose of imlifidase |