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.
Study Type
OBSERVATIONAL
Enrollment
31
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.
Cedars-Sinai Medical Center
Los Angeles, California, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
New York University School of Medicine
New York, New York, United States
Necker Hospital
Paris, France
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
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.
Time frame: 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 Patient Survival.
Overall patient survival defined as time from transplantation to death for any cause
Time frame: 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)).
Kidney function as evaluated by estimated glomerular filtration rate (eGFR). eGFR was calculated according to the Modification of Diet in Renal Disease (MDRD) equation.
Time frame: 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
Time frame: 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
Time frame: 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): * a biopsy was taken at the time of the graft rejection episode * histological evidence of an AMR was reported in the pathology report * presence of detectable levels of donor specific antibodies (DSAs) and/or evidence of antibody-mediated morphological changes in the kidney transplant at the time of the biopsy
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years after first dose of imlifidase (in the feeder study)
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