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

Completed

Conditions: Kidney Transplant Failure and Rejection

Registration Number: NCT03611621

Lead Sponsor: Hansa Biopharma AB

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration.	5 years after first dose of imlifidase (in the feeder study)	The primary endpoint of this study is to determine overall graft survival, defined as time from transplantation to graft loss.

Secondary Outcome Measures

Name	Time	Method
Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes)	5 years after first dose of imlifidase (in the feeder study)	Differential analysis of leucocytes was done in blood samples
Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes)	5 years after first dose of imlifidase (in the feeder study)	Blood samples were analyzed for thrombocytes
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival.	5 years after first dose of imlifidase (in the feeder study)	Overall patient survival defined as time from transplantation to death for any cause
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)).	5 years after first dose of imlifidase (in the feeder study)	Kidney function as evaluated by estimated glomerular filtration rate (eGFR). eGFR was calculated according to the Modification of Diet in Renal Disease (MDRD) equation.
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine).	5 years after first dose of imlifidase (in the feeder study)	Kidney function as evaluated by analysis of plasma (P)-creatinine
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria).	5 years after first dose of imlifidase (in the feeder study)	Kidney function as evaluated by proteinuria by dipstick analysis
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes.	5 years after first dose of imlifidase (in the feeder study)	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
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes.	5 years after first dose of imlifidase (in the feeder study)	Recording of graft rejection episodes treatments (e.g. dialysis, plasmapheresis and medications).
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.	5 years after first dose of imlifidase (in the feeder study)	Recording of comorbidities up until year 5 after treatment with imlifidase
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities.	5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5	Recording of concomitant immunosuppressive medication
Assessment of Safety Laboratory Testing in Terms of Hematology (Hb)	5 years after first dose of imlifidase (in the feeder study)	Blood samples were analyzed for hemoglobulin (Hb)
Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG)	5 years after first dose of imlifidase (in the feeder study)	Blood samples were analyzed for total IgG levels.
Assessment of Donor Specific Antibodies (DSA)	5 years after first dose of imlifidase (in the feeder study)	DSA levels in blood samples were analyzed by Single Antigen Bead-Human Leukocyte Antigen (SAB-HLA) analysis
Assessment of the Presence of BK Virus	5 years after first dose of imlifidase (in the feeder study)	Blood samples were analyzed for antibodies towards BK virus
Assessment of the Immunogenicity of Imlifidase	5 years after first dose of imlifidase (in the feeder study)	Serum samples were analyzed for anti-drug antibody (ADA) levels using an ImmunoCAP assay.
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L).	5 years after first dose of imlifidase (in the feeder study)	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.
Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF).	5 years after first dose of imlifidase (in the feeder study)	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.

Trial Locations

Locations (6): Cedars-Sinai Medical Center
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Los Angeles, California, United States
New York University School of Medicine
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New York, New York, United States
The Johns Hopkins Hospital
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Baltimore, Maryland, United States
Necker Hospital
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Paris, France
Karolinska University Hospital
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Stockholm, Sweden
Uppsala University Hospital
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Uppsala, Sweden