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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03611621

Enrollment

Registered

2018-08-02

Start date

2018-06-27

Completion date

2023-02-14

Last updated

2025-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Failure and Rejection

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.

Interventions

DRUGImlifidase

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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
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
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.
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

Countries

France, Sweden, United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
Imlifidase All patients	37
Total	37

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	3
Overall Study	Graft loss	3
Overall Study	Lost to Follow-up	1

Baseline characteristics

Characteristic	Imlifidase
Age, Continuous	44.5 years STANDARD_DEVIATION 12.9
Body mass index (BMI)	24.2 kg/m2 STANDARD_DEVIATION 3.8
Height	171.4 cm STANDARD_DEVIATION 10.1
Race/Ethnicity, Customized Race Asian	4 Participants
Race/Ethnicity, Customized Race Black or African American	4 Participants
Race/Ethnicity, Customized Race Other	2 Participants
Race/Ethnicity, Customized Race White	27 Participants
Region of Enrollment France	2 participants
Region of Enrollment Sweden	13 participants
Region of Enrollment United States	22 participants
Sex: Female, Male Female	17 Participants
Sex: Female, Male Male	20 Participants
Weight	72.2 kg STANDARD_DEVIATION 15.1

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 31
other Total, other adverse events	0 / 31
serious Total, serious adverse events	0 / 31

Outcome results

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.