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

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 Overview

• Status: Completed
• Conditions: Kidney Transplant Failure and Rejection
• Intervention / Treatment: Drug: Imlifidase

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• France
  • Paris, France, 75743
    • Necker Hospital
• Sweden
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital
  • Uppsala, Sweden, 751 85
    • Uppsala university hospital
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • The Johns Hopkins Hospital
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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 (in the feeder study)

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 (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.	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): 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	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)

Collaborators and Investigators

• Sponsor: Hansa Biopharma AB
• Investigators: Study Director: Clinical Operations, Hansa Biopharma AB

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2018
• Primary Completion (Actual): February 14, 2023
• Study Completion (Actual): February 14, 2023

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 17-HMedIdeS-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No