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

Hansa Biopharma AB6 sites in 3 countries31 target enrollmentJune 27, 2018

ConditionsKidney Transplant Failure and Rejection

DrugsImlifidase

Overview

Phase: N/A
Intervention: Not specified
Conditions: Kidney Transplant Failure and Rejection
Sponsor: Hansa Biopharma AB
Enrollment: 31
Locations: 6
Primary Endpoint: Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 27, 2018

End Date

February 14, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Hansa Biopharma AB

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration.

Time Frame: 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 Outcomes

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))
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))
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))
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))
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))
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))
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))
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)
Assessment of Safety Laboratory Testing in Terms of Hematology (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)(5 years after first dose of imlifidase (in the feeder study))
Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes)(5 years after first dose of imlifidase (in the feeder study))
Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG)(5 years after first dose of imlifidase (in the feeder study))
Assessment of Donor Specific Antibodies (DSA)(5 years after first dose of imlifidase (in the feeder study))
Assessment of the Presence of BK Virus(5 years after first dose of imlifidase (in the feeder study))
Assessment of the Immunogenicity of 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 Quality of Life (EQ-5D-5L).(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).(5 years after first dose of imlifidase (in the feeder study))