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

Study Timeline

• Study Start: 2018-06-27
• Study First Submitted: 2018-07-05
• Study First Submitted QC: 2018-07-26
• Study First Posted: 2018-08-02
• Status Verified: 2023-02
• Primary Completion: 2023-02-14
• Study Completion: 2023-02-14
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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

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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	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
Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of comorbidities.	5 years after first dose of imlifidase	Record comorbidities
Assessment of safety laboratory testing in terms of hematology (differential analysis of leucocytes)	5 years after first dose of imlifidase	Differential analysis of leucocytes will be done in blood samples
Assessment of the presence of BK virus	5 years after first dose of imlifidase	Blood samples will be analysed for antibodies towards BK virus
Assessment of the immunogenicity of imlifidase	5 years after first dose of imlifidase	Serum samples will be analysed 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 treatment of graft rejection episodes.	5 years after first dose of imlifidase	Record graft rejection episodes treatments
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	Record concomitant immunosuppressive medication
Assessment of safety laboratory testing in terms of hematology (thrombocytes)	5 years after first dose of imlifidase	Blood samples will be analysed for thrombocytes
Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of kidney function (eGFR).	5 years after first dose of imlifidase	Kidney function as evaluated by eGFR
Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of kidney function (P-creatinine).	5 years after first dose of imlifidase	Kidney function as evaluated by P-creatinine
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	Record graft rejection episodes (classified by Banff, Haas et al 2018)
Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of patient survival.	5 years after first dose of imlifidase	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 (proteinuria).	5 years after first dose of imlifidase	Kidney function as evaluated by proteinuria
Assessment of safety laboratory testing in terms of hematology (Hb)	5 years after first dose of imlifidase	Blood samples will be analysed for hemoglobulin (Hb)
Assessment of safety laboratory testing in terms of total IgG	5 years after first dose of imlifidase	Blood samples will be analysed for total IgG levels.
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	Health related quality of life (HR-QoL) as evaluated by patient questionnaires EQ-5D-5L
Assessment of donor specific antibodies (DSA)	5 years after first dose of imlifidase	DSA levels in blood samples will be analysed by SAB-HLA
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	Health related quality of life (HR-QoL) as evaluated by patient questionnaires KDQOL-SF

Trial Locations

Locations (6)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

New York University School of Medicine; 🇺🇸 New York, New York, United States

The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Necker Hospital; 🇫🇷 Paris, France

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden