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

Kidney Transplant Failure and Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611621
• Other study ID #: 17-HMedIdeS-14
• Status: Completed
• Start date: June 27, 2018
• Est. completion date: February 14, 2023

Study information

• Verified date: February 2023
• Source: Hansa Biopharma AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 14, 2023
• Est. primary completion date: February 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Failure and Rejection

Intervention

Drug:
• Imlifidase
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.

Locations

Country	Name	City	State
France	Necker Hospital	Paris
Sweden	Karolinska University Hospital	Stockholm
Sweden	Uppsala University Hospital	Uppsala
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hansa Biopharma AB

Countries where clinical trial is conducted

United States,  France,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	5 years after first dose of imlifidase
Secondary	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
Secondary	Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of kidney function (eGFR).	Kidney function as evaluated by eGFR	5 years after first dose of imlifidase
Secondary	Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of kidney function (P-creatinine).	Kidney function as evaluated by P-creatinine	5 years after first dose of imlifidase
Secondary	Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of kidney function (proteinuria).	Kidney function as evaluated by proteinuria	5 years after first dose of imlifidase
Secondary	Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of number of graft rejection episodes.	Record graft rejection episodes (classified by Banff, Haas et al 2018)	5 years after first dose of imlifidase
Secondary	Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of treatment of graft rejection episodes.	Record graft rejection episodes treatments	5 years after first dose of imlifidase
Secondary	Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of comorbidities.	Record comorbidities	5 years after first dose of imlifidase
Secondary	Evaluation of long-term clinical outcomes of transplanted subjects treated with imlifidase in terms of treatments of comorbidities.	Record concomitant immunosuppressive medication	5 years after first dose of imlifidase
Secondary	Assessment of safety laboratory testing in terms of hematology (Hb)	Blood samples will be analysed for hemoglobulin (Hb)	5 years after first dose of imlifidase
Secondary	Assessment of safety laboratory testing in terms of hematology (differential analysis of leucocytes)	Differential analysis of leucocytes will be done in blood samples	5 years after first dose of imlifidase
Secondary	Assessment of safety laboratory testing in terms of hematology (thrombocytes)	Blood samples will be analysed for thrombocytes	5 years after first dose of imlifidase
Secondary	Assessment of safety laboratory testing in terms of total IgG	Blood samples will be analysed for total IgG levels.	5 years after first dose of imlifidase
Secondary	Assessment of donor specific antibodies (DSA)	DSA levels in blood samples will be analysed by SAB-HLA	5 years after first dose of imlifidase
Secondary	Assessment of the presence of BK virus	Blood samples will be analysed for antibodies towards BK virus	5 years after first dose of imlifidase
Secondary	Assessment of the immunogenicity of imlifidase	Serum samples will be analysed for anti-drug antibody (ADA) levels using an ImmunoCAP assay.	5 years after first dose of imlifidase
Secondary	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-5L	5 years after first dose of imlifidase
Secondary	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 KDQOL-SF	5 years after first dose of imlifidase