Clinical trial NCT03611621: A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
Official title: A Prospective Observational, Long Term Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant Failure and Rejection
Lead sponsor: Hansa Biopharma AB
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Evaluation of Graft Survival in Subjects Who Have Undergone Kidney Transplantation After Imlifidase Administration.
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
Secondary outcomes:
measure: Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Patient Survival.
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Estimated Glomerular Filtration Rate (eGFR)).
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Plasma (P)-Creatinine).
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Kidney Function (Proteinuria).
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Number of Graft Rejection Episodes.
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatment of Graft Rejection Episodes.
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Comorbidities.
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Treatments of Comorbidities.
timeFrame: 5 years after first dose of imlifidase (in the feeder study). Note: concomitant immunosuppressive medication up until year 5
measure: Assessment of Safety Laboratory Testing in Terms of Hematology (Hb)
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Assessment of Safety Laboratory Testing in Terms of Hematology (Differential Analysis of Leucocytes)
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Assessment of Safety Laboratory Testing in Terms of Hematology (Thrombocytes)
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Assessment of Safety Laboratory Testing in Terms of Total Immunoglobulin G (IgG)
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Assessment of Donor Specific Antibodies (DSA)
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Assessment of the Presence of BK Virus
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Assessment of the Immunogenicity of Imlifidase
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (EQ-5D-5L).
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
measure: Evaluation of Long-term Clinical Outcomes of Transplanted Subjects Treated With Imlifidase in Terms of Quality of Life (KDQOL-SF).
timeFrame: 5 years after first dose of imlifidase (in the feeder study)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Paris
country: France
facility: Necker Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Hansa Biopharma AB
name: Clinical Operations
role: STUDY_DIRECTOR
References: