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

Hansa Biopharma

Status: Completed

Conditions: Kidney Transplant Failure and Rejection

Treatments: Drug: Imlifidase

Study type: Observational

Funder types: Industry

Identifiers

NCT03611621

17-HMedIdeS-14

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design