Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys (ConfIdeSLTFU)

Hansa Biopharma

Status

Active, not recruiting

Conditions

Kidney Transplantation in Highly Sensitized Patients

Treatments

Other: Best available treatment administered in the ConfIdeS study

Drug: Imlifidase administered in the ConfIdeS study

Study type

Observational

Funder types

Industry

Identifiers

NCT05714514

21-HMedIdes-25

Details and patient eligibility

About

The goal of this follow-up study is to learn about long-term patient survival and graft function in highly sensitized patients who have received desensitization treatment with imlifidase or standard of care (SoC) in order to enable kidney transplantation in clinical study ConfIdeS (20-HMedIdeS-17, NCT04935177).

Full description

This is an observational follow-up study subsequent to the ConfIdeS study (20-HMedIdeS-17, NCT04935177) in highly sensitized patients who were randomized to imlifidase or SoC desensitization prior to kidney transplantation with a deceased donor graft, or, if SoC perioperative treatment has been deemed not appropriate, wait for a more immunologically compatible organ offer.

After the patients have given written informed consent to participate in the follow-up they will be included in the study and followed until 5 years after randomization in the ConfIdeS study.

Most of the assessments in this study are already part of the follow up within SoC for these patients. During the local clinic routine follow-up visits at year 2, 3 and 5 after randomization in the ConfIdeS study, information about patient survival, wait-list status, graft survival, kidney function, and health related quality of life will be evaluated.

Enrollment

64 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria