A Randomized Open-Label Multi-Centre Active Control Study Investigating the Efficacy and Safety of Imlifidase in Eliminating Donor Specific Anti-HLA Antibodies in the Treatment of Active Antibody-Mediated Rejection in Kidney Transplant Patients
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
-
Conditions: Antibody Mediated RejectionEnd Stage Renal Disease
-
Age: Between 18 years - 99 years
-
Gender: Male or Female
-
Other Inclusion Criteria:
- Subjects who are donor kidney recipients
- Subjects should have the presence of donor specific antibodies (DSA(s))
- Subjects who are undergoing active Antibody Mediated Rejection (AMR)
- Subjects who have blood test results of at least 25% rise in serum creatinine compared to last individual value taken prior to the AMR.
You may not be eligible for this study if the following are true:
-
- Subjects with previous treatment with imlifidase
- Subjects who underwent previous high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion
- Subjects with significantly abnormal general serum screening lab results judged inappropriate for inclusion in the study by the investigator
- Subjects who have taken other investigational drugs
- Subjects who have clinical relevant active infections
- Subjects who have known allergy/sensitivity to imlifidase, IVIg and/or rituximab and the respective excipients
- Subjects who are unable to tolerate treatment with plasmapheresis or immunoadsorption, as judged by the investigator
- Subjects who are unsuitable to participate in the study for any other reason as judged by the investigator
- Subjects with any condition that in the opinion of the investigator could increase the subject’s risk by participating in the study
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.