A Randomized, Open-Label, Multi-Centre, Active Control, Efficacy and Safety Study of Imlifidase in Eliminating Donor Specific Anti-HLA Antibodies in the Treatment of Active Antibody-Mediated Rejection in Kidney Transplant Patients

16-HMedIdeS-12

The purpose of this study was to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have had an active or chronic active antibody mediated rejection (AMR) after being kidney transplanted. The purpose was also to investigate and compare safety for these two treatments.

2019-04-30

2022-05-28

2022-11-16

Completed

Early phase I

30

Inclusion Criteria: 1. Signed Informed Consent obtained before any study-related procedures 2. Willingness and ability to comply with the protocol 3. Male and/or female donor kidney recipients age ≥18 years at the time of screening 4. Presence of DSA(s) 5. Meet the Banff 2017 criteria for active or chronic active AMR 6. At least 25% rise in serum creatinine compared to last individual value taken prior to the AMR. Patients with delayed graft function and AMR within 10 days after transplant (confirmed by kidney biopsy) can be included regardless of serum creatinine level 7. Women of child-bearing potential willing or able to use at least one highly effective contraceptive method throughout the study. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly 8. Men willing to use double-barrier contraception from the first day of treatment until at least 2 months after the dose of imlifidase, if not abstinent Exclusion Criteria: 1. Previous treatment with imlifidase 2. Previous high dose IVIg treatment (2 g/kg) within 28 days prior to inclusion 3. Lactating or pregnant females 4. Significantly abnormal general serum screening lab results judged inappropriate for inclusion in the study by the investigator 5. Intake of other investigational drugs within 5 half-lives (or similar) of the product prior to inclusion 6. Clinically relevant active infection(s) as judged by the investigator 7. Any condition that in the opinion of the investigator could increase the subject's risk by participating in the study such as severe immune deficiency and severe cardiac insufficiency \[New York Heart Association (NYHA) Class IV\] or severe uncontrolled heart disease 8. Known allergy/sensitivity to imlifidase, IVIg and/or rituximab and the respective excipients 9. Patient unable to tolerate treatment with plasmapheresis or immunoadsorption, as judged by the investigator 10. Unsuitable to participate in the study for any other reason as judged by the investigator 11. Positive polymerase chain reaction (PCR) test for severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection 12. Current diagnosis or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2024-02-28