An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients

Brief Summary:
The purpose of this study is 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 an active or chronic active antibody mediated rejection (AMR) after recently been kidney transplanted. The purpose is also to investigate and compare safety for these two treatments.

20 patients will be treated with imlifidase and 10 with PE.

Detailed Description:
Antibodies to HLA antigens have a strong correlation with allograft injury and loss. Treatment with imlifidase, PE and immunoabsorption (IA) all aim to reduce antibody levels.

This study will compare the reduction in DSA levels after treatment with imlifidase and PE in patients diagnosed with active or chronic active AMR (according to Banff 2017 criteria) having at least a 25% rise in serum creatinine compared with last measurement prior to the AMR (Patients with delayed graft function and AMR within 10 days after kidney transplantation can be included regardless of serum creatinine level).

Included patients will be randomized to receive either 1 dose of imlifidase (0.25 mg/kg) or 5-10 sessions of PEs (IA may replace PE at the discretion of the investigator). All patients will receive pulse methylprednisolone for 3 days, starting before the 1st treatment, followed by a tapering schedule with prednisolone/prednisone. The patients will also receive high dose IVIg 3 days after imlifidase treatment or directly after the last PE. In addition a single dose of rituximab will be given 5 days after completed IVIg infusion.


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: April 30, 2019
Estimated Primary Completion Date: June 2021
Estimated Study Completion Date: December 2021

Arm:
- Experimental: Imlifidase
- Active Comparator: Plasma Exchange

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