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Imlifidase with combination therapy in highly sensitized kidney transplant patients
NCT05049850Phase 2
Key facts
- Status
- Terminated
- Start
- Dec 2022
- Primary completion
- Feb 2024
- Countries
- 1
- Sponsor
- Hansa Biopharma
- Modality
- Therapeutic Enzymes
- Drugs
- imlifidase
- Conditions
- antibody mediated rejection (AMR)
01
Overview
Phase 2, open-label, single-arm trial of imlifidase in antibody mediated rejection (AMR), sponsored by Hansa Biopharma. Primary endpoint: Proportion of Patients With Donor Specific Antibodies Rebound at 3 months. Started Dec 2022; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Imlifidase + Combination Therapy
Imlifidase 0.25 mg/kg IV combined with bortezomib, belatacept, rituximab, and IVIg plus standard immunosuppression
03
Who it enrols
Highly sensitized patients (cPRA ≥98%) with chronic kidney disease and positive crossmatch towards living donor, aged 18-70 years, excluding those with HIV, active HBV/HCV/CMV/EBV infection, EBV seronegative, SARS-CoV-2 positive, prior imlifidase treatment, or severe cardiac/respiratory disease
04
Endpoints
Primary
Proportion of Patients With Donor Specific Antibodies Rebound
Secondary
Proportion of Patients With Kidney Biopsy Proven Antibody-Mediated Rejection
Proportion of Patient With Donor Specific Antibodies Rebound
Proportion of Patients With Negative Flow Cytometry Crossmatch
Levels of Donor Specific Antibodies
Levels of Complement Binding (C1q) Donor Specific Antibodies
Number of Participants With Graft Survival
Patient Survival
Number of Participants With Adverse Events
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