organ transplantation
Conditions
Interventions
KJ103 Treatment Group:0.25 mg/kg KJ103
Sponsors
Huazhong University of Science & Technology/ Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Male or female participants aged 18-65 years (inclusive). 2) Patients on the kidney transplant waiting list who had previously failed desensitisation or had a minimal chance of successful desensitisation. 3) Screening criteria: Panel reactive antibody (PRA) =80% or donor specific antibody (DSA) mean fluorescence intensity (MFI) =8000. 4) ABO blood group compatible kidney transplant recipients (applicable to Phase III studies only). 5) Patients able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Received KJ103 or similar products such as imlifidase treatment within the last year. 2) Received high-dose IVIG (2 g/kg BW) within 28 days prior to dosing. 3) Breastfeeding, pregnant, planning to become pregnant during the study period or within 6 months after the study period without effective contraception (see Appendix 1). 4) HIV positive patients. 5) Patients with active HBV or HCV. 6) Patients with CMV or EBV infection (unless considered by the investigator not to interfere with study participation). 7) Patients with active pulmonary tuberculosis. 8) Patients with clinically significant abnormal laboratory test results (unless considered by the investigator not to interfere with study participation). 9) Haemoglobin (Hb) 3), unstable coronary artery disease, or chronic obstructive pulmonary disease (COPD). 11) Patients who are unable to comply with the study protocol. 12) Patients with a significant history of thrombotic disease, active peripheral vascular disease, or diagnosed hypercoagulable state. 13) Current malignancy or history of malignancy within the last 5 years, except for squamous or basal cell carcinoma that has been excised or removed by procedures such as scraping or electrodessication. 14) Received any other investigational product (or device) within 28 days prior to screening or within at least 5 half-lives (whichever is longer). 15) History of significant allergy to KJ103 components or related products (including formulation excipients) or severe allergic reaction to any drug (e.g. angioedema). 16) Karnofsky Performance Status (KPS) score <70 (see Appendix 2). 17) Any other condition that the investigator considers unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the efficacy of KJ103 to reduce pre-existing DSA levels to transplant acceptable negative levels within 24 hours post-KJ103 administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Changes in PRA and DSA levels post-KJ103 administration compared to baseline.;Pharmacokinetic (PK) parameters;Pharmacodynamics (PD) ;Immunogenicity;kidney function; | — |
Countries
China
Contacts
Public ContactZhishui Chen
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Outcome results
None listed