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Clinical trial

A Single Center, Open-label, Single-arm Study to Determine the Safety and Efficacy of a Single Dosing Regimen Eculizumab for Prevention of Antibody-Mediated Rejection (AMR) in ABO Blood Group Incompatible Living Donor Kidney Transplantation (ABOi-LDKTx)

ID
Name
WestChina-ECU-KT
Description
The aim of this study is to determine whether a single dose of eculizumab can effectively prevent antibody-mediated rejection in recipients undergoing living donor kidney transplantation with a different ABO blood group type than their donors
Trial arms
Trial start
2024-07-01
Estimated PCD
2025-07-01
Trial end
2025-12-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
Eculizumab
On the Day 0, participants received a single dose of eculizumab before the transplant surgery: 900 mg (blood type antibody titer ≥ 1devel:64 and/or body weight ≥ 60 kg) or 600 mg (blood type antibody titer \< 1:64 and body weight \< 60 kg). Plasmapheresis was not planned. When participants developed AMR, they may receive additional dose of eculizumab.
Arms:
Eculizumab
Other names:
Soliris
Size
30
Primary endpoint
The incidence of AMR within 6 months after transplantation
6 months after kidney transplant surgery
Eligibility criteria
Inclusion Criteria: 1. aged ≥ 18 years, male or female 2. Suffering from end-stage renal disease and planning for ABO blood group incompatible living donor kidney transplantation 3. Vaccinated against Neisseria meningitides (quadrivalent vaccine), Pneumococcus or H. influenzae at least two weeks prior to using eculizumab 4. Be able to understand the informed consent form and willing to comply with the protocol Exclusion Criteria: 1. Previous splenectomy 2. Any active bacterial or other infection 3. Known or suspected hereditary complement deficiency 4. Known hypersensitivity to the treatment drug or any of its excipients 5. History of Neisseria meningitidis 6. Any health condition that the investigator believes may interfere with the patient's participation, pose additional risks to the patient, or confound with the patient's assessment (e.g. severe cardiovascular or pulmonary disease)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-06-11

1 organization

1 product

1 indication

Organization
Tao Lin
Product
Eculizumab
Indication
Kidney Transplant