Clinical trial NCT06453135: Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Kidney Transplantation
Keywords: Kidney Transplantation
Eculizumab
Antibody-mediated rejection
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: Kidney transplantation is considered the best therapy for patients with end-stage renal disease. ABO-incompatible living donor kidney transplantation (ABOi-LDKTx) is one of the strategies to expand the pool of donors. However, the blood group antibodies in recipients can lead to acute rejection, resulting in transplant failure. Before transplantation, the use of rituximab (RTX) to remove B cells; plasmapheresis to eliminate blood group antibodies can mitigate the occurrence of acute rejection and enhance the success rate of transplantation.

The complement system plays a vital role in antibody-mediated rejection (AMR). Eculizumab can target the C5 protein of the complement system and then block the activation. Therefore, we hypothesize that the pretransplant use of eculizumab may prevent the AMR in ABOi-LDKTx.

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)

Primary outcomes:
measure: The incidence of AMR within 6 months after transplantation
timeFrame: 6 months after kidney transplant surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References: