Eculizumab for Prevention of Antibody-Mediated Rejection in ABO-Incompatible Living Donor Kidney Transplantation

Tao Lin

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Kidney Transplantation

Treatments: Drug: Eculizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06453135

WestChina-ECU-KT

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Eculizumab

Experimental group

Description:

A single dose of eculizumab was given on the Day 0 before the transplant surgery.

Treatment:

Drug: Eculizumab