NCT06453135

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

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)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tao Lin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Eculizumab	On the Day 0, participants received a single dose of eculizumab before the transplant surgery: 900 mg (blood type antibody titer ≥ 1:64 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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-07-01
• Completion: 2025-12-01
• First posted: 2024-06-11
• Last updated: 2024-06-13

Locations

1 site across 1 country: China