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

Kidney Transplantation Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06453135
• Other study ID #: WestChina-ECU-KT
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: July 2024
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: West China Hospital
• Contact: Tao Lin, M.D.
• Phone: 18980602093
• Email: dr_taolin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

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.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Tao Lin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of AMR within 6 months after transplantation		6 months after kidney transplant surgery