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

NCT06453135 | Not Yet Recruiting Phase 1

• 1 other identifier: WestChina-ECU-KT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Transplantation

Keywords

Kidney Transplantation; Eculizumab; Antibody-mediated rejection

Outcome Measures

Primary Outcomes (1)

• The incidence of AMR within 6 months after transplantation

  6 months after kidney transplant surgery

Study Arms (1)

Eculizumab

EXPERIMENTAL

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

Drug: Eculizumab

Interventions

Eculizumab DRUG

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.

Also known as: Soliris

Eculizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged ≥ 18 years, male or female
• Suffering from end-stage renal disease and planning for ABO blood group incompatible living donor kidney transplantation
• Vaccinated against Neisseria meningitides (quadrivalent vaccine), Pneumococcus or H. influenzae at least two weeks prior to using eculizumab
• Be able to understand the informed consent form and willing to comply with the protocol

You may not qualify if:

• Previous splenectomy
• Any active bacterial or other infection
• Known or suspected hereditary complement deficiency
• Known hypersensitivity to the treatment drug or any of its excipients
• History of Neisseria meningitidis
• 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)

Sponsors & Collaborators

• Tao Lin: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

eculizumab

Central Study Contacts

Tao Lin, M.D.

CONTACT

18980602093; dr_taolin@163.com

Hao Zhang, M.D.

CONTACT

13228207256; zhanghaoscu@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator (PI)

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)