Not Yet RecruitingPhase 1/2

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

China30 participantsStarted 2024-07

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The incidence of AMR within 6 months after transplantation

Timeframe: 6 months after kidney transplant surgery

Trial details

NCT IDNCT06453135

SponsorTao Lin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07

Contact for this trial

Tao Lin, M.D.

18980602093 dr_taolin@163.com

View on ClinicalTrials.gov More Kidney Transplantation trials