UnknownNot Applicable

DSA Risk Factors in MMF-based Immunosuppressed Post-transplanted Patients

China300 participantsStarted 2021-01-22

Plain-language summary

Kidney transplantation is the best therapy method for patients with uremia. The main factors affecting the long-term survival of the graft were chronic antibody-mediated rejection and the death of the patients. Newborn donor special antibody (DSA) is a major risk factor for chronic antibody-mediated rejection (AMR) and poor transplantation outcomes. Detection of mycophenolate mofetil (MMF) trough concentration can help estimate its exposure. Deficient exposure of MMF can lead to AMR after transplantation surgery. The aim of this study is to estimate the risk factors of one-year DSA after transplantation.

Who can participate

Age range

18 Years – 65 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: * years 18-65 * single organ transplantation * first time to accept kidney transplantation * Triple immunosuppression protocol based on MMF, tacrolimus and glucocorticoid * PRA negative before transplantation * not pregnant for female Exclusion Criteria: * Not accept MMF * multi-organ transplantation * pregnancy or lactation period female * mental illness * past tumor, peptic ulcer, severe cardiopulmonary disease, active liver disease history * Cannot regular follow up

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

DSA 12 month

Timeframe: 2021.5-2023.5

Trial details

NCT IDNCT04368962

SponsorFirst Affiliated Hospital Xi'an Jiaotong University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-22

Contact for this trial

Wujun Xue, Prof.

+86 13991990128 xwujun163@mail.xjtu.edu.cn

View on ClinicalTrials.gov More Antibody-mediated Rejection trials