DSA Risk Factors in MMF-based Immunosuppressed Post-transplanted Patients (DRFMBIPTP)

Xi'an Jiaotong University

Status: Unknown

Conditions: Antibody-mediated Rejection

Study type: Observational

Funder types: Other

Identifiers

NCT04368962

XJTU1AF2019LSK-038-1

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

MMF group

Description:

Post-transplant patients accept immunosuppression protocol based on MMF for at least 12 months.