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

• Conditions: Antibody-mediated Rejection

• Registration Number: NCT04368962
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-30
• Study Start: 2021-01-22
• Status Verified: 2021-08
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-27
• Primary Completion: 2022-12-22
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DSA 12 month	2021.5-2023.5	newborn DSA in recipient serum in the first 12 month after transplantation

Secondary Outcome Measures

Name	Time	Method
AR	2020.5-2023.5	AMR after transplantation
DSA risk factors	2020.5-2023.5	risk factors of newborn DSA
MPA-AUC	2020.5-2023.5	trough concentration of MMF in recipients' serum
allograft function	2021.5-2023.5	serum creatinine and creatinine clearance in 1 year after transplantation
DSA 6 month	2020.12-2022.12	newborn DSA in recipient serum in the first 6 month after transplantation

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China