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

DSA Risk Factors in Chinese Kidney Transplant Patients Using MPA-based Immunosuppression Protocol: A Multi-center Clinical Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04368962

Acronym

DRFMBIPTP

Enrollment

300

Registered

2020-04-30

Start date

2021-01-22

Completion date

2023-12-01

Last updated

2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibody-mediated Rejection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
DSA 12 month	2021.5-2023.5	newborn DSA in recipient serum in the first 12 month after transplantation

Secondary

Measure	Time frame	Description
DSA 6 month	2020.12-2022.12	newborn DSA in recipient serum in the first 6 month 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
AR	2020.5-2023.5	AMR after transplantation
allograft function	2021.5-2023.5	serum creatinine and creatinine clearance in 1 year after transplantation

Countries

China

Contacts

Primary ContactWujun Xue, Prof.

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

Backup ContactJin Zheng, Prof.

jzheng@mail.xjtu.edu.cn+86 18133916118

Outcome results