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

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

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.

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Recipients after kidney transplantation using triple immunosuppression protocol based on MMF

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2021

Primary Completion (Anticipated)

December 22, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

May 27, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • XJTU1AF2019LSK-038-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Antibody-mediated Rejection

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