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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04368962
Recruitment Status : Not yet recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Information provided by (Responsible Party):
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.

Condition or disease
Antibody-mediated Rejection

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DSA Risk Factors in Chinese Kidney Transplant Patients Using MPA-based Immunosuppression Protocol: A Multi-center Clinical Study
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2023

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

Primary Outcome Measures :
  1. DSA 12 month [ Time Frame: 2021.5-2023.5 ]
    newborn DSA in recipient serum in the first 12 month after transplantation

Secondary Outcome Measures :
  1. DSA 6 month [ Time Frame: 2020.12-2022.12 ]
    newborn DSA in recipient serum in the first 6 month after transplantation

  2. DSA risk factors [ Time Frame: 2020.5-2023.5 ]
    risk factors of newborn DSA

  3. MPA-AUC [ Time Frame: 2020.5-2023.5 ]
    trough concentration of MMF in recipients' serum

  4. AR [ Time Frame: 2020.5-2023.5 ]
    AMR after transplantation

  5. allograft function [ Time Frame: 2021.5-2023.5 ]
    serum creatinine and creatinine clearance in 1 year after transplantation

Biospecimen Retention:   Samples Without DNA
blood sample to dectect MMF trough concentration

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Recipients after kidney transplantation using triple immunosuppression protocol based on MMF

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04368962

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Contact: Wujun Xue, Prof. +86 13991990128
Contact: Jin Zheng, Prof. +86 18133916118

Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Publications of Results:
Other Publications:
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University Identifier: NCT04368962    
Other Study ID Numbers: XJTU1AF2019LSK-038-1
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No