- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04368962
DSA Risk Factors in MMF-based Immunosuppressed Post-transplanted Patients (DRFMBIPTP)
May 25, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University
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
Conditions
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
- Name: Wujun Xue, Prof.
- Phone Number: +86 13991990128
- Email: xwujun163@mail.xjtu.edu.cn
Study Contact Backup
- Name: Jin Zheng, Prof.
- Phone Number: +86 18133916118
- Email: jzheng@mail.xjtu.edu.cn
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Contact:
- Jin Zheng, Dr.
- Phone Number: 86-18133916118
- Email: jzheng@xjtu.edu.cn
-
-
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
- Meier-Kriesche HU, Schold JD, Srinivas TR, Kaplan B. Lack of improvement in renal allograft survival despite a marked decrease in acute rejection rates over the most recent era. Am J Transplant. 2004 Mar;4(3):378-83. doi: 10.1111/j.1600-6143.2004.00332.x.
- Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30. doi: 10.1056/NEJM199912023412303.
- Huang J, Millis JM, Mao Y, Millis MA, Sang X, Zhong S. Voluntary organ donation system adapted to Chinese cultural values and social reality. Liver Transpl. 2015 Apr;21(4):419-22. doi: 10.1002/lt.24069. Epub 2015 Feb 13.
- Miettinen J, Perasaari J, Lauronen J, Qvist E, Valta H, Pakarinen M, Merenmies J, Jalanko H. Donor-specific HLA antibodies and graft function in children after renal transplantation. Pediatr Nephrol. 2012 Jun;27(6):1011-9. doi: 10.1007/s00467-012-2101-4. Epub 2011 Oct 13.
- Ginevri F, Nocera A, Comoli P, Innocente A, Cioni M, Parodi A, Fontana I, Magnasco A, Nocco A, Tagliamacco A, Sementa A, Ceriolo P, Ghio L, Zecca M, Cardillo M, Garibotto G, Ghiggeri GM, Poli F. Posttransplant de novo donor-specific hla antibodies identify pediatric kidney recipients at risk for late antibody-mediated rejection. Am J Transplant. 2012 Dec;12(12):3355-62. doi: 10.1111/j.1600-6143.2012.04251.x. Epub 2012 Sep 7.
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
-
Brigham and Women's HospitalAlexion PharmaceuticalsTerminatedAntibody-mediated Rejection | Humoral RejectionUnited States
-
Shahid Beheshti University of Medical SciencesRecruitingAntibody-mediated RejectionIran, Islamic Republic of
-
University Hospital, MontpellierInstitut National de la Santé Et de la Recherche Médicale, FranceCompletedAntibody-mediated RejectionFrance
-
Farsad EskandaryCharite University, Berlin, Germany; University of Alberta; HI-BioActive, not recruiting
-
CSL BehringTerminatedAntibody-mediated RejectionUnited States, Spain, France, Netherlands, United Kingdom, Belgium, Germany
-
Medical University of ViennaCharite University, Berlin, Germany; University of Alberta; CSL BehringCompleted
-
University of ManitobaTerminatedAntibody Mediated RejectionCanada
-
Thomas MuellerUnknownAntibody-mediated Rejection
-
Medical University of ViennaRecruitingLung Transplant Rejection | Antibody-mediated RejectionAustria
-
Duke UniversityBristol-Myers SquibbWithdrawnLung Transplant Rejection | Antibody-mediated Rejection