Clinical trial NCT04368962: DSA Risk Factors in MMF-based Immunosuppressed Post-transplanted Patients
Official title: DSA Risk Factors in Chinese Kidney Transplant Patients Using MPA-based Immunosuppression Protocol: A Multi-center Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibody-mediated Rejection
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recipients after kidney transplantation using triple immunosuppression protocol based on MMF

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.


Eligibility criteria: 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

Primary outcomes:
measure: DSA 12 month
timeFrame: 2021.5-2023.5
Secondary outcomes:
measure: DSA 6 month
timeFrame: 2020.12-2022.12
measure: DSA risk factors
timeFrame: 2020.5-2023.5
measure: MPA-AUC
timeFrame: 2020.5-2023.5
measure: AR
timeFrame: 2020.5-2023.5
measure: allograft function
timeFrame: 2021.5-2023.5
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.