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

NCT ID: NCT04368962

Last Updated: 2022-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-22

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Antibody-mediated Rejection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MMF group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wujun Xue, Prof.

Role: CONTACT

+86 13991990128

Jin Zheng, Prof.

Role: CONTACT

+86 18133916118

Facility Contacts

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Jin Zheng, Dr.

Role: primary

86-18133916118

References

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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.

Reference Type BACKGROUND
PMID: 25545626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21993970 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14961990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22959074 (View on PubMed)

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.

Reference Type RESULT
PMID: 10580071 (View on PubMed)

Other Identifiers

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XJTU1AF2019LSK-038-1

Identifier Type: -

Identifier Source: org_study_id

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