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

Antibody-mediated Rejection Clinical Trial

— DRFMBIPTP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368962
• Other study ID #: XJTU1AF2019LSK-038-1
• Status: Recruiting
• Start date: January 22, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2021
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Wujun Xue, Prof.
• Phone: +86 13991990128
• Email: xwujun163[@]mail.xjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2023
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibody-mediated Rejection

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View 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. — View Citation

Miettinen J, Peräsaari 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/s00467-011-2007-6. Epub 2011 Oct 13. — View 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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DSA 12 month	newborn DSA in recipient serum in the first 12 month after transplantation	2021.5-2023.5
Secondary	DSA 6 month	newborn DSA in recipient serum in the first 6 month after transplantation	2020.12-2022.12
Secondary	DSA risk factors	risk factors of newborn DSA	2020.5-2023.5
Secondary	MPA-AUC	trough concentration of MMF in recipients' serum	2020.5-2023.5
Secondary	AR	AMR after transplantation	2020.5-2023.5
Secondary	allograft function	serum creatinine and creatinine clearance in 1 year after transplantation	2021.5-2023.5