NCT04368962

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

January 22, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 27, 2022

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

April 27, 2020

Last Update Submit

May 25, 2022

Conditions

Antibody-mediated Rejection

Outcome Measures

Primary Outcomes (1)

  • DSA 12 month

    newborn DSA in recipient serum in the first 12 month after transplantation

    2021.5-2023.5

Secondary Outcomes (5)

  • DSA 6 month

    2020.12-2022.12

  • DSA risk factors

    2020.5-2023.5

  • MPA-AUC

    2020.5-2023.5

  • AR

    2020.5-2023.5

  • allograft function

    2021.5-2023.5

Study Arms (1)

MMF group

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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Recipients after kidney transplantation using triple immunosuppression protocol based on MMF

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 25545626BACKGROUND

  • 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.

    PMID: 21993970BACKGROUND

  • 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.

    PMID: 14961990BACKGROUND

  • 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.

    PMID: 22959074BACKGROUND

  • 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.

    PMID: 10580071RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample to dectect MMF trough concentration

Central Study Contacts

Wujun Xue, Prof.

CONTACT

+86 13991990128xwujun163@mail.xjtu.edu.cn

Jin Zheng, Prof.

CONTACT

+86 18133916118jzheng@mail.xjtu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2020

First Posted

April 30, 2020

Study Start

January 22, 2021

Primary Completion

December 22, 2022

Study Completion

December 1, 2023

Last Updated

May 27, 2022

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)