DSA Risk Factors in MMF-based Immunosuppressed Post-trans... | NCT04368962

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

NCT04368962

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Status

Unknown status

Last Update Posted

May 27, 2022Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Antibody-mediated Rejection

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2021Actual

Primary Completion Date

Dec 22, 2022Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Apr 27, 2020

First Submission Date that Met QC Criteria

Apr 27, 2020

First Posted Date

Apr 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2022

Last Update Posted Date

May 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MMF group		Post-transplant patients accept immunosuppression protocol based on MMF for at least 12 months.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
DSA 12 month	newborn DSA in recipient serum in the first 12 month after transplantation	2021.5-2023.5

Secondary Outcomes

Measure	Description	Time Frame
DSA 6 month	newborn DSA in recipient serum in the first 6 month after transplantation	2020.12-2022.12
DSA risk factors	risk factors of newborn DSA

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Recipients after kidney transplantation using triple immunosuppression protocol based on MMF

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Wujun Xue, Prof.	Contact	+86 13991990128		xwujun163@mail.xjtu.edu.cn
Jin Zheng, Prof.	Contact	+86 18133916118		jzheng@mail.xjtu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital of Xi'an Jiaotong University	Recruiting	Xi'an	Shaanxi	710061	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25545626	Background	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.
21993970	Background	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.