Cell-based Assays for Antibody-mediated Transplant Rejection | NCT03916822

Studies
Cell-based Assays for Antibody-mediated Transplant Rejection

NCT03916822

Sponsor

Plexision

Status

Unknown status

Last Update Posted

Sep 23, 2020Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Antibody-Mediated Graft Rejection

Interventions

Alloantigen-specific B-cells

Countries

United States

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

Sep 2020

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

Apr 15, 2019Actual

Primary Completion Date

Jun 14, 2021Estimated

Completion Date

Aug 14, 2021Estimated

First Submitted Date

Apr 12, 2019

First Submission Date that Met QC Criteria

Apr 12, 2019

First Posted Date

Apr 16, 2019Actual

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

Sep 21, 2020

Last Update Posted Date

Sep 23, 2020Actual

Name	Class
Medical University of South Carolina	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Goal: The goal of this study is to validate blood tests, which can detect antibody-mediated rejection (ABMR) after renal transplantation. These cell based assays measure CD154-expressing alloantigen-specific B-cells and their subsets in peripheral blood of adult renal transplant recipients. Thirty recipients will be enrolled at two transplant centers, 10 each with ABMR, T-cell mediated rejection (TCMR), and no rejection. Each subject will be sample twice, before and after rejection. Donor-specific anti-HLA antibodies will also be measured with single antigen beads.

Detailed Description

This cross-sectional open label study will evaluate whether alloantigen-specific B-cells and their subsets which express CD154 are associated with antibody-mediated rejection after first time renal transplantation in adult recipients.

Control groups include adult renal transplant recipients with T-cell-mediated rejection, and without rejection of any type.

Alloantigen-specific B-cells will be measured after stimulation of recipient peripheral blood leukocytes with those from corresponding donor and HLA-non-identical reference cells.

Thirty total subjects will be enrolled after IRB-approved informed consent, 15 at each of two sites. These subjects will include ten each with biopsy-proven ABMR and TCMR and ten with no rejection.

Each subject will be sampled twice, before and after treatment rejection, at intervals no less than 30 days, and not to exceed 90 days.

B-cells subsets will include those that also express cytokines, and those that are categorized as memory or naive, and their isotope switched or unswitched subsets, transitional B-cells or plasmablasts, etc.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
ABMR	Biopsy-proven ABMR-Banff criteria, with or without Complement binding donor-specific anti-HLA antibodies	Diagnostic Test: Alloantigen-specific B-cells
TCMR	Biopsy-proven TCMR-Banff 1A, 1B, 2 and 3	Diagnostic Test: Alloantigen-specific B-cells
No Rejection	Biopsy-proven, or clinical criteria	Diagnostic Test: Alloantigen-specific B-cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alloantigen-specific B-cells	Diagnostic Test	Alloantigen-specific B-cells which express CD154 and their subsets which also co-express cytokines, memory and naive markers, and additional derivatives of these markers will be measured with flow cytometry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antibody-mediated rejection	Biopsy-proven antibody-mediated rejection after primary renal transplantation	up to 90 days per subject

Secondary Outcomes

Measure	Description	Time Frame
T-cell mediated rejection (TCMR)	Biopsy-proven TCMR after primary renal transplantation	up to 90 days per subject

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

IRB-approved informed consent.
Adults (>18 yr to 70 years)
Primary renal transplant recipients with biopsy-proven ABMR, TCMR or recipients with no rejection

Exclusion Criteria:

Lack of informed consent
Concomitant BK virus infection
Vulnerable populations including children <18 yr, pregnant women, and prisoners

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Adults who have received primary renal transplants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rakesh Sindhi, MD	Contact	412-224-2507		rakesh@plexision.com
Ashok Reddy	Contact	301-651-3367		ashok.reddy@plexision.com

Overall Officials

Name	Affiliation	Role
Rakesh Sindhi, MD	Plexision	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erie County Medical Center	Not yet recruiting	Buffalo	New York	14215	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD will be retained at enrollment sites, Results of testing samples, and related de-identified data of the subject will be summarized and shared with all investigators of this study, and reported in publications

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided