NCT04057742

Brief Summary

This is a prospective cohort observational study to assess the role of AlloSure Donor Derived Cell Free DNA (ddcfDNA) assay in the monitoring of three high-risk groups of kidney transplant patients for antibody mediated processes.

  • Group A. Thirty participants with a positive Virtual Cross-Match (VXM) at the time of transplant will be monitored for 12 months
  • Group B. Similarly, 24 participants with dnDSA will undergo a SOC biopsy within approximately three months to determine the incidence of Active Antibody Mediated Rejection (AMR)
  • Group C. 15 additional participants with the diagnosis of Chronic Active Antibody Mediated Rejection (cAMR) will undergo standard of care therapy and be monitored for treatment response with a follow-up biopsy at three months

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 7, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

4.5 years

First QC Date

August 13, 2019

Last Update Submit

August 28, 2024

Conditions

Kidney Transplant Failure and Rejection

Keywords

Chronic Active Antibody Mediated RejectioncAMR

Outcome Measures

Primary Outcomes (1)

  • Incidence of Biopsy Confirmed AMR

    To determine whether AlloSure, immune cell phenotypes, and inflammatory cytokines predict the incidence of AMR, the outcome measure will be incidence of biopsy confirmed AMR. For participants with a positive virtual crossmatch (group A), protocol biopsies are performed at 3 and 12 months posttransplant. For participants with De novo donor specific antibodies (dnDSA) (group B), protocol biopsies are performed within 3 months.

    up to 12 months post-transplant

Secondary Outcomes (7)

  • Banff Pathology

    up to 3 months following initial diagnosis of cAMR

  • Renal Allograft Function: Concentration of Serum Creatinine (sCr)

    up to 3 months following initial diagnosis of cAMR

  • Renal Allograft Function: Estimated Glomerular Filtration Rate (eGFR)

    up to 3 months following initial diagnosis of cAMR

  • Renal Allograft Function: Urinary Protein to Creatinine Ratio (UPC)

    up to 3 months following initial diagnosis of cAMR

  • Percent of Biopsy Samples Measured on Nanostring nCounter That Validate Clinical Outcomes

    experiment performed within 7 days of receiving sample

  • +2 more secondary outcomes

Study Arms (3)

Group A

30 participants with a positive virtual crossmatch (VXM) at the time of transplant will be monitored for 12 months and undergo protocol biopsies on months 3 and 12 to detect subclinical rejection. Participants may also undergo clinically indicated biopsies for suspicion of rejection. AlloSure, AlloMap, immune cell phenotypes, and inflammatory cytokines will be measured at baseline (within 48 hours of transplant), 3 weeks, 6 weeks, 3 months (Standard of Care (SOC) biopsy), 6 months, 12 months (SOC biopsy), and additionally at the time of any indication biopsy (5-7 time points/participant). Participants in this group will be monitored for 12 months. Participants will be offered the option of donating either 22.5 mL of blood (Allosure+AlloMap+cytokines) or 52.5 mL of blood (Allosure+AlloMap+cytokines+immune cell phenotyping) at each visit. Participants may change their donation volume from 22.5 mL to 52.5 mL at any point during the study.

Diagnostic Test: AlloSure ddcfDNA assayDiagnostic Test: AlloMap assayDiagnostic Test: Inflammatory CytokinesDiagnostic Test: Immune Cell Phenotypes

Group B

24 participants with De novo donor specific antibodies (dnDSA) will undergo a SOC biopsy within approximately three months to determine the incidence of Active Antibody Mediated Rejection (AMR). Immune cell phenotyping, AlloSure, and AlloMap will be measured at the time of the SOC biopsy (1 timepoint/patient). This is a single-time point study, unless participants are diagnosed with AMR and require treatment. In this case, they would be enrolled in group C (see below).

Diagnostic Test: AlloSure ddcfDNA assayDiagnostic Test: AlloMap assayDiagnostic Test: Immune Cell Phenotypes

Group C

15 additional participants with the diagnosis of Chronic Active Antibody Mediated Rejection (cAMR) will undergo standard of care therapy and be monitored for treatment response with a follow-up biopsy at three months. Immune cell phenotyping, AlloSure, and AlloMap will be used at baseline (prior to index biopsy) and 3 month (follow-up surveillance biopsy) (2 timepoints/participant). Participants in this group will be monitored per SOC for three months (time between the two biopsies).

Diagnostic Test: AlloSure ddcfDNA assayDiagnostic Test: AlloMap assayDiagnostic Test: Immune Cell Phenotypes

Interventions

AlloSure ddcfDNA assayDIAGNOSTIC_TEST

2.5 mL collection for Donor Derived Cell Free DNA at transplant, 3 weeks, 6 weeks, 6 months, 12 months post-transplant for Group A, at transplant for Group B, and transplant and 3 months for Group C

Group AGroup BGroup C
AlloMap assayDIAGNOSTIC_TEST

10 mL collection PAXgene blood sample at transplant, 3 weeks, 6 weeks, 6 months, 12 months post-transplant for Group A, at transplant for Group B, and transplant and 3 months for Group C

Group AGroup BGroup C
Inflammatory CytokinesDIAGNOSTIC_TEST

10 mL collection at transplant, 3 weeks, 6 weeks, 6 months, 12 months post-transplant for Group A

Group A
Immune Cell PhenotypesDIAGNOSTIC_TEST

Collection of up to 1 cup of urine for per participant each study visit

Group AGroup BGroup C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney Transplant Recipients

You may qualify if:

  • Kidney transplant recipients (de novo or retransplant)
  • Positive Virtual Crossmatch at transplant (Group A)
  • Undergoing SOC biopsy for dnDSA (Group B)
  • Proven cAMR (Group C)

You may not qualify if:

  • Multi-Visceral transplant
  • Contraindication to renal biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participants have the option of banking blood and urine for the purpose of measuring inflammatory cytokines.

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Study Officials

  • Sarah Panzer, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 13, 2019

First Posted

August 15, 2019

Study Start

October 7, 2019

Primary Completion

April 7, 2024

Study Completion

April 7, 2024

Last Updated

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)