AlloSure for the Monitoring of Antibody Mediated Processes After Kidney Transplantation
NCT ID: NCT04057742
Last Updated: 2024-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
52 participants
OBSERVATIONAL
2019-10-07
2024-04-07
Brief Summary
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* 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
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Detailed Description
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The AlloSure assay will be combined with the AlloMAP assay (PAXgene blood sample); which is the first in history FDA-cleared genomic solid organ transplantation rejection blood test (AlloMap). Immune cell phenotypes and inflammatory cytokines will be examined. The combination of the three assays will provide a comprehensive molecular diagnostic and prognostic approach to antibody-mediated processes after renal transplantation. Additionally, formalin fixed paraffin embedded (FFPE) samples from kidney biopsies for subjects in all groups will be used to validate the nCounter platform. 3 slides from each biopsy will be sent to CareDx to be examined on the nCounter system. Other routine clinical data will be examined and assessed for correlation with the nCounter results. This will include AlloSure, Molecular Microscope, eGFR, creatinine, DSA as well as other key data fields taken from the Electronic Medical Record (EMR).
AlloMap Kidney is a lab-developed test and will be provided by CareDx, Inc. located at Brisbane, CA, and is designed, manufactured and used within a single CareDx laboratory. AlloMap Kidney is currently provided as "For Research use only" test and results are not intended for clinical diagnosis or patient management for "KidneyCare", which is the AlloSure-Kidney and AlloMap-Kidney tests combined.
* Group A. Thirty participants with a positive 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, 3M (SOC biopsy), 6M, 12M (SOC biopsy) and additionally at the time of any indication biopsy (5-7 time points/patient). Subjects in this group 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 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).
* Group C. 15 additional participants with the diagnosis of 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 3M (follow-up surveillance biopsy) (2 timepoints/patient). Participants in this group will be monitored per SOC for three months (time between the two biopsies).
For all three groups, history and physical, blood draws and urine sample collections are performed per SOC. The only addition is blood sample collection and additional urine collection at the indicated SOC timepoints for AlloSure, AlloMap, immune cell flow cytometry, RNA-signatures, and inflammatory cytokines. In addition, leftover pathology slides that are stored in the pathology department will be sent out to CareDx for the purposes of performing the NanoString analysis. The slides will be returned to the pathology department after the NanoString analysis is complete.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
AlloSure ddcfDNA assay
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
AlloMap assay
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
Inflammatory Cytokines
10 mL collection at transplant, 3 weeks, 6 weeks, 6 months, 12 months post-transplant for Group A
Immune Cell Phenotypes
Collection of up to 1 cup of urine for per participant each study visit
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).
AlloSure ddcfDNA assay
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
AlloMap assay
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
Immune Cell Phenotypes
Collection of up to 1 cup of urine for per participant each study visit
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).
AlloSure ddcfDNA assay
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
AlloMap assay
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
Immune Cell Phenotypes
Collection of up to 1 cup of urine for per participant each study visit
Interventions
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AlloSure ddcfDNA assay
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
AlloMap assay
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
Inflammatory Cytokines
10 mL collection at transplant, 3 weeks, 6 weeks, 6 months, 12 months post-transplant for Group A
Immune Cell Phenotypes
Collection of up to 1 cup of urine for per participant each study visit
Eligibility Criteria
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Inclusion Criteria
* Positive Virtual Crossmatch at transplant (Group A)
* Undergoing SOC biopsy for dnDSA (Group B)
* Proven cAMR (Group C)
Exclusion Criteria
* Contraindication to renal biopsy
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
CareDx
INDUSTRY
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Sarah Panzer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Wisconsin - Madison
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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Banff Foundation for Allograft Pathology
Other Identifiers
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A534280
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/MEDICINE/MEDICINE*N
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 3/13/2023
Identifier Type: OTHER
Identifier Source: secondary_id
2019-0750
Identifier Type: -
Identifier Source: org_study_id
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