Personalization of Immunosuppressive Treatment for Organ Transplant Recipients (STAART)

February 22, 2024 updated by: George Washington University

Surveillance Testing Utilizing AlloSure to Assess Rejection Following Transplantation and Personalization of Immunosuppressive Therapy

Long-term graft failure rates continue to be unacceptably high despite the development of immunosuppressive drugs, underscoring the unmet need for robust prognostic biomarkers of allograft injury and failure. While rates of acute rejection (AR) continue to decrease, it remains the strongest predictor of long-term allograft survival, and so having a better understanding of factors predicting AR may contribute to more individualized patient care. Selecting optimum immunosuppressive dosage is another factor in personalizing kidney care. This project will study two areas of individualized kidney care: 1) assessing rejection by surveillance testing utilizing AlloSure, 2) developing an algorithm to select optimum immunosuppressive medication dosage.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

subjects with kidney transplants

Description

Inclusion Criteria:

  • Adult 18-80 year old
  • Kidney transplant recipients (de novo or re-transplant, from living or deceased donor)
  • BMI over 30
  • Recipients with pre formed human leukocyte antigens (HLA) antibodies
  • Recipients with donor specific antibodies
  • Recipients who have undergone blood type incompatible transplantation (ABO incompatible)
  • Recipients who have had prior kidney transplants.

Exclusion Criteria:

  • Multi-Visceral transplant (simultaneous kidney pancreas, liver kidney, heart kidney)
  • Contraindication to renal biopsy
  • Refusing biopsy
  • Kidney transplant recipient that is a monozygotic twin to the donor
  • When more than two genomes may be present in the recipient plasma (more than recipient + donor): pregnancy, multiple-organ transplants from different donors (kidney after heart, kidney after liver transplant etc.), recipients of allogeneic blood or bone marrow transplant who have received cells with a genome different from the recipient (e.g. non-monozygotic twin)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AlloSure Assay prediction of Anti-body Mediated Rejection
Determine whether AlloSure predicts the incidence of active, chronic Anti-body Mediated Rejection and cellular rejection in high risk patients
Diagnostic test: AlloSure
AlloSure blood-draw at Post-operation day one and four, as well as one month, 2 months, 3, 9, 12, 15,18 and 24 months operation.
Diagnostic test: PAXGene
1 PAXgene tube will be collected with every biopsy performed and sent with the AlloSure test for the second 100 patients (patients 101-200). 21 gene markers will be sequenced by collecting 3 ml of blood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AlloSure value change
Time Frame: post-operation day 1 and four. Pos-operation months 1, 2, 3,4,5,6
Examine if AlloSure predicts the incidence of active, chronic Active antibody mediated rejection (cAMR) and cellular rejection in high risk patients. This will be assessed through observing the changes in AlloSure values one draw after another.
post-operation day 1 and four. Pos-operation months 1, 2, 3,4,5,6
PAXGene,
Time Frame: 1 PAXgene tube will be collected 3 months post operation
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
1 PAXgene tube will be collected 3 months post operation
PAXGene
Time Frame: 1 PAXgene tube will be collected one year post operation
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
1 PAXgene tube will be collected one year post operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploring the association between Cytochrome P450 (CYP) expression and Donor-Derived Cell-Free DNA (dd-cfDNA)
Time Frame: post-operation day 1
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that AlloSure will correlate with increased CYP expression.
post-operation day 1
Exploring the association between CYP expression and dd-cfDNA
Time Frame: post-operation day 4
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
post-operation day 4
Exploring the association between CYP expression and dd-cfDNA
Time Frame: post-operation month 1
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
post-operation month 1
Exploring the association between CYP expression and dd-cfDNA
Time Frame: post-operation month 2
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
post-operation month 2
Exploring the association between CYP expression and dd-cfDNA
Time Frame: post-operation month 3
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
post-operation month 3
Exploring the association between CYP expression and dd-cfDNA
Time Frame: post-operation month 4
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
post-operation month 4
Exploring the association between CYP expression and dd-cfDNA
Time Frame: post-operation month 5
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
post-operation month 5
Exploring the association between CYP expression and dd-cfDNA
Time Frame: post-operation month 6
Determine whether there is an association between CYP expression and dd-cfDNA in high risk patients and minority African American patients. CYP expression will be assessed with each AlloSure draw. We hypothesize that Allosure will correlate with increased CYP expression.
post-operation month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Collaborators

CareDx
VirginiaBio Analytics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

December 8, 2022

Study Completion (Actual)

December 8, 2022

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCR191914

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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