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Personalization of Immunosuppressive Treatment for Organ Transplant Recipients (STAART)

Primary Purpose

Kidney Injury, Kidney Failure, Kidney Failure, Chronic

Status
Suspended
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AlloSure
PAXGene
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • George Washington University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AlloSure Assay prediction of Anti-body Mediated Rejection

Arm Description

Determine whether AlloSure predicts the incidence of active, chronic Anti-body Mediated Rejection and cellular rejection in high risk patients

Outcomes

Primary Outcome Measures

AlloSure value change
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.
PAXGene,
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
PAXGene
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.

Secondary Outcome Measures

Exploring the association between Cytochrome P450 (CYP) expression and Donor-Derived Cell-Free DNA (dd-cfDNA)
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.
Exploring the association between CYP expression and dd-cfDNA
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.
Exploring the association between CYP expression and dd-cfDNA
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.
Exploring the association between CYP expression and dd-cfDNA
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.
Exploring the association between CYP expression and dd-cfDNA
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.
Exploring the association between CYP expression and dd-cfDNA
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.
Exploring the association between CYP expression and dd-cfDNA
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.
Exploring the association between CYP expression and dd-cfDNA
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.

Full Information

First Posted
January 27, 2023
Last Updated
February 16, 2023
Sponsor
George Washington University
Collaborators
CareDx, VirginiaBio Analytics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05747053
Brief Title
Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Acronym
STAART
Official Title
Surveillance Testing Utilizing AlloSure to Assess Rejection Following Transplantation and Personalization of Immunosuppressive Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
will resume after internal review
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
Collaborators
CareDx, VirginiaBio Analytics, LLC

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Injury, Kidney Failure, Kidney Failure, Chronic, Kidney Failure, Acute, Kidney Diseases, Kidney Transplant Rejection, Kidney Transplant Infection, Kidney Transplant; Complications, Kidney Disease, Chronic, Kidney Ischemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AlloSure Assay prediction of Anti-body Mediated Rejection
Arm Type
Experimental
Arm Description
Determine whether AlloSure predicts the incidence of active, chronic Anti-body Mediated Rejection and cellular rejection in high risk patients
Intervention Type
Diagnostic Test
Intervention Name(s)
AlloSure
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
PAXGene
Intervention Description
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.
Primary Outcome Measure Information:
Title
AlloSure value change
Description
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.
Time Frame
post-operation day 1 and four. Pos-operation months 1, 2, 3,4,5,6
Title
PAXGene,
Description
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
Time Frame
1 PAXgene tube will be collected 3 months post operation
Title
PAXGene
Description
The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
Time Frame
1 PAXgene tube will be collected one year post operation
Secondary Outcome Measure Information:
Title
Exploring the association between Cytochrome P450 (CYP) expression and Donor-Derived Cell-Free DNA (dd-cfDNA)
Description
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.
Time Frame
post-operation day 1
Title
Exploring the association between CYP expression and dd-cfDNA
Description
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.
Time Frame
post-operation day 4
Title
Exploring the association between CYP expression and dd-cfDNA
Description
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.
Time Frame
post-operation month 1
Title
Exploring the association between CYP expression and dd-cfDNA
Description
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.
Time Frame
post-operation month 2
Title
Exploring the association between CYP expression and dd-cfDNA
Description
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.
Time Frame
post-operation month 3
Title
Exploring the association between CYP expression and dd-cfDNA
Description
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.
Time Frame
post-operation month 4
Title
Exploring the association between CYP expression and dd-cfDNA
Description
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.
Time Frame
post-operation month 5
Title
Exploring the association between CYP expression and dd-cfDNA
Description
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.
Time Frame
post-operation month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Personalization of Immunosuppressive Treatment for Organ Transplant Recipients

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