Clinical trial NCT05747053: Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Official title: Surveillance Testing Utilizing AlloSure to Assess Rejection Following Transplantation and Personalization of Immunosuppressive Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: 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
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: CareDx
name: VirginiaBio Analytics, LLC
First posted: 2023-02-28
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with kidney transplants

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.


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)

Primary outcomes:
measure: AlloSure value change
timeFrame: post-operation day 1 and four. Pos-operation months 1, 2, 3,4,5,6
measure: PAXGene,
timeFrame: 1 PAXgene tube will be collected 3 months post operation
measure: PAXGene
timeFrame: 1 PAXgene tube will be collected one year post operation
Secondary outcomes:
measure: Exploring the association between Cytochrome P450 (CYP) expression and Donor-Derived Cell-Free DNA (dd-cfDNA)
timeFrame: post-operation day 1
measure: Exploring the association between CYP expression and dd-cfDNA
timeFrame: post-operation day 4
measure: Exploring the association between CYP expression and dd-cfDNA
timeFrame: post-operation month 1
measure: Exploring the association between CYP expression and dd-cfDNA
timeFrame: post-operation month 2
measure: Exploring the association between CYP expression and dd-cfDNA
timeFrame: post-operation month 3
measure: Exploring the association between CYP expression and dd-cfDNA
timeFrame: post-operation month 4
measure: Exploring the association between CYP expression and dd-cfDNA
timeFrame: post-operation month 5
measure: Exploring the association between CYP expression and dd-cfDNA
timeFrame: post-operation month 6
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
Study officials:
References: