Personalization of Immunosuppressive Treatment for Organ Transplant Recipients

Terminated

• Conditions: Kidney Injury; Kidney Transplant; Complications; Kidney Disease, Chronic; Kidney Failure, Acute; Kidney Ischemia; Kidney Failure, Chronic; Kidney Transplant Rejection; Kidney Failure; Kidney Diseases; Kidney Transplant Infection
• Interventions: Diagnostic Test: AlloSure; Diagnostic Test: PAXGene

• Registration Number: NCT05747053
• Lead Sponsor: George Washington University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-01
• Primary Completion: 2022-12-08
• Study Completion: 2022-12-08
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 105

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.

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AlloSure Assay prediction of Anti-body Mediated Rejection	AlloSure	Determine whether AlloSure predicts the incidence of active, chronic Anti-body Mediated Rejection and cellular rejection in high risk patients
AlloSure Assay prediction of Anti-body Mediated Rejection	PAXGene	Determine whether AlloSure predicts the incidence of active, chronic Anti-body Mediated Rejection and cellular rejection in high risk patients

Primary Outcome Measures

Name	Time	Method
PAXGene,	1 PAXgene tube will be collected 3 months post operation	The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
PAXGene	1 PAXgene tube will be collected one year post operation	The test will be used to develop an algorithm to personalize immunosuppressive medication intake.
AlloSure value change	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

George Washington University; 🇺🇸 Washington, District of Columbia, United States