Personalization of Immunosuppressive Treatment for Organ Transplant Recipients

NCT05747053 | Terminated FDA Device

• 1 other identifier: NCR191914
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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.

  post-operation day 1 and four. Pos-operation months 1, 2, 3,4,5,6

• PAXGene,

  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

  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 Outcomes (8)

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

  post-operation day 1

• Exploring the association between CYP expression and dd-cfDNA

  post-operation day 4

• Exploring the association between CYP expression and dd-cfDNA

  post-operation month 1

• Exploring the association between CYP expression and dd-cfDNA

  post-operation month 2

• Exploring the association between CYP expression and dd-cfDNA

  post-operation month 3

Study Arms (1)

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; Diagnostic Test: PAXGene

Interventions

AlloSure DIAGNOSTIC_TEST

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.

AlloSure Assay prediction of Anti-body Mediated Rejection

PAXGene DIAGNOSTIC_TEST

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.

AlloSure Assay prediction of Anti-body Mediated Rejection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

subjects with kidney transplants

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• George Washington University: lead
• CareDx: collaborator
• VirginiaBio Analytics, LLC: collaborator

Study Sites (1)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic; Acute Kidney Injury; Kidney Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 28, 2023
• Study Start: October 1, 2020
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

US (1)