Personalization of Immunosuppressive Treatment for Organ Transplant Recipients

NCT ID: NCT05747053

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2022-12-08

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

Study Groups

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

AlloSure

Intervention Type: 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.

PAXGene

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CareDx

INDUSTRY

Sponsor Role: collaborator

VirginiaBio Analytics, LLC

UNKNOWN

Sponsor Role: collaborator

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

George Washington University

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

Countries

United States

Other Identifiers

NCR191914

Identifier Type: -

Identifier Source: org_study_id