Personalization of Immunosuppressive Treatment for Organ Transplant Recipients (STAART)

George Washington University (GW)

Status and phase: Terminated; Phase 4

Conditions: Kidney Failure; Kidney Diseases; Kidney Transplant; Complications; Kidney Failure, Acute; Kidney Transplant Infection; Kidney Ischemia; Kidney Injury; Kidney Disease, Chronic; Kidney Transplant Rejection; Kidney Failure, Chronic

Treatments: Diagnostic Test: PAXGene; Diagnostic Test: AlloSure

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05747053

NCR191914

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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)

Trial design

105 participants in 1 patient group

AlloSure Assay prediction of Anti-body Mediated Rejection

Description:

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

Treatment:

Diagnostic Test: AlloSure

Diagnostic Test: PAXGene