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Completed NCT04786067

Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

Conditions: Kidney Transplant Immunosuppression

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 25
Sponsor: University of Texas Southwestern Medical Center

Location: UT Southwestern Medical Center Dallas Texas

Summary

The purpose of the study is to identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression as markers of immune quiescence. The primary objective will be to determine if donor derived-cell free DNA (AlloSure) can be utilized to facilitate Belatacept monotherapy, and to determine if Belatacept is safe and effective as immunosuppression in kidney transplant recipients. The secondary objective is to determine the utility of AlloMap as a predictor of immune quiescence and tolerance of immunosuppressive de-escalation to Belatacept monotherapy, and to evaluate the performance of iBox in predicting adverse outcomes in patients transitioned to Belatacept monotherapy

Eligibility Criteria

Inclusion Criteria: * Adult (\>18 years) recipients of a kidney-only transplant, including re-transplants * Non-HLA identical Living or Deceased Donor Grafts * Able to provide informed consent * Absence of donor specific antigens * Stable renal function (eGFR\>40mL/min for 3 months prior to enrollment) * Patients treated with Belatacept as part of de novo immunosuppression or converted to Belatacept with stable kidney function for 3 months (as stated above) * Patients who underwent kidney transplantation at least 9 months prior to study entry Exclusion Criteria: * Prior or concurrent non-kidney organ transplants * Presence of BK nephropathy in current graft * Recipient on any other investigational drug in the 12 weeks prior to inclusion * Patient with history of recent (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04786067). StuddyBuddy aggregates publicly available trial information.