Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

Conditions

• Kidney Transplant Immunosuppression

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Allosure and TruGraf — DIAGNOSTIC_TEST
  Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.
• Immunosuppression Taper — OTHER
  An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent.

Study Details

The purpose of the study is to provide immunosuppression weaning and/or monitoring for an additional 12-months to evaluate the safety and efficacy of belatacept monotherapy in patients previously enrolled in the clinical trial: "Use of donor derived-cell free DNA (AlloSure) and gene expression profiling (AlloMap Kidney) to facilitate Belatacept monotherapy in kidney transplant patients."

Key Dates

Start date

Jun 14, 2024

Status verified

Jul 2025

Primary completion

Aug 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

24 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Immunosuppression Taper
  Eligible patients who are deemed immune quiescent will undergo sequential withdrawal of immunosuppression medications over a 12-month period from a multi-drug regimen to a Belatacept monotherapy using precision medicine.
• Other: Multi-Drug Regimen
  Eligible patients who are not deemed immune quiescent will continue on a multi-drug regimen.

Primary Outcome Measure

Incidence of acute kidney graft rejection [ Time Frame: 12 months after informed consent ]

Locations (1)

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