Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Allosure and TruGraf, Immunosuppression Taper.
- Who it may be relevant to
- Registry conditions: Kidney Transplant Immunosuppression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Extension Protocol for Subjects Previously Enrolled in the "Use of Donor Derived-cell Free DNA (AlloSure) and Gene Expression Profiling (AlloMap Kidney) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients"
Overview
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."
Interventions
- Diagnostic test Allosure and TruGraf
Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients. - Other Immunosuppression Taper
An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent.
Primary outcome measures
- Incidence of acute kidney graft rejection [Time frame: 12 months after informed consent]
- Incidence of facilitation to Belatacept monotherapy [Time frame: 12 months after the first study visit]
Secondary outcome measures (5)
- Patient Survival after Immunosuppression Wean [Time frame: 12 months after informed consent]
- Kidney Graft Failure after Immunosuppression Wean [Time frame: 12 months after informed consent]
- Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean [Time frame: 12 months after informed consent]
- Incidence of Proteinuria after Immunosuppression Wean [Time frame: 12 months after informed consent]
- Incidence of de-novo donor specific antibodies (dnDSA) [Time frame: 12 months after informed consent]
Eligibility criteria
Inclusion criteria
- Completion of the parent study (STU-2020-1339)
- Able to provide informed consent
- Absence of donor specific antibodies
- Stable renal function (eGFR>40mL/min for 3 months prior to enrollment)
Exclusion criteria
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Significant hepatic impairment
- Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
- Proteinuria > 0.5 g/g creatinine on spot urine sample within 3 months of enrollment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Texas Southwestern Medical Center — Dallas
Identifiers
NCT: NCT06336863 · STU-2023-1151