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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."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunosuppression Taper | Experimental | 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. |
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| Multi-Drug Regimen | Other | Eligible patients who are not deemed immune quiescent will continue on a multi-drug regimen. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allosure and TruGraf | Diagnostic Test | Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute kidney graft rejection | Number of patients with biopsy-proven acute kidney graft rejection | 12 months after informed consent |
| Incidence of facilitation to Belatacept monotherapy | Percentage of subjects successfully weaned to a Belatacept monotherapy | 12 months after the first study visit |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival after Immunosuppression Wean | Number of patients who died | 12 months after informed consent |
| Kidney Graft Failure after Immunosuppression Wean | Number of patients with kidney graft failure. Graft failure is defined as date of patient death or date of re-transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Wojciechowski, DO | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2024 |
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| Immunosuppression Taper | Other | An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent. |
|
| 12 months after informed consent |
| Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean | Estimated glomerular filtration rate (eGFR) in blood will be measured at the beginning of enrollment and the difference will be measured to the end of the study as a measure of change in kidney function. | 12 months after informed consent |
| Incidence of Proteinuria after Immunosuppression Wean | Proteinuria will be detected by a semiquantitative method of the protein concentration in urine. | 12 months after informed consent |
| Incidence of de-novo donor specific antibodies (dnDSA) | HLA type I and type II in blood will be used to detect the presence of de-novo donor specific antibodies (dnDSA) in those who have started the immunosuppression wean. | 12 months after informed consent |
| Mar 28, 2024 |
| Prot_SAP_000.pdf |