Kidney Transplant Immunosuppression
Conditions
Keywords
Belatacept Monotherapy, Kidney Transplant Recipients, Immunosuppression, Weaning, DNA Testing, Gene Expression
Brief summary
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_TESTAllosure and TruGraf
Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.
OTHERImmunosuppression Taper
An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of acute kidney graft rejection | 12 months after informed consent | Number of patients with biopsy-proven acute kidney graft rejection |
| Incidence of facilitation to Belatacept monotherapy | 12 months after the first study visit | Percentage of subjects successfully weaned to a Belatacept monotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean | 12 months after informed consent | 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. |
| Patient Survival after Immunosuppression Wean | 12 months after informed consent | Number of patients who died |
| Incidence of de-novo donor specific antibodies (dnDSA) | 12 months after informed consent | 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. |
| Incidence of Proteinuria after Immunosuppression Wean | 12 months after informed consent | Proteinuria will be detected by a semiquantitative method of the protein concentration in urine. |
| Kidney Graft Failure after Immunosuppression Wean | 12 months after informed consent | Number of patients with kidney graft failure. Graft failure is defined as date of patient death or date of re-transplant |
Countries
United States
Outcome results
None listed