- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04786067
Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
Use of Donor Derived-cell Free DNA (AlloSure) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: David Wojciechowski, DO
- Phone Number: 214-645-8300
- Email: David.Wojciechowski@UTSouthwestern.edu
Study Locations
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Texas
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Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern Medical Center
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Contact:
- David Wojciechowski, DO
- Email: David.Wojciechowski@UTSouthwestern.edu
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Principal Investigator:
- David Wojciechowski, DO
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Contact:
- Cyrus Feizpour, MD
- Email: cyrus.feizpour@utsouthwestern.edu
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Sub-Investigator:
- Cyrus Feizpour, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 (<3mo), recurrent, or severe (Banff Grade 2 or greater or unable to be treated with steroids) acute rejection episodes
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Significant hepatic impairment
- Bilateral kidney transplantation
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immunosuppression Taper
Patients included in this arm are kidney transplant recipients with stable kidney function currently on or are converting to a Belatacept based immunosuppression regimen.
Eligible patients who are deemed immune quiescent after a 3 month monitoring period will undergo sequential withdrawal of immunosuppression medications over a 12 month period from a three drug regimen to a Belatacept only immunosuppression regimen.
During the total 15 month period patients will be monitored with monthly clinic visits, blood draws for routine monitoring as well as donor derived cell free DNA and genetic testing through KidneyCare to monitor immune suppression.
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Patients will have tapering of their multi-drug immunosuppression, until Belatacept is the sole medication in their immunosuppression regimen.
Belatacept will be administered as an infusion, as is routinely done clinically.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with acute kidney graft rejection
Time Frame: 12 months after the date of the first immunosuppression taper
|
Number of patients with Acute kidney graft rejection confirmed by biopsy by 2017 Banff Criteria. Incidence of biopsy proven acute kidney graft rejection at 12 months after the start of immunosuppression taper |
12 months after the date of the first immunosuppression taper
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients who died
Time Frame: 12 months after the start of immunosuppression wean, up to 36 months
|
Incidence of death will be measured from 12 months after the start of immunosuppresion wean, up to 36 months
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12 months after the start of immunosuppression wean, up to 36 months
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Number of patients with kidney graft failure
Time Frame: 12 months after the start of immunosuppression wean
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Incidence of kidney graft failure will be measured from the start of immunosuppresion wean until 12 months after.
Graft failure is defined as date of patient death or date of retransplant
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12 months after the start of immunosuppression wean
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Mean change in Estimated Glomerular Filtration Rate (eGFR)
Time Frame: Baseline, 12 months after the start of immunosuppression wean
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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.
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Baseline, 12 months after the start of immunosuppression wean
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Number of participants with Proteinuria
Time Frame: 12 months after the start of immunosuppression wean
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Proteinuria will be detected by a semiquantitative method of the protein concentration in urine.
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12 months after the start of immunosuppression wean
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Number of participants with appearance of de-novo donor specific antibodies (dnDSA)
Time Frame: 12 months after the start of immunosuppression wean
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HLA type I and type II in blood will be used to detect the presence of de-novo donor specific antibodies (dnDSA)
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12 months after the start of immunosuppression wean
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Negative predictable value as measured by AlloMap®
Time Frame: 12 months after the start of immunosuppression wean
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Negative predictable value measured by AlloMap®, expressed as a percent, that the patient is not experiencing rejection at the time of testing. AlloMap® is a panel of 20 gene assays, 11 informative and 9 used for normalization and/or quality control, which produces gene expression data used in the calculation of an AlloMap test score - an integer ranging from 0 to 40. Compared with patients in the same post- transplant period, the lower the score, the lower the probability of acute cellular rejection at the time of testing. |
12 months after the start of immunosuppression wean
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Mean prediction score of allograft loss as measured by iBox
Time Frame: 12 months after the start of immunosuppression wean
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iBox is the validated tool for predicting the risk of kidney transplant loss based on artificial intelligence.
Range of score is 0%-100%, higher score indicates better kidney survival.
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12 months after the start of immunosuppression wean
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David Wojciechowski, DO, UT Southwestern Medical Center
- Principal Investigator: Cyrus Feizpour, MD, UT Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU-2020-1339
- CTA202012-0033 (Other Grant/Funding Number: CareDx)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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