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Monoclonal Antibodies
Immunosuppression Taper for Immunosuppression
N/A
Waitlist Available
Led By David Wojciechowski, DO
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after informed consent
Awards & highlights
Study Summary
"This trial aims to see if it is safe and effective to reduce the use of immunosuppressant drugs for another year in kidney transplant patients who were previously part of a study using Belatacept
Who is the study for?
This trial is for kidney transplant recipients who completed the parent study STU-2020-1339, can consent to participate, don't have donor-specific antibodies, and have stable kidney function (eGFR>40mL/min). Pregnant or lactating women, those planning pregnancy during the trial, individuals with significant protein in urine or liver issues are excluded.Check my eligibility
What is being tested?
The study tests if it's safe and effective to reduce immunosuppression drugs to just belatacept over an additional 12 months. It uses DNA testing (Allosure) and gene expression profiling (TruGraf) for monitoring patients previously on belatacept monotherapy.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally reducing immunosuppression may increase risk of organ rejection or infection. Belatacept itself can cause side effects like high blood pressure, anemia, diarrhea or swelling.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after informed consent
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after informed consent
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of acute kidney graft rejection
Incidence of facilitation to Belatacept monotherapy
Secondary outcome measures
Incidence of Proteinuria after Immunosuppression Wean
Incidence of de-novo donor specific antibodies (dnDSA)
Kidney Graft Failure after Immunosuppression Wean
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Multi-Drug RegimenExperimental Treatment1 Intervention
Eligible patients who are not deemed immune quiescent will continue on a multi-drug regimen.
Group II: Immunosuppression TaperExperimental Treatment2 Interventions
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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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,050 Previous Clinical Trials
1,054,335 Total Patients Enrolled
David Wojciechowski, DOPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
1 Previous Clinical Trials
25 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary objective that this medical study aims to achieve?
"The main focus of this clinical trial, to be assessed over a 12-month period following obtaining informed consent, is the rate of transition to Belatacept monotherapy. Additional outcomes include Kidney Graft Failure post Immunosuppression Reduction (measured by instances of kidney graft failure), Patient Survival post Immunosuppression Wean (determined by patient mortality rates), and occurrence of de-novo donor-specific antibodies (dnDSA) identified through HLA typing for type I and type II antigens in blood samples during immunosuppression reduction."
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