Belatacept-Only Immunosuppression for Kidney Transplant

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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after informed consent for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of acute kidney graft rejection

Incidence of facilitation to Belatacept monotherapy

Secondary study objectives

Incidence of Proteinuria after Immunosuppression Wean

Incidence of de-novo donor specific antibodies (dnDSA)

Kidney Graft Failure after Immunosuppression Wean

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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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