Belatacept-Only Immunosuppression for Kidney Transplant

Recruiting in Palo Alto (17 mi)

Overseen by David Wojciechowski, DO

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Texas Southwestern Medical Center

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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."

Eligibility Criteria

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.

Inclusion Criteria

Completion of the parent study (STU-2020-1339)

Able to provide informed consent

Absence of donor specific antibodies

Exclusion Criteria

I am not pregnant, breastfeeding, or planning to become pregnant during the trial.

Proteinuria > 0.5 g/g creatinine on spot urine sample within 3 months of enrollment

I have severe liver problems.

Participant Groups

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.

Group I: Multi-Drug Regimen Experimental Treatment 1 Intervention

Eligible patients who are not deemed immune quiescent will continue on a multi-drug regimen.

Group II: Immunosuppression Taper Experimental Treatment 2 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.

Belatacept is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Nulojix for:

• Prophylaxis of organ rejection in adult patients receiving a kidney transplant

🇪🇺 Approved in European Union as Nulojix for:

• Prophylaxis of organ rejection in adult patients receiving a kidney transplant

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Texas Southwestern Medical Center Dallas, TX

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center Lead Sponsor

References