Trials Sponsors Conditions Drugs Pricing

Conditions

Kidney Transplant Immunosuppression

Keywords

Belatacept MonotherapyKidney Transplant RecipientsImmunosuppressionWeaningDNA TestingGene Expression

Outcome Measures

Primary Outcomes (2)

Incidence of acute kidney graft rejection
Number of patients with biopsy-proven acute kidney graft rejection
12 months after informed consent
Incidence of facilitation to Belatacept monotherapy
Percentage of subjects successfully weaned to a Belatacept monotherapy
12 months after the first study visit

Secondary Outcomes (5)

Patient Survival after Immunosuppression Wean
12 months after informed consent
Kidney Graft Failure after Immunosuppression Wean
12 months after informed consent
Mean change in Estimated Glomerular Filtration Rate (eGFR) after Immunosuppression Wean
12 months after informed consent
Incidence of Proteinuria after Immunosuppression Wean
12 months after informed consent
Incidence of de-novo donor specific antibodies (dnDSA)
12 months after informed consent

Study Arms (2)

Immunosuppression Taper

EXPERIMENTAL

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.

Diagnostic Test: Allosure and TruGrafOther: Immunosuppression Taper

Multi-Drug Regimen

OTHER

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

Diagnostic Test: Allosure and TruGraf

Interventions

Allosure and TruGrafDiagnostic test

Precision medicine will be employed to withdraw immunosuppression in kidney transplant recipients.

Immunosuppression TaperMulti-Drug Regimen

Immunosuppression TaperOther

An immunosuppression taper will be employed over a 12-month period for those that are deemed immune quiescent.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Completion of the parent study (STU-2020-1339)
Able to provide informed consent

Sponsors & Collaborators

University of Texas Southwestern Medical Center
Otherlead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Study Officials

David Wojciechowski, DO
University of Texas Southwestern Medical Center
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor, Internal Medicine

Study Record Dates

First Submitted

March 21, 2024

First Posted

March 29, 2024

Study Start

June 14, 2024

Actual (reported)

Primary Completion

August 2026

Estimated (date passed)

Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Immunosuppression Taper

Multi-Drug Regimen

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Immunosuppression Taper

Multi-Drug Regimen

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations