Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression

NCT04786067 | Completed Phase 4 FDA Drug

• 2 other identifiers: STU-2020-1339CTA202012-0033
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to identify kidney transplant patients that can be transitioned from multi-drug immunosuppression therapy to Belatacept monotherapy, using cell free DNA and gene expression as markers of immune quiescence. The primary objective will be to determine if donor derived-cell free DNA (AlloSure) can be utilized to facilitate Belatacept monotherapy, and to determine if Belatacept is safe and effective as immunosuppression in kidney transplant recipients. The secondary objective is to determine the utility of AlloMap as a predictor of immune quiescence and tolerance of immunosuppressive de-escalation to Belatacept monotherapy, and to evaluate the performance of iBox in predicting adverse outcomes in patients transitioned to Belatacept monotherapy

Conditions

Kidney Transplant Immunosuppression

Outcome Measures

Primary Outcomes (1)

• Number of patients with acute kidney graft rejection

  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

Secondary Outcomes (7)

• Number of patients who died

  12 months after the start of immunosuppression wean, up to 36 months

• Number of patients with kidney graft failure

  12 months after the start of immunosuppression wean

• Mean change in Estimated Glomerular Filtration Rate (eGFR)

  Baseline, 12 months after the start of immunosuppression wean

• Number of participants with Proteinuria

  12 months after the start of immunosuppression wean

• Number of participants with appearance of de-novo donor specific antibodies (dnDSA)

  12 months after the start of immunosuppression wean

Study Arms (1)

Immunosuppression Taper

EXPERIMENTAL

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.

Drug: Belatacept

Interventions

Belatacept DRUG

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.

Immunosuppression Taper

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior or concurrent non-kidney organ transplants
• Presence of BK nephropathy in current graft
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• CareDx: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• David Wojciechowski, DO

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Cyrus Feizpour, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of the Kidney Transplantation Program

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 8, 2021
• Study Start: July 28, 2021
• Primary Completion: July 10, 2025
• Study Completion: July 30, 2025
• Last Updated: January 12, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)