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NCT04786067

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

Completed Phase 4 Last updated 12 January 2026
What this trial tests

Phase 4 trial testing Belatacept in Kidney Transplant Immunosuppression in 25 participants. Completed in 30 July 2025.

Timeline
28 July 2021
Primary endpoint
10 July 2025
30 July 2025

Quick facts

Lead sponsorUniversity of Texas Southwestern Medical Center
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment25
Start date28 July 2021
Primary completion10 July 2025
Estimated completion30 July 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Texas Southwestern Medical Center

Who can join

18 and older, any sex, with Kidney Transplant Immunosuppression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. The Current State of Donor-Derived Cell-Free DNA Use in Allograft Monitoring in Kidney Transplantation.
    Kueht ML, Dongur LP, Cusick M, Stevenson HL, et al · · 2022 · cited 9× · PMID 36294839 · DOI 10.3390/jpm12101700
  2. Donor-Derived Cell-Free DNA for Kidney Allograft Surveillance after Conversion to Belatacept: Prospective Pilot Study.
    Osmanodja B, Akifova A, Oellerich M, Beck J, et al · · 2023 · cited 8× · PMID 36983437 · DOI 10.3390/jcm12062437
  3. Free-Circulating Nucleic Acids as Biomarkers in Patients After Solid Organ Transplantation.
    Raszeja-Wyszomirska J, Macech M, Kolanowska M, Krawczyk M, et al · · 2023 · cited 6× · PMID 37580899 · DOI 10.12659/aot.939750
  4. Donor-derived cell-free DNA and its utility in kidney transplantation: A myth or a reality.
    Khalil MAM, Sadagah NM, Mahmood HHK, Altom AA, et al · · 2025 · PMID 41479839 · DOI 10.5527/wjn.v14.i4.109099
  5. Belatacept and regulatory T cells in transplantation: synergistic strategies for immune tolerance and graft survival.
    Kim GR, Nam KH, Choi JM. · · 2024 · PMID 39690903 · DOI 10.4285/ctr.24.0057

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