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NCT04786067
Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression
Phase 4 trial testing Belatacept in Kidney Transplant Immunosuppression in 25 participants. Completed in 30 July 2025.
10 July 2025
Quick facts
| Lead sponsor | University of Texas Southwestern Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 28 July 2021 |
| Primary completion | 10 July 2025 |
| Estimated completion | 30 July 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Belatacept (BELATACEPT) — full drug profile →
Conditions studied
- Kidney Transplant Immunosuppression — all drugs for Kidney Transplant Immunosuppression →
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):
-
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT04786067
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04786067 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
- Last refreshed: 12 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04786067.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing