Kidney Week

Abstract: TH-OR104

Donor-Derived Cell-Free DNA-Based vs. Invasive Monitoring in Kidney Transplantation: A Multinational Randomized Controlled Trial

Session Information

• The Next Frontier in Kidney Transplantation: Omics, Gene Editing, and Precision Medicine
  October 22, 2026 | Location: Mile High Ballroom 4A, Convention Center
  Abstract Time: 05:10 PM - 05:20 PM

Category: Transplantation

• 2002 Transplantation: Clinical

Authors

• Brousse, Romain H J, Université Paris Cité, Paris Institute for Transplantation and Organ Regeneration, Paris, France

Romain H J Brousse, MD, MSc

• Lefaucheur, Carmen, Université Paris Cité, Paris Institute for Transplantation and Organ Regeneration, Paris, France

Carmen Lefaucheur, MD, PhD

• Aubert, Olivier, Necker Hospital Transplantation Department, Paris, France

Olivier Aubert, MD, PhD

• Legendre, Christophe M., Necker Hospital Transplantation Department, Paris, France

Christophe M. Legendre, MD

• Anglicheau, Dany, Necker Hospital Transplantation Department, Paris, France

Dany Anglicheau, MD, PhD

• Budde, Klemens, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany

Klemens Budde, MD

• Halleck, Fabian, Charite - Universitatsmedizin Berlin, Berlin, BE, Germany

Fabian Halleck, DrMed

• Giral, Magali, Centre de Recherche en Transplantation et Immunologie, Nantes, Pays de la Loire, France

Magali Giral

• Elias, Michelle, Université Paris Cité, Paris Institute for Transplantation and Organ Regeneration, Paris, France

Michelle Elias, MD, MSc

• Bestard, Oriol, Hospital Universitari Vall d'Hebron, Barcelona, CT, Spain

Oriol Bestard, MD, PhD

• Loupy, Alexandre, Université Paris Cité, Paris Institute for Transplantation and Organ Regeneration, Paris, France

Alexandre Loupy, MD, PhD

Background

Whether a dd-cfDNA-based monitoring can safely reduce the need for biopsy has not been tested in a multicenter randomized trial.

Methods

We conducted a randomized controlled trial involving kidney transplant recipients at 7 centers in 4 European countries between December 2021 and May 2024. At the time of transplantation, participants were randomly assigned to a non-invasive monitoring with dd-cfDNA, or to an invasive monitoring with allograft biopsy performed for cause or for surveillance of rejection. The primary endpoint was the rate of kidney allograft biopsies performed between months 3 and 12. Secondary safety endpoints included death, graft loss, acute rejection, and graft function at 12 months, along with hospitalization and immunosuppressant adherence.

Results

In all, 332 patients were included : 168 in the dd-cfDNA-based monitoring group, and 164 in the invasive monitoring group. Between months 3 and 12 after transplantation, the dd-cfDNA-based monitoring group underwent 49% fewer biopsies than the invasive monitoring group (incidence rate ratio [IRR], 0.51; P<0.001). Safety outcomes were similar in the two groups: death or graft loss occurred during the trial in 12 of 168 patients (7.1%) in the dd-cfDNA-based monitoring group and 10 of 164 (6.1%) in the invasive monitoring group. Biopsy-proven acute rejection occurred in 12 of 168 (7.1%) and 12 of 164 (7.3%), respectively. Mean eGFR at 12 months was 53.4 20 mL/min in the dd-cfDNA-based monitoring group and 55.9 mL/min in the invasive monitoring group (p = 0.449). Targeted biopsies triggered in high-risk patients frequently revealed subclinical rejection and other allograft injuries.

Conclusion

In kidney transplant recipients, a non-invasive monitoring strategy based on dd-cfDNA halved allograft biopsies during the first year of transplantation without compromising safety.

Cumulative Number of Biopsies in the Intention-to-Treat Population of the Trial.