Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2025
Donor-derived cell-free DNA monitoring for early diagnosis of antibody-mediated rejection after kidney transplantation: a randomized trial.
Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Donor-derived Cell-free DNA for Early Diagnosis of Antibody-mediated Rejection in Kidney Transplant Recipient with Donor-specific Antibodies
GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial: A Multi-Center Registry Study Assessing Transplanted Kidney Status
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Combined Biomarker Approach Using Extracellular Vesicles, Donor-Derived Cell-Free DNA, and Donor-Specific Antibodies for Monitoring Renal Allograft Function: A Narrative Review.Medicina (Kaunas, Lithuania) · 2026Pooled it
- Reduction in Donor-Derived Cell-Free DNA After Rejection Treatment is Associated With Improved Long Term Allograft Function.Clinical transplantation · 2026Article
- The evolving field of nephrology: what comes next? A report from the European Renal Association Scientific Advisory Board.Clinical kidney journal · 2026Review
- Diagnostic and Prognostic Value of Donor-Derived Cell-Free DNA in Acute Rejection After Kidney Transplantation: A Narrative Review.Diagnostics (Basel, Switzerland) · 2026Review
- Diagnostic modalities in vascularized composite allotransplantation: from histopathology to multimodal strategies.Frontiers in immunology · 2026Review
- Promising non-invasive biomarkers for kidney allograft monitoring: a mini review.Frontiers in immunology · 2026Review
- Real-world utilization patterns and association of dd-cfDNA with biopsy and rejection.Frontiers in medicine · 2026Article
- Donor-Derived Cell-Free DNA as a Non-Invasive Readout of Activity Across the Rejection Continuum.Transplant international : official journal of the European Society for Organ Transplantation · 2026Article
- Longitudinal Monitoring of Donor-Derived Cell-Free DNA Supports Risk Stratification in Kidney Transplant Recipients With Allograft Dysfunction.Transplant international : official journal of the European Society for Organ Transplantation · 2026Article
- Donor-derived cell-free DNA and its utility in kidney transplantation: A myth or a reality.World journal of nephrology · 2025Review
- One tool, multiple gains: anti-CD38 therapy in antibody-mediated rejection.Clinical kidney journal · 2025Article
- Noninvasive Diagnosis of Kidney Allograft Rejection.Journal of the American Society of Nephrology : JASN · 2025Review
- Donor-derived cell-free DNA in solid organ transplantation: analytical considerations, diagnostic performance, and clinical interpretation.Clinical transplantation and research · 2025Review
- Donor-Derived Cell-Free DNA as a Marker for the Efficacy of Daratumumab in Patients With Antibody-Mediated Rejection Post-Heart Transplantation: A Case Series.Pediatric transplantation · 2025Article
- Antibody-mediated rejection-treatment standard.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025Review
- Association of Blood Donor-derived Cell-free DNA Levels With Banff Scores and Histopathological Lesions in Kidney Allograft Biopsies: Results From an Observational Study.Transplantation direct · 2025Article
- Exploring Net Immunosuppressive Status with Torque Teno Virus Viral Load in Kidney Transplant Recipients with High Molecular Injury.Journal of clinical medicine · 2025Article
- Omics data integration analysis identified new biological insights into chronic antibody-mediated rejection (CAMR).Journal of translational medicine · 2025Article
- Donor-Derived Cell-Free DNA in Pancreas-Kidney, Heart-Kidney, and Liver-Kidney Multiorgan Transplant Recipients (MOTR).Transplant international : official journal of the European Society for Organ Transplantation · 2025Article
- Transplant Trial Watch.Transplant international : official journal of the European Society for Organ Transplantation · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
27 authors.
Funding
Abstract
backgroundDonor-derived cell-free DNA (dd-cfDNA) shows good diagnostic performance for the detection of antibody-mediated rejection (AMR) in kidney transplant recipients (KTR). However, the clinical benefits of dd-cfDNA monitoring need to be established. Early diagnosis of AMR at potentially reversible stages may be increasingly important due to emerging treatment options for AMR. We hypothesized that monitoring dd-cfDNA in KTR with de novo donor-specific anti-HLA antibodies (dnDSA) and performing kidney biopsy in case of increased dd-cfDNA may reduce time to AMR diagnosis in comparison with clinical indication biopsy.
methodsIn this diagnostic, single-center, open-label, randomized clinical trial, we assigned 40 KTR with prevalent dnDSA and estimated glomerular filtration rate ≥20 mL/min/1.73 m2, but without previous biopsy-proven AMR, to either dd-cfDNA-guided biopsy (intervention group) or clinician-guided biopsy (control group) over a 12-month period. In both groups, dd-cfDNA was assessed at inclusion and 1, 3, 6, 9 and 12 months. In the intervention group, dd-cfDNA >50 copies/mL indicated a biopsy. Biopsies for clinical indication could be performed at any point during the study period in both groups. A protocol biopsy was scheduled after 12 months for patients without dd-cfDNA-guided biopsy or clinical indication biopsy until study completion. The primary endpoint was time from study inclusion to diagnosis of active or chronic active AMR.
resultsThirty-nine of 40 patients had functioning grafts at study completion. From these, 26 patients underwent biopsy, 13 in each group. AMR was diagnosed earlier in the intervention group than in the control group [median 2.8 months, interquartile range (IQR) 1.7-5.3 vs median 14.5 months, IQR 13.3-16.7, P = .003]. Longitudinal dd-cfDNA monitoring had 77% positive predictive value and 85% negative predictive value for AMR.
conclusionsDd-cfDNA-guided biopsy in KTR with prevalent dnDSA can reduce the time to AMR diagnosis and hereby expedite therapy initiation.
trial registrationClinicalTrials.gov, NCT04897438.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.