ArticleEClinicalMedicine2023
Optimized immunosuppression to prevent graft failure in renal transplant recipients with HLA antibodies (OuTSMART): a randomised controlled trial.
Article in EClinicalMedicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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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.
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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.
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Who cites it
17 citing papers in PubMed, 25 citations in OpenAlex.
- Impact of pretransplant donor-specific antibodies and human leukocyte antigen mismatches on graft and patient outcomes: A cohort from Saudi Arabia.World journal of transplantation · 2026Article
- Tailoring HLA antibody monitoring post-transplantation.Pediatric nephrology (Berlin, Germany) · 2026Article
- Role of microvascular pericyte dysfunction in antibody-mediated rejection following kidney transplantation.Renal failure · 2025Article
- Noninvasive Diagnosis of Kidney Allograft Rejection.Journal of the American Society of Nephrology : JASN · 2025Review
- Renal Allograft Pathology Classifications: Contemporary Updates and Diagnostic Utility.Cureus · 2025Review
- Antibody-mediated rejection-treatment standard.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025Review
- Chronic Allograft Nephropathy-A Narrative Review of Its Pathogenesis, Diagnosis, and Evolving Management Strategies.Biomedicines · 2025Review
- Immune Monitoring Goes Viral - Torque Teno Virus for Immunologic Risk Stratification After Kidney Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2025Review
- Early Donor-Specific HLA Antibodies Detected by Screening in the First Month Posttransplant and Kidney Graft Outcomes.Transplant international : official journal of the European Society for Organ Transplantation · 2025Article
- The effect of COVID-19 vaccination on kidney function and HLA antibody formation in patients with end-stage kidney disease and on kidney replacement treatment.Clinical kidney journal · 2024Article
- Utility of Routine Post Kidney Transplant Anti-HLA Antibody Screening.Kidney international reports · 2024Article
- Perspective for Donor-Derived Cell-Free DNA in Antibody-Mediated Rejection After Kidney Transplantation: Defining Context of Use and Clinical Implications.Transplant international : official journal of the European Society for Organ Transplantation · 2024Review
- Clinical Impacts of Allograft Biopsy in Renal Transplant Recipients 10 Years or Longer After Transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2024Article
- HLA class, calcineurin inhibitor levels, and the risk of graft failure in kidney recipients withFrontiers in immunology · 2024Article
- Preventing Rejection of the Kidney Transplant.Journal of clinical medicine · 2023Review
- Impact of T Lymphocytes Isolated from Liver Perfusate of Deceased Brain Donors on Kidney Transplantation: Preliminary Evidence and Future Directions.Journal of clinical medicine · 2023Article
- The Clinical Utility of Post-Transplant Monitoring of Donor-Specific Antibodies in Stable Renal Transplant Recipients: A Consensus Report With Guideline Statements for Clinical Practice.Transplant international : official journal of the European Society for Organ Transplantation · 2023Article
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Authors and funding
33 authors at 20 institutions in 3 countries.
Funding
Abstract
Background: 3% of kidney transplant recipients return to dialysis annually upon allograft failure. Development of antibodies (Ab) against human leukocyte antigens (HLA) is a validated prognostic biomarker of allograft failure. We tested whether screening for HLA Ab, combined with an intervention to improve adherence and optimization of immunosuppression could prevent allograft failure. Methods: Prospective, open-labelled randomised biomarker-based strategy (hybrid) trial in 13 UK transplant centres [EudraCT (2012-004308-36) and ISRCTN (46157828)]. Patients were randomly allocated (1:1) to unblinded or double-blinded arms and screened every 8 months. Unblinded HLA Ab+ patients were interviewed to encourage medication adherence and had tailored optimisation of Tacrolimus, Mycophenolate mofetil and Prednisolone. The primary outcome was time to graft failure in an intention to treat analysis. The trial had 80% power to detect a hazard ratio of 0.49 in donor specific antibody (DSA)+ patients. Findings: From 11/9/13 to 27/10/16, 5519 were screened for eligibility and 2037 randomised (1028 to unblinded care and 1009 to double blinded care). We identified 198 with DSA and 818 with non-DSA. Development of DSA, but not non-DSA was predictive of graft failure. HRs for graft failure in unblinded DSA+ and non-DSA+ groups were 1.54 (95% CI: 0.72 to 3.30) and 0.97 (0.54-1.74) respectively, providing no evidence of an intervention effect. Non-inferiority for the overall unblinded versus blinded comparison was not demonstrated as the upper confidence limit of the HR for graft failure exceeded 1.4 (1.02, 95% CI: 0.72 to 1.44). The only secondary endpoint reduced in the unblinded arm was biopsy-proven rejection. Interpretation: Intervention to improve adherence and optimize immunosuppression does not delay failure of renal transplants after development of DSA. Whilst DSA predicts increased risk of allograft failure, novel interventions are needed before screening can be used to direct therapy. Funding: The National Institute for Health Research Efficacy and Mechanism Evaluation programme grant (ref 11/100/34).
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