Trial reportBMJ open2021
Application of the iBox prognostication system as a surrogate endpoint in the TRANSFORM randomised controlled trial: proof-of-concept study.
Trial report in BMJ open, 2021. 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 24 papers, 2 of them syntheses 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.
A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation
Multicenter International Observational Study to Build and Validate Multidimensional Risk Score in the Clinical Setting of Kidney Allograft Biopsies to Predict Long-term Allograft Survival
Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.
- Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function.The Cochrane database of systematic reviews · 2025Pooled it
- Belatacept in Kidney Transplantation: What Are the True Benefits? A Systematic Review.Frontiers in medicine · 2022Pooled it
- Efficacy and Safety of Bleselumab in Preventing the Recurrence of Primary Focal Segmental Glomerulosclerosis in Kidney Transplant Recipients: A Phase 2a, Randomized, Multicenter Study.Transplantation · 2024Trial
- Case Report: Long-term observations from the tacrolimus weaning randomized clinical trial depicts the challenging aspects for determination of low-immunological risk patients.Frontiers in immunology · 2022Trial
- Beyond Tacrolimus: Toward Personalized Immunosuppression in Heart Transplantation.Journal of cardiac failure · 2026Review
- Unboxing iBox: A Critical Appraisal of Its Measurement Properties for Predicting Kidney Allograft Failure.Kidney medicine · 2026Review
- Qualified prediction system for allograft failure in real world settings: extended validation study.BMJ medicine · 2026Article
- Donor-derived cell-free DNA and its utility in kidney transplantation: A myth or a reality.World journal of nephrology · 2025Review
- Branding a New Technological Outlook for Future Orthopaedics.Bioengineering (Basel, Switzerland) · 2025Review
- Advances and challenges in kidney fibrosis therapeutics.Nature reviews. Nephrology · 2025Review
- Systemic inflammation is an important risk factor and predictor of graft loss and mortality one year after kidney transplantation.Frontiers in immunology · 2025Article
- Tacrolimus intrapatient variability and rejection are associated with inferior allograft outcomes after kidney transplantation.Frontiers in nephrology · 2025Article
- Plasma total and donor-derived cell-free DNA predict survival in kidney transplant recipients.Frontiers in transplantation · 2025Article
- Artificial Intelligence in Nephrology: Clinical Applications and Challenges.Kidney medicine · 2025Review
- The Banff 2022 Kidney Meeting Work Plan: Data-driven refinement of the Banff Classification for renal allografts.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2024Article
- Continuous surveillance for kidney transplant rejection: ready for clinical trials?Clinical kidney journal · 2024Article
- Proceedings of the 2024 Transplant AI Symposium.Frontiers in transplantation · 2024Article
- Predicting long-term outcomes of kidney transplantation in the era of artificial intelligence.Scientific reports · 2023Article
- Validation of a prediction system for risk of kidney allograft failure in pediatric kidney transplant recipients: An international observational study.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2023Observational
- Longitudinal estimated glomerular filtration rate (eGFR) modeling in long-term renal function to inform clinical trial design in kidney transplantation.Clinical and translational science · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 12 institutions in 9 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesDevelopment of pharmaceutical agents in transplantation is currently limited by long waits for hard endpoints. We applied a validated integrative risk-prognostication system integrative Box (iBox) as a surrogate endpoint to the TRANSFORM Study, a large randomised controlled trial, to project individual patient long-term kidney allograft survival from 1 year to 11 years after randomisation.
designPost-hoc analysis of a randomised open-label controlled trial.
settingMulticentre study including 186 centres in 42 countries worldwide.
participants2037 de novo kidney transplant recipients.
interventionParticipants were randomised (1:1) to receive everolimus with reduced-exposure calcineurin inhibitor (EVR+rCNI) or mycophenolic acid with standard-exposure CNI (MPA+sCNI). PRIMARY OUTCOME MEASURE: The iBox scores were computed for each participant at 1 year after randomisation using functional, immunological and histological parameters. Individual long-term death-censored allograft survival over 4, 6 and 11 years after randomisation was projected with the iBox risk-prognostication system.
resultsOverall, 940 patients receiving EVR+rCNI and 932 receiving MPA+sCNI completed the 1-year visit. iBox scores generated at 1 year yielded graft survival prediction rates of 90.9% vs 92.1%, 87.9% vs 89.5%, and 80.0% vs 82.4% in the EVR+rCNI versus MPA+sCNI arms at 4, 6, and 11 years post-randomisation, respectively (all differences below the 10% non-inferiority margin defined by study protocol). Inclusion of immunological and histological Banff diagnoses parameters in iBox scores resulted in comparable and non-inferior predicted graft survival for both treatments.
conclusionsThis proof-of-concept study provides the first application of a validated prognostication system as a surrogate endpoint in the field of transplantation. The iBox system, by projecting kidney allograft survival up to 11 years post-randomisation, confirms the non-inferiority of EVR+rCNI versus MPA+sCNI regimen. Given the current process engaged for surrogate endpoints qualification, this study illustrates the potential to fast track development of pharmaceutical agents. TRIAL REGISTRATION NUMBER: TRANSFORM trial: NCT01950819.iBox prognostication system: NCT03474003.
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Registered trials
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.