Trial reportTransplantation2017
Incidence of Posttransplantation Diabetes Mellitus in De Novo Kidney Transplant Recipients Receiving Prolonged-Release Tacrolimus-Based Immunosuppression With 2 Different Corticosteroid Minimization Strategies: ADVANCE, A Randomized Controlled Trial.
Trial report in Transplantation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01304836 (Investigating New Onset Diabetes Mellitus in Kidney Transplant Recipients Receiving an Advagraf-Based Immunosuppressive Regimen With or Without Corticosteroids - A Multicenter, Two Arm, Randomized, Open Label Clinical Study), which is not on this map. Cited by 22 papers.
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.
Investigating New Onset Diabetes Mellitus in Kidney Transplant Recipients Receiving an Advagraf-Based Immunosuppressive Regimen With or Without Corticosteroids - A Multicenter, Two Arm, Randomized, Open Label Clinical Study
Who cites it
22 citing papers in PubMed, 51 citations in OpenAlex.
- Tacrolimus-resistant regulatory T cells: Combining the best of both worlds?Molecular therapy. Advances · 2026Article
- Post-transplant metabolic dysregulation: Insights and implications for kidney graft survival.World journal of nephrology · 2026Review
- Kidney transplantation beyond immunosuppression: shifting the focus from graft survival to patient health.Frontiers in immunology · 2026Review
- Steroid Avoidance With Low-Dose Tacrolimus is Safe and Effective in the Long-Term for Kidney Transplant Recipients.Kidney international reports · 2025Article
- Kidney Transplant: More than Immunological Problems.Journal of clinical medicine · 2025Review
- Diabetes Mellitus in Kidney Transplant Recipients: New Horizons in Treatment.Journal of clinical medicine · 2025Review
- Managing Post-Transplant Diabetes Mellitus after Kidney Transplantation: Challenges and Advances in Treatment.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Long-term Prolonged-release Tacrolimus-based Immunosuppression in De Novo Kidney Transplant Recipients: 5-Y Prospective Follow-up of Patients in the ADVANCE Study.Transplantation direct · 2023Article
- Utility of salivary mycophenolic acid concentration monitoring: Modeling and Monte Carlo validation approach.Pharmacology research & perspectives · 2022Article
- A Randomized Controlled Trial on Safety of Steroid Avoidance in Immunologically Low-Risk Kidney Transplant Recipients.Kidney international reports · 2022Article
- Role of hypertension in kidney transplant recipients.Journal of human hypertension · 2021Review
- Diabetes mellitus in dialysis and renal transplantation.Therapeutic advances in endocrinology and metabolism · 2021Review
- Delayed diagnoses of mitochondrial cytopathies in patients presenting with end stage kidney disease: two case reports.BMC nephrology · 2020Article
- Late Conversion From Calcineurin Inhibitors to Belatacept in Kidney-Transplant Recipients Has a Significant Beneficial Impact on Glycemic Parameters.Transplantation direct · 2020Article
- Adverse effects of mycophenolic acid in renal transplant recipients: gender differences.International journal of clinical pharmacy · 2019Article
- Non-immunological complications following kidney transplantation.F1000Research · 2019Review
- Randomized Controlled Trial Assessing the Impact of Tacrolimus Versus Cyclosporine on the Incidence of Posttransplant Diabetes Mellitus.Kidney international reports · 2018Article
- Recent advances in kidney transplantation: a viewpoint from the Descartes advisory board.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2018Review
- Tacrolimus Granules for Oral Suspension as Post-Transplant Immunosuppression in Routine Medical Practice in France: The OPTIMOD Study.Annals of transplantation · 2018Observational
- New-onset diabetes after kidney transplantation: Incidence and associated factors.World journal of diabetes · 2018Article
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 4 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundADVANCE (NCT01304836) was a phase 4, multicenter, prospectively randomized, open-label, 24-week study comparing the incidence of posttransplantation diabetes mellitus (PTDM) with 2 prolonged-release tacrolimus corticosteroid minimization regimens.
methodsAll patients received prolonged-release tacrolimus, basiliximab, mycophenolate mofetil and 1 bolus of intraoperative corticosteroids (0-1000 mg) as per center policy. Patients in arm 1 received tapered corticosteroids, stopped after day 10, whereas patients in arm 2 received no steroids after the intraoperative bolus. The primary efficacy variable was the diagnosis of PTDM as per American Diabetes Association criteria (2010) at any point up to 24 weeks postkidney transplantation. Secondary efficacy variables included incidence of composite efficacy failure (graft loss, biopsy-proven acute rejection or severe graft dysfunction: estimated glomerular filtration rate (Modification of Diet in Renal Disease-4) <30 mL/min per 1.73 m), acute rejection and graft and patient survival.
resultsThe full-analysis set included 1081 patients (arm 1: n = 528, arm 2: n = 553). Baseline characteristics and mean tacrolimus trough levels were comparable between arms. Week 24 Kaplan-Meier estimates of PTDM were similar for arm 1 versus arm 2 (17.4% vs 16.6%; P = 0.579). Incidence of composite efficacy failure, graft and patient survival, and mean estimated glomerular filtration rate were also comparable between arms. Biopsy-proven acute rejection and acute rejection were significantly higher in arm 2 versus arm 1 (13.6% vs 8.7%, P = 0.006 and 25.9% vs 18.2%, P = 0.001, respectively). Tolerability profiles were comparable between arms.
conclusionsA prolonged-release tacrolimus, basiliximab, and mycophenolate mofetil immunosuppressive regimen is efficacious, with a low incidence of PTDM and a manageable tolerability profile over 24 weeks of treatment. A lower incidence of biopsy-proven acute rejection was seen in patients receiving corticosteroids tapered over 10 days plus an intraoperative corticosteroid bolus versus those receiving an intraoperative bolus only.
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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.