Influence of Induction Therapy On the Efficacy of Everolimus vs Mycophenolate Based Regimen in De Novo Renal Transplant Recipients.
Bibliographic record
Abstract
Introduction: Induction therapy has been shown to lower the risk of acute rejection in renal transplant recipients (RTxR). In this 12-month (M), multicenter (52 US & Canadian centers), randomized, open-label non-inferiority study, we report the outcome by induction therapy (basiliximab vs rabbit anti-thymocyte globulin [rATG]) on the efficacy of everolimus (EVR)+low-dose tacrolimus (LTac) vs mycophenolate mofetil (MMF)+standard-dose Tac (STac) regimen in de novo RTxR. Methods: De novo (n=613) RTxR received EVR (starting dose of 0.75 mg bid)+LTac (n=309) or MMF (2 g/day)+STac (n=304). Induction therapy was based on PRA levels; if PRA<20%, pts received basiliximab (EVR+LTac, n=213; MMF+STac, n=210) and if PRA ≥20% or at high risk (those receiving DCD or ECD) pts received rATG (EVR+LTac, n=96; MMF+STac, n=94). Steroids were administered as per local practice. Composite efficacy failure rate at 12M included tBPAR, graft loss, death, or lost to follow-up. Renal function (eGFR) was estimated at 12M using MDRD formula. Results: HLA mismatches (HLA ≥3) and ECD were more frequent in EVR+LTac group regardless of induction therapy. Induction with rATG resulted in numerically higher composite efficacy failure rates vs basiliximab in both treatment regimens; moreover, the incidence rates of the efficacy endpoints between treatments did not reach the statistical significance (Table). However, in basliliximab induction group, the incidence of tBPAR was significantly higher with EVR+LTac vs MMF+STac (p<0.05); nevertheless, the incidence of graft loss was significantly lower with EVR+LTac vs MMF+STac (p<0.05). At 12M, mean eGFR was comparable in both treatment regimens regardless of induction therapy (Table).Table: No Caption available.Conclusions: Composite efficacy failure rate was higher in the rATG group but this did not reach statistical significance. Regardless of induction therapy the graft and patient survival was high with EVR+LTac (98.7% & 98.1%) and MMF+STac (96.1% & 98.4%) at 1 year. DISCLOSURES:Vincenti, F.: Grant/Research Support, Novartis, Genzyme, Genentech, Astellas, Alexion, Pfizer. Shihab, F.: Other, Novartis, Consultant and Speaker, Astellas, Consultant. McCague, K.: Employee, Novartis Pharmaceuticals Corporation. Patel, D.: Employee, Novartis Pharmaceuticals Corporation. Mulgaonkar, S.: Grant/Research Support, Novartis, Other, Novartis, Advisor. Shaffer, D.: Grant/Research Support, Novartis.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".