Design of START: A Phase 2 Study Evaluating the Safety and Efficacy of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing Cardiac Surgery
Bibliographic record
Abstract
Background: Cardiac surgery is associated with an increased risk of acute kidney injury (AKI). RBT-1 induces non-ischemic tissue preconditioning that has shown organ protective effects in several animal models of AKI. Markers of cytoprotection observed with RBT-1 treatment in animals were also found to be upregulated in a Phase 1 study of RBT-1 in healthy volunteers and subjects with Stages 3 and 4 chronic kidney disease (CKD). Based on these data, we have designed a Phase 2, placebo-controlled, double-blind, randomized, multicenter study that will assess the effect of RBT-1 on preconditioning response biomarkers in subjects scheduled to undergo cardiac surgery Methods: Study Design: This study will enroll 126 subjects scheduled to undergo coronary artery bypass graft (CABG) and/or cardiac valve surgery. Eligible subjects will be randomized to receive a single dose of RBT-1 or placebo via intravenous infusion between 24 and 48 hours prior to scheduled cardiac surgery. Subjects will be followed through Day 90. Inclusion/Exclusion Criteria: Subjects eligible for enrollment include adults who are scheduled to undergo non-emergent, on-pump coronary artery and/or cardiac valve surgery. Major exclusion criteria include CKD with eGFR ≤20 ml/min/1.73m2 or need for dialysis. Results: Objectives: The primary objective of this study is to evaluate the efficacy of RBT-1 on preconditioning response biomarkers from baseline through Day 3 post-cardiac surgery. Based on preclinical data, plasma heme oxygenase-1 [HO-1], ferritin, and interleukin-10 [IL-10]) have been identified as the relevant biomarkers for this study. Secondary objectives include change in tubular injury biomarkers and incidence of AKI based on KDIGO classification. Exploratory objectives include the occurrence of major adverse kidney events (MAKE) through Days 30 and 90. Conclusions: The multinational START study will assess the cytoprotective preconditioning response to RBT-1 in subjects undergoing cardiac surgery. Funding: Commercial Support - Renibus Therapeutics
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.003 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.010 | 0.002 |
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 source (direct Gemma or distilled Codex), 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".