POINTER: A Phase 2b, Randomized, Placebo-Controlled, Double-Blind Dose-Finding Clinical Study of RMC-035 in Participants at High Risk for Kidney Injury Following Cardiac Surgery
Bibliographic record
Abstract
Background: Cardiac surgery with cardiopulmonary bypass (CPB) carries risks such as AKI and CKD progression. In the Phase 2a AKITA study, RMC-035, an alpha-1-microglobulin analogue, showed potential for kidney protection. The POINTER study assessed its dose effect on preserving postoperative renal function. Methods: Patients with eGFR ≥30 mL/min/1.73m2 undergoing non-emergent cardiac surgery with CPB were randomized (stratified by eGFR <60 vs ≥60 mL/min) to placebo, 30 mg, or 60 mg RMC-035 (3:2:2) and followed for 90 days. The primary endpoint was absolute eGFR change from baseline; the key secondary endpoint was major adverse kidney events (MAKE) at Day 90. Additional endpoints included MAKE at Day 60 and AKI at Day 4. Safety was evaluated via adverse events and labs. Results: 170 subjects were randomized and treated with study drug at 19 cardiac surgery centers in Canada, Czech Republic, Germany, and Spain. Patients were predominantly white (n=165), and male (n=123) with a mean age of 70.9 years. Mean baseline eGFR was 74.2 mL/min/1.73m2 with a majority of patients (n=120) in the ≥60 mL/min stratum. Key efficacy and safety results are expected by the end of October 2025. Conclusion: The results will provide critical evidence of RMC-035’s kidney-protective potential in cardiac surgery patients at high risk of renal injury. As a first-in-class candidate, it may offer a novel treatment option in an area of high unmet need. Findings will inform optimal dosing and benefit-risk assessment for a future pivotal Phase 3 trial. Funding: Commercial Support - Guard Therapeutics International ABPOINTER - Key Demographics and Baseline Characteristics [N=170]
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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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.004 |
| Insufficient payload (model declined to judge) | 0.014 | 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".