1863-LB: The Confidence Trial—Efficacy/Safety of Combining Finerenone with Empagliflozin in People with Chronic Kidney Disease and Type 2 Diabetes
Bibliographic record
Abstract
Introduction and Objective: Several drugs reduce the risk of chronic kidney disease (CKD) progression and cardiovascular events in people with CKD and type 2 diabetes (T2D), including the selective non-steroidal mineralocorticoid receptor antagonist, finerenone, and sodium-glucose cotransporter 2 inhibitors (SGLT2is). However, it remains unclear if these drugs should be sequentially or simultaneously initiated in individuals with CKD and T2D. Methods: CONFIDENCE is a randomized, controlled, double-blind, double-dummy, global, multicenter, clinical trial in adults with CKD, defined as having an estimated glomerular filtration rate (eGFR) of 30 to 90 mL/min/1.73 m2 and 100 ≤UACR <5000 mg/g, and T2D. Participants were randomized 1:1:1 to once daily 10 or 20 mg finerenone plus placebo, 10 mg empagliflozin plus placebo, or 10 or 20 mg finerenone plus 10 mg empagliflozin. The primary efficacy endpoint is the relative change in UACR from baseline at Day 180. Secondary endpoints include the proportion of individuals achieving a reduction in UACR >30% from baseline to Day 180, the incidence of hyperkalemia and acute kidney injury, and the assessment of initial and longer-term changes in eGFR. Results: There were 818 participants randomized across 14 countries between July 2022 and August 2024. Mean eGFR (ml/min/1.73 m2 [SD]) was 54.2 (17.1). Median UACR (mg/g [IQR]) was 583 (292, 1140). Mean HbA1c (% [SD]) was 7.3 (1.2). Mean systolic/diastolic BP (mmHg) was 135.2/77.3. GLP-1 RAs and insulin were used by 182 (23%) and 313 (39%) participants, respectively. Conclusion: CONFIDENCE will determine the efficacy and safety of finerenone and empagliflozin combination therapy compared with either agent alone in people with CKD and T2D. Data will be available and we intend to present the primary results at ERA, we will present additional endpoints and subgroups of interest. Disclosure R. Agarwal: Consultant; Bayer Pharmaceuticals, Inc, Boehringer-Ingelheim, Novartis Pharmaceuticals Corporation. Other Relationship; Vertex Pharmaceuticals Incorporated, Chinook Therapeutics, Inc, UpToDate. Consultant; Vera Therapeutics, Akebia. J.B. Green: Consultant; BI Lilly NovoNordisk Bayer Anji Vertex Valo Mineralys AstraZeneca. Research Support; BI Lilly Merck Bluedrop Roche. H.L. Heerspink: Consultant; Alnylam Pharmaceuticals, Inc, Alexion Pharmaceuticals, Inc, AstraZeneca, Bayer Pharmaceuticals, Inc, Boehringer-Ingelheim, Eli Lilly and Company, Janssen Pharmaceuticals, Inc, Novartis AG, Novo Nordisk A/S, Roche Pharmaceuticals, Traveere Pharmaceuticals, Menarini. J.F. Mann: Other Relationship; AstraZeneca, Bayer Pharmaceuticals, Inc. Advisory Panel; Novo Nordisk. Board Member; AstraZeneca, Bayer Pharmaceuticals, Inc, Boehringer-Ingelheim, Novo Nordisk. Other Relationship; Sanofi. Consultant; AstraZeneca, Bayer Pharmaceuticals, Inc, Novo Nordisk. Research Support; AstraZeneca. Other Relationship; Boehringer-Ingelheim. Research Support; Novo Nordisk, Sanofi. Speaker's Bureau; AstraZeneca, Bayer Pharmaceuticals, Inc, Novo Nordisk, Novartis AG. Other Relationship; UpToDate Inc / KDIGO. J.B. McGill: Advisory Panel; Bayer Pharmaceuticals, Inc. Consultant; Jaeb Center for Health Research. Advisory Panel; Boehringer-Ingelheim, Lilly Diabetes, Novo Nordisk, MannKind Corporation. Research Support; Diagnode, Lexicon Pharmaceuticals, Inc, Biomea Fusion. A.K. Mottl: Research Support; Alexion Pharmaceuticals, Inc, Bayer Pharmaceuticals, Inc. Advisory Panel; Bayer Pharmaceuticals, Inc, Vera Therapeutics. Research Support; Novartis Pharmaceuticals Corporation. Advisory Panel; Novartis Pharmaceuticals Corporation. Other Relationship; Novo Nordisk, UpToDate. J. Rosenstock: Advisory Panel; Amgen Inc. Research Support; Amgen Inc. Advisory Panel; Applied Therapeutics. Research Support; Applied Therapeutics, AstraZeneca. Advisory Panel; Bayer Pharmaceuticals, Inc, Biomea Fusion, Corcept Therapeutics, Eli Lilly and Company. Research Support; Eli Lilly and Company. Advisory Panel; Hanmi Pharm. Co., Ltd. Research Support; Merck & Co., Inc, Novartis AG. Advisory Panel; Novo Nordisk. Research Support; Novo Nordisk, Pfizer Inc. Advisory Panel; Regeneron Pharmaceuticals. Research Support; Regeneron Pharmaceuticals, Regeneron Pharmaceuticals. Advisory Panel; Regor Therapeutics, Roche Pharmaceuticals, Sanofi. Research Support; Sanofi. Advisory Panel; Structure Therapeutics, Inc, Zealand Pharma A/S. P. Rossing: Speaker's Bureau; Abbott. Advisory Panel; AstraZeneca, Bayer Pharmaceuticals, Inc, Boehringer-Ingelheim, Gilead Sciences, Inc, Novo Nordisk. Other Relationship; Lexicon Pharmaceuticals, Inc. Speaker's Bureau; Daiichi Sankyo. M. Vaduganathan: Advisory Panel; American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, BMS, Boehringer Ingelheim, Chiesi, Cytokinetics, Fresenius Medical Care, Idorsia Pharmaceuticals, Lexicon Pharmaceuticals, Merck, Mile, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi, and Tricog Health. Research Support; AstraZeneca, Galmed, Novartis, Bayer AG, Occlutech, and Impulse Dynamics. M. Brinker: Employee; Bayer AG. Stock/Shareholder; Bayer AG. C. Scott: Employee; Bayer Pharmaceuticals, Inc. L. Li: Employee; Bayer Pharmaceuticals, Inc. K. Rohwedder: Employee; Bayer Pharmaceuticals, Inc. M. Nangaku: Other Relationship; Astellas Pharma Inc, AstraZeneca, Daiichi Sankyo, GlaxoSmithKline plc, Daiichi Sankyo, Kyowa Kirin Co., Ltd, Boehringer-Ingelheim. Consultant; Novo Nordisk. Research Support; Bayer Pharmaceuticals, Inc. Other Relationship; Mitsubishi Tanabe Pharma Corporation. Funding This work was supported by Bayer AG, who funded the CONFIDENCE study.
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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) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.011 | 0.001 |
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".