1863-LB: The Confidence Trial—Efficacy/Safety of Combining Finerenone with Empagliflozin in People with Chronic Kidney Disease and Type 2 Diabetes
Notice bibliographique
Résumé
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.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction machine sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Le volet Gemma est une étiquette directe du modèle pour chaque travail de la base, lue sur la notice réduite au titre. Le volet Codex est un classifieur appris des 10 348 étiquettes directes de Codex et calibré sur les taux pondérés de l'échantillon; les champs sans appui suffisant ne portent aucun appel Codex. Le mode candidate est l'union des deux volets; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont pas des étiquettes humaines.
Scores du classifieur distillé par catégorie (deux têtes)
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,003 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,002 | 0,002 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,001 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,001 |
| Intégrité de la recherche | 0,002 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,011 | 0,001 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule source (Gemma direct ou Codex distillé), pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».