875-P: Baseline Characteristics for FINE-ONE—A Randomized Phase III Trial Assessing Finerenone in People with T1D and CKD
Notice bibliographique
Résumé
Introduction and Objective: CKD occurs in 1 of 3 people with T1D, with substantial loss of kidney function in over half and kidney failure in nearly one fourth. Therapies to reduce these outcomes in T1D are urgently needed. The nonsteroidal mineralocorticoid receptor antagonist finerenone, on top of ACEi/ARB, reduced the risk of kidney and heart outcomes in people with CKD and T2D. The FINE-ONE trial (NCT05901831) will assess the efficacy and safety of finerenone in people with T1D and CKD. Methods: FINE-ONE is an ongoing, global, phase III trial with finerenone. Participants (n=220) with T1D and CKD (UACR ≥200-<5000 mg/g and eGFR ≥25-<90 mL/min/1.73 m2), HbA1c <10%, and serum potassium ≤4.8 mmol/L, on a stable dose of ACEi/ARB, will be randomized 1:1 to finerenone (10 or 20 mg od) or placebo. The primary efficacy outcome is the relative change in UACR from baseline over 6 months (trial duration~7.5 months). Results: At baseline, 176 randomized participants with T1D had mean HbA1c of 7.6%, mean eGFR of 60 mL/min/1.73 m2, median UACR of 536 mg/g, mean age of 51 years, and 38% were female (Table). A high proportion had a history of hypertension (82%) and 21% had CVD. The most common race was White (71%), followed by Asian (19%) and Black (7%). Conclusion: FINE-ONE will determine the efficacy and safety of finerenone in a representative population with T1D and CKD at high risk of progressive kidney function loss. Disclosure 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. A.L. Birkenfeld: None. D. Cherney: Consultant; Boehringer Ingelheim-Lilly, Merck, AstraZeneca, Sanofi, Mitsubishi-Tanabe, Abbvie, Janssen, AMGEN, Bayer, Prometic, BMS, Maze, Gilead, CSL-Behring, Otsuka, Novartis, Youngene, Lexicon, Inversago, GSK. Research Support; Boehringer Ingelheim-Lilly, Merck, Janssen, Sanofi, AstraZeneca, CSL-Behring and Novo-Nordisk, Bayer. H.M. Colhoun: Advisory Panel; Novo Nordisk, Bayer Pharmaceuticals, Inc. Stock/Shareholder; Bayer Pharmaceuticals, Inc. Speaker's Bureau; Medscape. Advisory Panel; Sanofi. Research Support; Sanofi, IQVIA Inc, Roche Diagnostics. Stock/Shareholder; Roche Pharmaceuticals. L. Ji: None. C. Mathieu: Advisory Panel; Novo Nordisk, Sanofi, Eli Lilly and Company, Abbott, Medtronic, SAB Biotherapeutics, Inc, Roche Diabetes Care, Vertex Pharmaceuticals Incorporated, Biomea Fusion, Bayer Pharmaceuticals, Inc. P. Groop: Speaker's Bureau; AstraZeneca, Bayer Pharmaceuticals, Inc, Berlin-Chemie AG, Boehringer-Ingelheim. Advisory Panel; Boehringer-Ingelheim. Speaker's Bureau; Novo Nordisk, Menarini. R.E. Pratley: Consultant; AbbVie Inc. Stock/Shareholder; Altanine, Inc. Consultant; Amgen Inc, AstraZeneca. Other Relationship; Bayer AG, Bayer Pharmaceuticals, Inc, Biomea Fusion. Consultant; Boehringer-Ingelheim. Other Relationship; Carmot Therapeutics, Inc, Corcept Therapeutics, Dompé, Eli Lilly and Company, Endogenex. Consultant; Endogenex. Other Relationship; Fractyl Health, Inc., Gasherbrum Bio, Inc. Consultant; Genprex, Getz Pharma, Hanmi Pharm. Co., Ltd, Intas Pharmaceuticals Ltd, Lexicon Pharmaceuticals, Inc, Lilly USA LLC. Speaker's Bureau; Lilly USA LLC. Other Relationship; Metavention, Novo Nordisk, Novo Nordisk. Speaker's Bureau; Novo Nordisk. Other Relationship; Pfizer Inc, Poxel SA. Consultant; Regeneron Pharmaceuticals. Other Relationship; Sanofi. Consultant; Scholar Rock. Other Relationship; Sun Pharmaceutical Industries Ltd. S. Rosas: Other Relationship; American Diabetes Association. Research Support; Bayer Pharmaceuticals, Inc. Advisory Panel; Bayer Pharmaceuticals, Inc, Sanofi. Research Support; AstraZeneca. 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. J.S. Skyler: Advisory Panel; 4 Immune. Consultant; AbbVie Inc. Advisory Panel; Abvance Therapeutics. Consultant; ActoBiotics. Advisory Panel; ADOCIA. Consultant; AiTA. Board Member; Applied Therapeutics. Advisory Panel; Avotres Inc., Bayer Pharmaceuticals, Inc, Biomea Fusion. Consultant; COUR Pharmaceuticals. Board Member; Dexcom, Inc. Consultant; Eli Lilly and Company. Advisory Panel; Kriya Therapeutics, Levicure. Consultant; Novo Nordisk A/S, Quell Therapeutics. Board Member; SAB Biotherapeutics, Inc. Consultant; Sanofi, Shoreline Biosciences. Advisory Panel; Signos. Consultant; Vertex Pharmaceuticals Incorporated, vTv Therapeutics. Advisory Panel; WiNK. K.R. Tuttle: Consultant; Lilly Diabetes, Boehringer-Ingelheim, Novo Nordisk, Pfizer Inc. Other Relationship; AstraZeneca. Consultant; Bayer Pharmaceuticals, Inc, Traveere Pharmaceuticals, ProKidney. R. Lawatscheck: Employee; Bayer Pharmaceuticals, Inc. M.F. Scheerer: Employee; Bayer Pharmaceuticals, Inc. Stock/Shareholder; Bayer Pharmaceuticals, Inc, Novo Nordisk A/S, AstraZeneca, Eli Lilly and Company. 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. J. Russell: Employee; Bayer Pharmaceuticals, Inc.
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 | 0,001 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,001 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,001 | 0,001 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,002 | 0,003 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,018 | 0,002 |
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 ».