875-P: Baseline Characteristics for FINE-ONE—A Randomized Phase III Trial Assessing Finerenone in People with T1D and CKD
Bibliographic record
Abstract
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.
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.018 | 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".