DNlite™ Assay Demonstrates Independent Renal Risk Prediction in Landmark CREDENCE Trial Analysis
核心洞察
A new analysis from the CREDENCE trial shows DNlite™ independently predicts adverse renal outcomes beyond albuminuria and eGFR in type 2 diabetes (搜索) patients with chronic kidney disease (搜索).
The assay measures urinary post-translationally modified Fetuin-A (uPTM-FetA (搜索)), a novel biomarker reflecting kidney stress biology not captured by conventional renal markers.
Findings were consistent across both placebo and canagliflozin treatment arms, with renal risk increasing progressively across uPTM-FetA (搜索) tertiles and quartiles.
A new analysis from the landmark CREDENCE trial, presented as a Late-Breaking Abstract at the American Diabetes Association (ADA) 86th Scientific Sessions, demonstrates that the DNlite™ assay independently predicts adverse renal outcomes beyond conventional renal biomarkers in patients with type 2 diabetes (搜索) and chronic kidney disease (搜索) (CKD). The findings, announced by Bio Preventive Medicine Corp. (搜索) and Precision Diabetes, Inc. (搜索), suggest the assay may help identify patients at persistently elevated renal risk earlier in the disease process.
The analysis evaluated baseline DNlite™ assay results in 2,429 participants from the CREDENCE trial, including both placebo-treated and canagliflozin-treated participants. CREDENCE was a landmark international renal outcomes trial that helped establish SGLT2 inhibitors as a foundational therapy for diabetic kidney disease (搜索).
A Novel Biomarker for Kidney Stress
DNlite™ measures urinary post-translationally modified Fetuin-A (uPTM-FetA (搜索)), a biomarker associated with kidney stress, inflammation, metabolic dysregulation, and progressive renal injury. The assay is designed to help identify patients with diabetic kidney disease (搜索) who may remain at elevated risk for progression beyond what is fully captured by conventional renal biomarkers alone.
Despite major therapeutic advances, many patients with type 2 diabetes (搜索) and CKD continue to experience progressive renal decline and remain difficult to risk stratify using conventional clinical measures alone. The new analysis suggests the DNlite™ assay may address this unmet need by providing prognostic information beyond traditional renal markers including urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR).
Key Findings Across Treatment Arms
The analysis yielded several notable findings. DNlite™ independently predicted adverse renal outcomes after multivariable adjustment, and renal risk increased progressively across uPTM-FetA (搜索) tertiles and quartiles. Kaplan–Meier analyses demonstrated significant risk stratification across both placebo and treatment arms, indicating the biomarker's prognostic value was consistent regardless of SGLT2 inhibitor therapy.
"DNlite™ reflects a unique aspect of kidney stress biology that is not fully captured by traditional renal markers alone," said Karen Tseng, CEO of Bio Preventive Medicine Corp. (搜索) "The consistency of these findings across both untreated and treated populations strengthens our confidence in the clinical relevance of this biomarker platform."
Addressing Residual Renal Risk
The findings carry particular significance given that residual renal risk remains a major challenge even in the era of SGLT2 inhibitor therapy. "Residual renal risk remains a major challenge in patients with type 2 diabetes (搜索) and CKD, even in the era of SGLT2 inhibitor therapy," said Ele Ferrannini, Emeritus Investigator of the National Research Institute of Clinical Physiology. "This analysis demonstrates that the DNlite assay provides independent prognostic information beyond conventional clinical parameters and may help refine renal risk assessment in this population."
The companies believe the DNlite™ assay represents a promising next-generation biomarker approach for improving early diabetic kidney disease (搜索) risk stratification and identifying residual renal risk in high-risk patients.
Professor Ele Ferrannini, a renowned leader in diabetes and metabolic disease research and senior author on the study, passed away shortly before the presentation of these findings at the ADA Scientific Sessions. Precision Diabetes and Bio Preventive Medicine are honored to recognize his longstanding scientific contributions and collaboration on this work.
Bio Preventive Medicine Corp. (搜索), based in Zhubei City, Taiwan, is a clinical-stage biotechnology company focused on advancing precision diagnostics for kidney disease and chronic metabolic disorders. Precision Diabetes, Inc. (搜索), headquartered in Raleigh, North Carolina, is an emerging leader in enabling precision medicine for diabetes through novel diabetes biomarkers and algorithms.