The CKD Biomarkers Consortium (CKD BioCon) was established to pursue the discovery and validation of novel biomarkers for chronic kidney disease (CKD). The consortium consists of investigators who specialize in clinical nephrology, epidemiology, molecular biology, genomics, proteomics, metabolomics, systems biology, laboratory medicine, biostatistics, and laboratory test verification and qualification. Studies conducted by CKD BioCon assayed specimens and analyzed data from various epidemiological studies of participants with kidney disease or at risk for developing kidney disease. These NIH-funded studies include AASK, MDRD, ARIC, CRIC, CKiD, REGARDS, MESA cohorts, and more. Specific aims vary by study, but include identifying and evaluating biomarkers of CKD incidence, cardiovascular events, changes in kidney histology, and disease progression and outcomes. The development and validation of biomarkers that result from these studies aid in the identification of high-risk patients and inform clinical practices for monitoring and treatment of CKD.

The primary objectives are 1) to discover new biomarkers using state-of-the-art laboratory methods, 2) to validate biomarkers described in the literature and those discovered de novo with respect to the ability to predict incidence and progression of CKD and assess the level of kidney function, and 3) to collect data needed to seek approval from the Food and Drug Administration (FDA) for any new panel of biomarkers that, based on steps above, are likely to be 'cleared' or to 'qualify' as having clinical utility ('fit for purpose'), and to establish their cost-effectiveness compared to standard approaches.

Secondary objectives are 1) to catalog the study populations and associated specimens from epidemiological studies to assess their suitability for biomarker discovery and validation regarding incidence and progression of CKD and assessment of kidney function (GFR), 2) to assess the performance of newly discovered and previously known promising biomarkers in specimens collected and stored under different conditions, and 3) to provide information generated by BioCon to the NIDDK Central Repository to make it accessible to the larger scientific community.

Outcome measures differ based on the individual cohorts. Outcomes of interest include CKD progression (eGFR decline and/or ESKD), mortality, and cardiovascular disease (myocardial infarction, heart failure, stroke, atrial fibrillation, and peripheral arterial disease).

For inclusion criteria, please refer to individual cohort descriptions.

For exclusion criteria, please refer to individual cohort descriptions.

Between 2018 and 2025, CKD BioCon has advanced the understanding of CKD progression through large-scale, multi-cohort studies focused on novel blood and urine biomarkers. Using metabolomics, researchers identified plasma metabolites—such as pseudouridine and homocitrulline—that consistently predicted CKD progression across diverse populations. Using high-throughput SomaScan proteomics platforms, investigators measured millions of protein signals in over 3,000 CKD participants. They identified numerous novel plasma markers associated with CKD progression, and developed a 65-protein risk score that robustly predicted 10-year progression. Investigators also identified several plasma markers associated with cardiovascular events and derived a 32-protein risk score for major cardiovascular events. Urinary markers of tubular injury, including KIM-1, MCP-1, TNFR1, and TNRF2, were shown to improve risk stratification beyond traditional measures like eGFR and albuminuria. In pediatric CKD, metabolomic signatures linked to dietary intake provided insight into early risk factors, while efforts to refine kidney function estimation led to the identification of novel endogenous filtration markers. Together, these findings support a precision medicine approach to CKD, emphasizing the potential of integrated biomarker panels to improve early detection, prognosis, and individualized treatment.