The PRIME-CKD project reports new findings on the predictive value of urinary Clusterin (uCLU) for kidney disease progression and response to the Endothelin Receptor Antagonist Atrasentan in patients with type 2 diabetes and chronic kidney disease.

In the SONAR trial it was found that atrasentan improves kidney outcomes for patients with type 2 diabetes and chronic kidney disease. But this trial also showed  variable response to atrasentan for individual patients.

PRIME-CKD aims to identify, validate and implement biomarkers for kidney disease progression and thus improve the treatment response of individual patients to drugs that enhance kidney outcomes into clinical practice. A detailed proteomics study by PRIME-CKD to find molecular biomarkers of atrasentan response in the SONAR trial showed that urinary Clusterin is a top candidate biomarker.

Researchers from the University of Michigan, Lund University and the University Medical Center Groningen have just published these recent findings in Nature Communications in a paper entitled Urinary Clusterin as a Biomarker of Human Kidney Disease Progression and Response to the Endothelin Receptor Antagonist Atrasentan: An Exploratory Analysis from the SONAR Trail.

Dr. Wenjun Ju (University of Michigan) says: “With this study we have further supported the potential of urinary Clusterin as an important biomarker that can inform us better about the kidney disease progression of individual patients and how they respond to atrasentan, a drug currently in development for the treatment of IgA nephropathy. The credit for these results goes to the entire BEAt-DKD and PRIME-CKD consortia, associates, and stakeholders for years of hard work and support!”

Professor Mathias Kretzler (University of Michigan) adds: “We have clearly shown that urinary Clusterin is associated with kidney disease progression and response to atrasentan treatment, supporting its potential as a pharmacodynamic biomarker to target therapy. This is such an important outcome in our ongoing efforts to enable a more personalized treatment of people who suffer from chronic kidney disease.”

What this may mean in practice
Personalized medicine could help kidney patients to receive effective therapy sooner. By implementing biomarker-guided therapy, clinicians may prevent avoidable kidney disease progression and reduce the likelihood of severe complications such as dialysis.

For healthcare systems, biomarker-guided therapy has the potential to improve treatment efficiency by focusing resources on therapies that offer measurable benefit. This could support future decision-making for reimbursement, guideline development and long-term kidney-health strategies.

PRIME-CKD 17/02/2026