Real-World Associations of KidneyIntelX Risk Stratification With Guideline-Directed Therapy, Kidney Outcomes, and Metabolic Trajectories in Early Diabetic Kidney Disease.

BACKGROUND

KidneyIntelX is a prognostic blood test for the progression of diabetic kidney disease (DKD) within 5 years. Long-term utility is important.

MATERIALS AND

METHODS

Adults with type 2 diabetes (T2D) and CKD (G1-G3b) from two medical centres were assessed for the following: (1) baseline KidneyIntelX risk levels and their association with GDMT usage; (2) changes in temporal kidney and metabolic trajectories after testing; (3) probability for a kidney composite outcome of sustained eGFR decline of 40% or kidney failure by baseline KidneyIntelX risk strata; and (4) risk at 12-month for repeat-tested participants.

RESULTS

2470 patients with T2D and CKD (median baseline eGFR 63 mL/min/1.73 m2, UACR 51 mg/g, and HbA1c 7.2%), KidneyIntelX risk was 49.9% low, 40.6% intermediate, and 9.5% high. SGLT2i usage post-test increased to 56%, 45%, 34% in high, intermediate, low-risk groups. SGLT2i combined with GLP-1 increased to 32%, 25%, 17% per risk group. Improvements in eGFR slope (-4.6 to -2.6 mL/min/1.73 m2/year), UACR (relative decrease of 23%), and HbA1c (relative decrease of 7.6%) were greatest in the high-risk group. Hazard ratio (HR) for DKD progression for high vs. low was 10.4 [4.4-24.8] and intermediate vs. low HR was 4.0 [2.0-8.7]. With repeat testing (n = 1143), 29% transitioned to lower risk accompanied by biomarker reductions, specifically KIM-1, and initiation of SGLT2i or GLP-1 doubled odds of risk reduction.

CONCLUSIONS

KidneyIntelX was associated with targeted GDMT usage with favourable changes in kidney and metabolic clinical measures and risk trajectories, with lower risk linked to therapy initiation and reduction in biomarkers.