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Kidney Week

Abstract: PO0747

KidneyIntelX as an Enrichment Tool for Clinical Trials in Early Diabetic Kidney Disease

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Vasquez-Rios, George, Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Nadkarni, Girish N., Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Neal, Bruce, University of New South Wales, Sydney, New South Wales, Australia
  • Mahaffey, Kenneth W., Stanford University, Stanford, California, United States
  • Hansen, Michael K., Janssen Research and Development LLC, Raritan, New Jersey, United States
  • Fleming, Fergus, Renalytix, New York, New York, United States
  • L Heerspink, Hiddo Jan, Rijksuniversiteit Groningen, Groningen, Groningen, Netherlands
  • Coca, Steven G., Icahn School of Medicine at Mount Sinai, New York, New York, United States
Background

Clinical trials in nephrology are often enriched for patients with high levels of albuminuria to increase event rates. KidneyIntelX is a composite risk score that incorporates plasma biomarkers and clinical data to predict progression of diabetic kidney disease. We sought to assess the value of KidneyIntelX for future clinical trials in patients with type 2 diabetes and normo- or microalbuminuria.

Methods

Plasma TNFR-1, TNFR-2, and KIM-1 were measured on the Renalytix KidneyIntelX platform in participants in the CANVAS trial with UACR <300 mg/g (n=3277). A logistic regression model incorporating the 3 biomarkers and clinical variables was applied to obtain the predicted probabilities for a composite kidney outcome of eGFR decline ≥5 ml/min/1.73 m2, sustained 40% eGFR decline, or kidney failure. We assessed the potential utility of KidneyIntelX for enrichment in a hypothetical trial using BioPET (http://prognosticenrichment.com).

Results

176 kidney outcomes occurred over a median of 6.1 years follow-up (5.6% incidence). The composite kidney endpoint occurred in 0.6% in the 1st decile and increased to 16.8% in the 10th decile of KidneyIntelX risk strata (Figure 1a). Application of an enrollment threshold at the top 20%-25% of KidneyIntelX score, assuming a 40% RRR of therapy, alpha 0.05, $1000 for screening and $50,000 for full trial run-through, would reduce the sample size needed by approximately 39-43%, and reduce trial costs by 53-57% (Figure 1b).

Conclusion

The KidneyIntelX platform facilitated a significant enrichment of kidney events in CANVAS participants that are typically excluded from kidney-specific randomized controlled trials due to low levels of albuminuria. KidneyIntelX has the potential to be an effective tool for trial enrichment.

Funding

  • Commercial Support