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Abstract: TH-PO252

An Interim Analysis of Clinical and Histopathological Results of the Transformative Research in Diabetic Nephropathy (TRIDENT) Study

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Mohandes, Samer, University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Abedini, Amin, University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • AL-Obaidi, Mustafa, University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Devalaraja-Narashimha, Kishor B., Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Morton, Lori, Regeneron Pharmaceuticals Inc, Tarrytown, New York, United States
  • Liles, John T., Gilead Sciences Inc, Foster City, California, United States
  • Hu, Erding, GlaxoSmithKline USA, Philadelphia, Pennsylvania, United States
  • Sarov-Blat, Lea, GlaxoSmithKline USA, Philadelphia, Pennsylvania, United States
  • Kalra, Gurmannat, GlaxoSmithKline USA, Philadelphia, Pennsylvania, United States
  • Guarnieri, Paolo, Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, Connecticut, United States
  • Karihaloo, Anil K., Novo Nordisk Inc, Plainsboro, New Jersey, United States
  • Palmer, Matthew, University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Susztak, Katalin, University of Pennsylvania, Philadelphia, Pennsylvania, United States
Background

The incidence of Diabetic Kidney Disease (DKD) continues to grow and remains a significant health burden. DKD presents with variable speed of decline in kidney function with little reliable indicators or understanding of underlying mechanisms. The TRIDENT study is a multicenter, prospective, observational study of patients with Diabetes mellitus undergoing a clinically indicated kidney biopsy with a goal to further understand the underlying mechanisms. Herein, we report an interim analysis of available results.

Methods

Subjects with DM undergoing clinically indicated kidney biopsy at 19 medical centers were eligible. Extra kidney biopsy core was obtained for the study. Histological lesions were scored by a single pathologist. Baseline characteristics were obtained at the time of enrollment. Follow up visits were scheduled every 6 months for 18 months and monitoring up to 4 years.

Results

We consented 412 subjects and obtained kidney tissue samples for 330 subjects. We did not encounter any major biopsy related adverse event. Using histological criteria 146 subjects had DKD. Baseline characteristics obtained include Age (mean 54 years), Gender (Male 55%), Race (White 52.3%, black 37.4%), DM type (90.6% type 2), BMI (mean 32.8 kg/m2), presence of hypertension (94.8% present), smoking (57%). The enrollment GFR ranged (4-123 ml/min/1.73 m2) baseline urine protein to creatinine ratio (UPCR) ranged (0-22 g/g). We observed that baseline GFR showed a significant but weak negative correlation with Interstitial fibrosis, intimal fibrosis and mesangial hyaline. Baseline UPCR correlated with insudative lesions, epithelial hyperplasia, interstitial fibrosis and foot process effacement. Patients with fast progression (average decrease of GFR >5 ml/min/1.73m2/year) had higher baseline HbA1c, baseline UPCR, arteriolar hyalinosis, foot process effacement, microvillous transformation and RPS class.

Conclusion

This interim analysis demonstrates the importance of histological analysis to determine kidney function decline in DKD.

Funding

  • Commercial Support