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Kidney Week

Abstract: FR-PO247

Spironolactone for the Prevention of Microalbuminuria in High-Risk Type 2 Diabetes: Results from the Multicenter Randomized Double-Blind Controlled Trial PRIORITY

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Lindhardt, Morten, Steno Diabetes Center Copenhagen, Gentofte, Denmark
  • Tofte, Nete, Steno Diabetes Center Copenhagen, Gentofte, Denmark
  • Frimodt-Moller, Marie, Steno Diabetes Center Copenhagen, Gentofte, Denmark
  • Currie, Gemma, University of Glasgow, Glasgow, United Kingdom
  • Delles, Christian, University of Glasgow, Glasgow, United Kingdom
  • von der Leyen, Heiko E., Hannover Medical School, Hannover, Germany
  • Mischak, Harald, Mosaiques Diagnostics, Sehnde, Germany
  • Rossing, Peter, Steno Diabetes Center Copenhagen, Gentofte, Denmark

Group or Team Name

  • PRIORITY Study Group
Background

The 'Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria trial' (PRIORITY) tested if the aldosterone antagonist spironolactone (25 mg daily) could reduce progression to microalbuminuria in patients with type 2 diabetes (T2D) and normal urinary albumin creatinine ratio (UACR) (< 30 mg/ g) but at high risk for progression based on a urinary proteome-based classifier (CKD273).

Methods

Multicenter randomized double-blind controlled trial. The CKD273 classifier was assessed at baseline in 1775 subjects ; 209 (12 %) had elevated risk and were randomized to spironolactone or matching placebo on top of ongoing treatment. Primary endpoint was development of confirmed microalbuminuria (moderate albuminuria) in 2 of 3 first morning urine samples (UACR) >30 mg/g and ≥30 % increase from baseline).

Results

Baseline mean ± SD: Age 63 ± 6.4 years, blood pressure 135 ± 12/ 79 ± 9 mmHg, eGFR 81 ± 17 ml/min/1.73m2, and UACR 9.1 ± 7 mg/g, 88 % on ACEi or ARB. Mean follow up time was 2.5 years from 7 days to 4.3 years. Development of persistent microalbuminuria was seen in 35 (33 %) of placebo and 26 (26 %) spironolactone treated subjects, hazard ratio (HR) 0.81 (CI 95%: 0.49-1.34) p=0.41. In total 58 (28 %) did not complete the full follow up period, of which 16 had suspected side effects or safety considerations. Hyperkalemia was seen in 4 vs 13 and gynecomastia in 0 vs 3 subjects on placebo vs spironolactone, respectively, and 28 were excluded due to lack of adherence or lost to follow up. In 151 subjects treated per protocol HR was 0.71 (CI 95 %: 0.40 – 1.25) p = 0.23.

Conclusion

Treatment with spironolactone was not able to prevent or delay progression to persistent microalbuminuria in normoalbuminuric subjects with type 2 diabetes and high risk of kidney disease based on urinary proteomics risk score CKD273.

Funding

  • Government Support - Non-U.S.