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Kidney Week

Abstract: TH-PO443

Design and Patient Characteristics of a Study to Assess the Renoprotective Effects of the SGLT2 Inhibitor Dapagliflozin in Non-Diabetic Proteinuric Kidney Disease (DIAMOND)

Session Information

Category: CKD (Non-Dialysis)

  • 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Dekkers, Claire, University Medical Center Groningen, Groningen, Netherlands
  • Cherney, David, University Health Network, Toronto, Ontario, Canada
  • Reich, Heather N., Toronto General Hospital, Toronto, Ontario, Canada
  • Barbour, Sean, University of British Columbia, Vancouver, British Columbia, Canada
  • Abdul gafor, Abdul halim, University Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia
  • Lim, Soo Kun, Univeristy Malaya Medical Centre, Kuala Lumpur, Malaysia
  • Wong, Muh Geot, The George Institute for Global Health, Sydney, New South Wales, Australia
  • Laverman, Gozewijn Dirk, ZGT Almelo, Almelo, OVERIJSSEL, Netherlands
  • Vervloet, Marc G., Amsterdam University Medical Center, Overveen, Netherlands
  • Gansevoort, Ron T., University Medical Center Groningen, Groningen, Netherlands
  • L Heerspink, Hiddo Jan, University Medical Center Groningen, Groningen, Netherlands
Background

Sodium glucose co-transporter 2 (SGLT2) inhibition decreases albuminuria and reduces the risk of kidney disease progression in patients with type 2 diabetes. These beneficial effects are likely mediated by activation of tubuloglomerular feedback by natriuresis, leading to decreased intraglomerular hypertension. Since non-diabetic kidney diseases are also characterized by glomerular hypertension, we tested the hypothesis that in patients with non-diabetic proteinuric kidney disease, SGLT2 inhibition with dapagliflozin reduces proteinuria and acutely and reversibly reduces glomerular filtration rate (GFR).

Methods

We designed a multicenter double-blind randomized placebo controlled 6-week cross-over study to assess the change from baseline in 24-hour proteinuria with dapagliflozin 10 mg/day in patients with proteinuric kidney disease without diabetes (ClinicalTrials.gov identifier: NCT03190694). The secondary endpoint was the change in iohexol-derived GFR. The main inclusion criteria were: urinary protein excretion >500 mg/24hr and ≤3500 mg/24hour, eGFR ≥25 mL/min/1.73m2; stable dose of RAAS inhibitors.

Results

Patients with non-diabetic kidney disease were enrolled between November 2017 and April 2019. A total of 58 patients were screened of whom 53 patients were randomized in this ongoing study. The mean age at screening was 51 (SD 13) years and 32% were female. Mean screening eGFR was 59 (29) ml/min/1.73m2 and median proteinuria 1074 (25th to 75th Percentile 810 -1400) mg/24hr. Overall, blood pressure was well controlled (SBP/DBP 128 (15) /78 (8) mmHg) and mean body weight was 83.0 (20) kg. Mean HbA1c was 5.6 (0.4) % and mean hemoglobin level 138 (20) g/L. All patients were using a RAAS inhibitor.

Conclusion

This is the first placebo controlled clinical trial to examine the effects of an SGLT2 inhibitor in a non-diabetic population at risk for progressive kidney function loss. Final study results are expected in December 2019.

Funding

  • Commercial Support