Overview

Comparison Between the Efficacy of SGLT2 Inhibitor Therapy Versus ACE Inhibitor in the Treatment of Diabetic Kidney Disease

Status:
Not yet recruiting

Trial end date:
2024-05-01

Target enrollment:

Participant gender:

Summary

Diabetes is the leading cause of chronic kidney disease (CKD) and end-stage kidney disease worldwide. Diabetic kidney disease (DKD) is a clinical diagnosis based upon the presence of reduced glomerular filtration rate (GFR) and/or increased urinary albumin excretion (UACR) in diabetes. The inhibition of the renin-angiotensin system (RAS) has been identified as the cornerstone in the management of DKD for decades. Recently, more evidence supports the use of Sodium-glucose cotransporter 2 inhibitors (SGLT2i) in the treatment of DKD. They were associated with slower progression of renal disease and lower rates of clinically relevant kidney events. Those studies confirmed the SGLT2i efficacy in kidney protection and showed that their addition to angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBS) will be more effective than using ACEi or ARBS alone. It is unclear whether SGLT2i is used as a first-line instead of ACEi or ARB, and to what extent it will be effective in managing DKD compared to the proven effect of ACEi/ARBs alone. This study provides a unique opportunity to address this gap in the literature. The aim of this study is to compare, head to head, the renal performance of ACEi (standard of care) versus SGLT2 in diabetic patients who have evidence of deteriorating renal function evidenced by either the reduction of e GFR or increased UACR. Scientific hypotheses: Null hypothesis: after one year, the mean change of the e GFR in the enalapril group - Mean change of the e GFR in the empagliflozin group > or = 5 ml/min/1.73m2 Alternative hypothesis: after one year, the mean change of the e GFR in the enalapril group - Mean change of the e GFR in the empagliflozin group < 5 ml/min/1.73m2

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

Omar Tarek Elfarargi

Treatments:

Empagliflozin
Enalapril
Enalaprilat