Table 1.
Recent chronic kidney disease randomized clinical trials of SGLT2is and selective nonsteroidal mineralocorticoid receptor antagonist
| Trial name | Intervention | Population size | Target population | Primary endpoint | Secondary endpoint | Median follow-up | Results |
|---|---|---|---|---|---|---|---|
| EMPA-REG [22] | Empagliflozin 10 mg daily or 25 mg daily vs placebo | 7020 | Type II diabetic patients with established CV disease and eGFR > 30 mL/min/1.73 m2 with body mass index < 45 and HgA1c 7–9% | Composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke | Renal outcomes: Progression to macroalbuminuria, doubling serum creatinine, renal replacement therapy or death from renal disease | 3.1 years |
- Primary endpoint: 14% lower in canagliflozin group (hazard ratio, 0.86; 95.02% CI, 0.74 to 0.99) - Secondary endpoint: 39% lower in empagliflozin group (hazard ratio, 0.61; 95% CI, 0.53 to 0.70) |
| CREDENCE [23] |
All patients on RAAS blockade agent Canagliflozin 100 mg daily s placebo |
4401 | Type II diabetic patients with eGFR 30–89 mL/min/1.73 m2 and urine albumin/creatinine ratio between > 300 and 5000 mg/g | Composite of end-stage kidney disease, doubling of serum creatinine, or kidney/cardiovascular-related death | Composite of cardiovascular death, myocardial infarction, stroke, and hospitalization for heart failure | 2.62 years |
- Primary endpoint: 30% lower in canagliflozin group (hazard ratio, 0.70; 95% CI, 0.59 to 0.82) - Secondary endpoint: 39% lower in canagliflozin group (hazard ratio, 0.61; 95% CI, 0.47 to 0.80) |
| DAPA-CKD [21] |
All patients on RAAS blockade agent for at least four weeks Dapagliflozin 10 mg daily vs placebo |
4304 |
eGFR between 25 and 75 mL/min/1.73 m2 and urinary albumin-to-creatinine ratio of 200 to 5000 mg/g 67% of patients had diabetes mellitus type 2 |
Composite of sustained decline in eGFR of at least 50%, end-stage kidney disease, or death from kidney or cardiovascular causes | Composite of death from cardiovascular causes or hospitalization for heart failure | 2.4 years |
- Primary endpoint: 39% lower in the dapagliflozin group (hazard ratio, 0.61; 95% CI, 0.51 to 0.72) - Primary endpoint in DKD participants: 36% lower in dapagliflozin group (hazard ratio 0.64; 95% CI, 0.52 to 0.79) - Primary endpoint in CKD without diabetes: 50% lower in dapagliflozin group (hazard ratio 0.50 95% CI, 0.35 to 0.72) - Secondary endpoint: 29% lower in dapagliflozin group (hazard ratio 0.71 (95% CI, 0.55 to 0.92) |
| FIDELIO-DKD [24] |
All patients on maximally tolerated RAAS blockade agent Finerenone 10 to 20 mg daily vs placebo |
5734 | DKD patients with either urinary albumin-to-creatinine ratio of 30 to less than 300 mg/g, eGFR between 25 and 59 mL/min/1.73 m2 and diabetic retinopathy or had a urinary albumin-to-creatinine ratio between 300 and 5000 mg/g with eGFR of 25 to 74 mL/min/1.73 m2 | Composite of kidney failure, a sustained eGFR decrease of at least 40%, or death from renal causes | Cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or heart failure-related hospitalization | 2.6 years |
- Primary endpoint: 18% lower in the finerenone group (hazard ratio, 0.82; 95% CI, 0.73 to 0.93) - Secondary endpoint: 14% lower in the finerenone group (hazard ratio, 0.86; 95% CI, 0.75 to 0.99) |
SGLT2is Sodium/glucose cotransporter-2 inhibitors, eGFR Estimated glomerular filtration rate, DKD Diabetic kidney disease, CKD Chronic kidney disease, HbA1c Hemoglobin A1c