Table 4.
Ongoing clinical trials of sodium-glucose cotransporter 2 inhibitors in patients with chronic kidney disease
| NCT number (acronym) | Trial drug | Comparator | Eligibility | Primary outcome | Expected study completion date |
|---|---|---|---|---|---|
| NCT03433248 (RACELINES) | Empagliflozin and linagliptin monotherapy or combination therapy | Gliclazide |
1. Patients with T2DM with HbA1c: 7.0—9.5% 2. On treatment with ACE-I or ARB 3. eGFR ≥ 45 mL/min/1.73 m2 |
Changes in fasting and postprandial GFR at Week 16 | December 2020 |
| NCT03036150 (Dapa-CKD) | Dapagliflozin |
1. Patients with T2DM 2. eGFR ≥ 25 and ≤ 75 mL/min/1.73 m2 3. Evidence of increased albuminuria 3 months or more 4. On treatment with ACE-I or ARB |
Time to the first occurrence of any of the components of the composite: (1) ≥ 50% sustained decline in eGFR or (2) reaching ESRD or CV death or renal death | November 2020 | |
| NCT03594110 (EMPA-KIDNEY) | Empagliflozin |
1. Evidence of CKD at risk of kidney disease progression 2. On treatment with ACE-I or ARB |
Composite primary outcome: Time to first occurrence of (1) kidney disease progression or (2) CV death | June 2022 | |
| NCT03315143 (SCORED) | Sotagliflozin |
1. T2DM with HbA1c ≥ 7% 2. eGFR ≥ 25 and ≤ 60 mL/min/1.73 m2 |
Time to the first MACE Time to CV death or HHF |
Marcj 2022 |
ACE-I angiotensin-converting enzyme inhibitor, ARB angiotensin II receptor blocker, CKD chronic kidney disease, CV cardiovascular, eGFR estimated glomerular filtration rate, ESRD end-stage renal disease, GFR glomerular filtration rate, HbA1c glycated hemoglobin, HHF hospitalization for heart failure, T2DM type 2 diabetes mellitus, MACE major adverse cardiac events