TABLE 1.
Study | Design and population | Intervention | Effect on eGFR | Effect on UACR |
---|---|---|---|---|
DAPA‐CKD Heerspink et al. 2020 32 |
Phase III, randomized, international trial in patients with CKD with or without T2D (N = 4304) Number (%) of Asians: 1467 (34.0%) |
Dapagliflozin (10 mg); placebo |
Week 2 Dapa: −3.97 ± 0.15 mL/min/1.73 m2 PBO: −0.82 ± 0.15 mL/min/1.73 m2 Annual changes in eGFR from week 2 to month 30 Dapa: −1.67 ± 0.11 mL/min/1.73 m2 per year PBO: −3.59 ± 0.11 mL/min/1.73 m2 per year |
‐ |
DELIGHT Pollock et al. 2019 67 |
Phase II/III, 24‐wk, randomized, international study in patients with DKD (N = 448) Number (%) of Asians: 177 (39.5%) |
Dapagliflozin‐saxagliptin (10/2.5 mg), Dapagliflozin (10 mg), placebo |
Week 1 Dapa: −4.8 (−6.3; −3.3) mL/min per 1.73 m2 Dapa/Saxa: −4.6 (−6.0; −3.1) mL/min/1.73 m2 Week 24 Dapa: −2.4 (−4.2; −0.5) mL/min/1.73 m2 Dapa/Saxa: −2.4 (−4.2; −0.7) mL/min/1.73 m2 |
Week 4 Dapa: −28.3% (−36.8; −18.7) Dapa/Saxa: −34.5% (−42.1; −25.9) Week 24 Dapa: −21.0% (−34.1; −5.2) Dapa/Saxa: −38.0% (−48.2; −25.8) |
CREDENCE Perkovic et al. 2019 31 |
Phase III, randomized, international study, in patients with DKD (N = 4401) Number (%) of Asians: 877 (19.9%) |
Canagliflozin (100 mg); placebo |
Week 3 Cana: −3.72 ± 0.25 mL/min/1.73 m2 PBO: −0.55 ± 0.25 mL/min/1.73 m2 Annual changes in eGFR from week 3 to end of study Cana: −1.85 ± 0.13 mL/min/1.73 m2 per year PBO: −4.59 ± 0.14 mL/min/1.73 m2 per year |
Mean change during follow‐up Cana: −31% (26 to 35%) |
Haneda et al. 2016 60 |
Pooled analysis of four Phase III, 52‐wk studies in Japanese T2D patients with mild or moderate renal impairment (N = 1030) Number (%) of Asians: 1030 (100%); from Japan |
Luseogliflozin (2.5, 5 mg/d) |
Week 52 Normal eGFR (≥90 mL/min/1.73 m2) ≥90 to <100: −0.56 ≥100 to <110: −2.46 ≥110 to <120: −3.15 ≥120: −6.92 Mild renal impairment (≥60 to <90 mL/min/1.73 m2) +0.23 (−0.40 to 0.85) Moderate renal impairment (≥30 to <60 mL/min/1.73 m2) −0.13(−1.05 to 0.78) |
Week 52 Normal eGFR −3.2 mg/g (−8.5 to 2.1) Mild renal impairment +3.5 mg/g (−11.9 to 19.0) Moderate renal impairment −27.4 mg/g (−88.2 to 33.4) |
Ito et al. 2018 61 |
Open‐label, 104‐wk study in Japanese with DKD (N = 50) Number (%) of Asians: 50 (100%); from Japan |
Ipragliflozin (50 mg) |
Baseline 82.1 ± 19.8 mL/min/1.73 m2 Week 24 78.5 ± 17.4 mL/min/1.73 m2 Week 52 82.2 ± 20.7 mL/min/1.73 m2 Week104 81.0 ± 20.2 mL/min/1.73 m2 |
Baseline 15.5 (8.0‐95.7) mg/g Week 24 12.9 (7.4‐36.3) mg/g Week 52 15.2 (8.0‐39.0) mg/g Week 104 14.0 (7.3‐34.6) mg/g |
Jian et al. 2018 62 |
12‐mo study in patients with DKD (N = 126) Number (%) of Asians: 126 (100%); from China |
Dapagliflozin (0.05 g/d) or placebo for 6 mo |
Baseline Dapa: 45.3 ± 12.1 mL/min/1.73 m2 PBO: 42.3 ± 10.3 mL/min/1.73 m2 3 months Dapa: 52.3 ± 12.2 mL/min/1.73 m2 PBO: 51.2 ± 9.8 mL/min/1.73 m2 6 months Dapa: 55.3 ± 18.5 mL/min/1.73 m2 PBO: 45.3 ± 9.4 mL/min/1.73 m2 12 months Dapa: 64.4 ± 12.5 mL/min/1.73 m2 PBO: 54.3 ± 10.7 mL/min/1.73 m2 |
|
Kashiwagi et al. 2015 63 |
24‐wk, randomized, double‐blind study followed by open‐label 52‐wk extension in Japanese patients with DKD (N = 165) Number (%) of Asians: 165 (100%); from Japan |
Ipragliflozin (50 mg) |
All patients Week 2 Ipra: −2.8 ± 4.78 mL/min/1.73 m2 PBO: +0.1 ± 4.34 mL/min/1.73 m2 Week 4 Ipra: −2.0 ± 5.77 mL/min/1.73 m2 PBO: +1.4 ± 5.35 mL/min/1.73 m2 Week 12 Ipra: −1.4 ± 5.85 mL/min/1.73 m2 PBO: +0.5 ± 5.60 mL/min/1.73 m2 Week 24 Ipra: +0.2 ± 6.56 mL/min/1.73 m2 PBO: +1.5 ± 6.00 mL/min/1.73 m2 Mild renal impairment Week 2 Ipra: −3.3 ± 5.07 mL/min/1.73 m2 PBO: −0.1 ± 4.92 mL/min/1.73 m2 Week 4 Ipra: −1.4 ± 5.99 mL/min/1.73 m2 PBO: +2.4 ± 6.19 mL/min/1.73 m2 Week 12 Ipra: −1.7 ± 6.39 mL/min/1.73 m2 PBO: −0.8 ± 6.80 mL/min/1.73 m2 Week 24 Ipra: +0.9 ± 7.57 mL/min/1.73 m2 PBO: +1.4 ± 6.84 mL/min/1.73 m2 Moderate renal impairment Week 2 Ipra: −2.4 ± 4.47 mL/min/1.73 m2 PBO: +0.3 ± 3.76 mL/min/1.73 m2 Week 4 Ipra: −2.5 ± 5.53 mL/min/1.73 m2 PBO: +0.3 ± 4.12 mL/min/1.73 m2 Week 12 Ipra: −1.2 ± 5.30 mL/min/1.73 m2 PBO: +1.9 ± 3.65 mL/min/1.73 m2 Week 24 Ipra: −0.4 ± 5.29 mL/min/1.73 m2 PBO: +1.6 ± 5.18 mL/min/1.73 m2 Week 52 +0.2 ± 6.56 mL/min/1.73 m2 |
All patients Week 2 Ipra: −35.64 ± 170.28 mg/g PBO: −2.03 ± 108.58 mg/g Week 24 Ipra: −23.72 ± 229.10 mg/g PBO: +4.28 ± 62.64 mg/g Mild renal impairment Week 2 Ipra: −19.83 ± 68.48 mg/g PBO: +3.21 ± 52.28 mg/g Week 24 Ipra: −10.79 ± 168.70 mg/g PBO: −9.51 ± 29.51 mg/g Moderate renal impairment Week 2 Ipra: −51.99 ± 232.66 mg/g PBO: −7.28 ± 146.02 mg/g Week 24 Ipra: −37.10 ± 279.14 mg/g PBO: +18.08 ± 82.19 mg/g Week 52 −23.72 ± 229.10 mg/g |
Osonoi et al. 2018 64 |
Open‐label, 12‐wk study in Japanese T2D with microalbuminuria (N = 20) Number (%) of Asians: 20 (100%); from Japan |
Canagliflozin (100 mg) |
Week 12 −8.9 ± 7.5 (−12.4 to −5.3) mL/min/1.73 m2 |
Week 12 −19 mg/g % change from baseline (95% CI): 22% (−41.7 to 4.1) |
Sugiyama et al. 2019 65 |
1‐y study of Japanese with DKD (N = 42) Number (%) of Asians: 42 (100%); from Japan |
SGLT‐2 inhibitor therapy |
1 year +0.3 (−0.9 to 2.7) mL/min/1.73 m2 Annual changes in eGFR (mL/min/1.73 m2 per year) Before SGLT‐2 inhibitor therapy: −3.8 (−6.0 to −1.7) After SGLT‐2 inhibitor therapy: +0.1 (−0.8 to +1.5) |
1 year −0.13 (−0.72 to −0.10) g/g |
Takashima et al. 2018 66 |
52‐wk, randomized, open‐label study in patients with DKD (N = 42) Number (%) of Asians: 42 (100%); from Japan |
Canagliflozin (100 mg) |
Week 52 Cana: +0.7 ± 6.4 mL/min/1.73 m2 PBO: −3.4 ± 4.5 mL/min/1.73 m2 |
Week 52 Cana: −83 (−266 to −31) mg/g PBO: +27 (−11 to +131) mg/g |
Abbreviations: Cana, canagliflozin; Dapa, dapagliflozin; DKD, diabetic kidney disease; eGFR, estimated glomerular filtration rate; Empa, empagliflozin; Ipra, ipragliflozin; Saxa, saxagliptin; SGLT‐2, sodium‐glucose co‐transporter‐2; PBO, placebo; T2D, type 2 diabetes.