Table 1.
Open‐label phase | Randomized phase | ||||
---|---|---|---|---|---|
ZS‐9 10 g (n = 94) | Placebo (n = 26) | ZS‐9 dose | |||
5 g (n = 18) | 10 g (n = 18) | 15 g (n = 25) | |||
Median age, years (range) | 69.0 (36–89) | 69.0 (45–82) | 70.5 (48–89) | 69.0 (46–85) | 68.0 (36–82) |
Sex, n (%) | |||||
Male | 60 (63.8) | 16 (61.5) | 12 (66.7) | 9 (50.0) | 20 (80.0) |
Female | 34 (36.2) | 10 (38.5) | 6 (33.3) | 9 (50.0) | 5 (20.0) |
Race, n (%) | |||||
White | 81 (86.2) | 22 (84.6) | 16 (88.9) | 15 (83.3) | 21 (84.0) |
Black/African American | 12 (12.8) | 3 (11.5) | 2 (11.1) | 3 (16.7) | 4 (16.0) |
Serum potassium, n (%) | |||||
<5.5 mmol/L | 40 (42.6) | 12 (46.2) | 6 (33.3) | 6 (33.3) | 11 (44.0) |
5.5 to <6.0 mmol/L | 42 (44.7) | 10 (38.5) | 11 (61.1) | 9 (50.0) | 11 (44.0) |
≥6.0 mmol/L | 12 (12.8) | 4 (15.4) | 1 (5.6) | 3 (16.7) | 3 (12.0) |
eGFR, n (%) | |||||
<30 mL/min.1.73 m2 | 39 (41.4) | 8 (30.8) | 8 (44.4) | 9 (50.0) | 10 (40) |
<60 mL/min.1.73 m2 | 76 (80.9) | 22 (84.6) | 13 (72.2) | 16 (88.9) | 20 (80.0) |
Comorbidities, n (%)a | |||||
Chronic kidney disease | 71 (75.5) | 19 (73.1) | 12 (66.7) | 15 (83.3) | 18 (72.0) |
Diabetes mellitus | 67 (71.3) | 18 (69.2) | 13 (72.2) | 16 (88.9) | 17 (68.0) |
Heart failure | 94 (100) | 26 (100) | 18 (100) | 18 (100) | 25 (100) |
RAASi medication, n (%) | 65 (69.1) | 21 (80.8) | 11 (61.1) | 14 (77.8) | 14 (56.0) |
ACEi | 41 (43.6) | 18 (69.2) | 5 (27.8) | 7 (38.9) | 11 (44.0) |
ARB | 22 (23.4) | 3 (11.5) | 5 (27.8) | 6 (33.3) | 3 (12.0) |
MRA | 10 (10.6) | 4 (15.4) | 2 (11.1) | 2 (11.1) | 1 (4.0) |
ACE, angiotensin‐converting enzyme; ARB, angiotensin‐receptor blockers; eGFR, estimated glomerular filtration rate; MRA, mineralocorticoid receptor antagonists; RAASi, renin‐angiotensin‐aldosterone system inhibitor.
History of chronic kidney disease or diabetes mellitus collected at study entry.