Table 1.
Characteristics | CKD Stage 1 (n=502) | CKD Stage 2 (n=689) | CKD Stage 3 (n=248) | |||
---|---|---|---|---|---|---|
Tolvaptan (n=330) | Placebo (n=172) | Tolvaptan (n=465) | Placebo (n=224) | Tolvaptan (n=163) | Placebo (n=85) | |
Men, % | 47.3 | 47.4 | 49.7 | 52.2 | 65.6 | 58.8 |
Age, yr | 34±7 | 35±8 | 40±6 | 41±6 | 42±6 | 42±6 |
Race, % | ||||||
White | 91 | 94 | 82 | 80 | 78 | 75 |
Asian | 7 | 4 | 15 | 17 | 17 | 20 |
Other | 2 | 2 | 3 | 3 | 5 | 5 |
Height, cm | 174±10 | 173±10 | 173±11 | 173±10 | 176±10 | 176±9 |
Weight, kg | 78±19 | 77±19 | 78±18 | 77±18 | 86±17 | 85±17 |
BP, mmHg | ||||||
Systolic | 128±13 | 129±13 | 129±14 | 128±14 | 129±14 | 128±13 |
Diastolic | 82±9 | 82±9 | 83±10 | 82±10 | 83±11 | 83±9 |
History of hypertension, % | 73 | 71 | 84 | 90 | 95 | 93 |
Treatment with ACEIs or ARBs, % | 73 | 69 | 84 | 88 | 95 | 93 |
History of kidney pain, % | 56 | 51 | 48 | 50 | 53 | 42 |
History of proteinuria, % | 19 | 20 | 26 | 25 | 30 | 31 |
Estimated CrCl <80 ml/min, % | 2 | 2 | 25 | 28 | 66 | 71 |
TKV, ml | 1375±681 | 1313±529 | 1713±861 | 1713±823 | 2353±1101 | 2266±1174 |
Serum creatinine, mg/dl | 0.82(0.14) | 0.80±0.15 | 1.06±0.18 | 1.07±0.18 | 1.51(0.27) | 1.48±0.35 |
Fasting urine osmolality, mOsm/kg | 572±180 | 592±197 | 483±165 | 491±154 | 413±119 | 444±199 |
eGFR, ml/min per 1.73 m2 | 105±10 | 107±13 | 75±9 | 75±9 | 51±6 | 52±8 |
Urinary ACR (mg/g)a | 24.0 (13.0–47.0) | 24.0 (14.7–53.0) | 28.3 (15.9–64.7) | 29.8 (14.0–56.1) | 37.5 (19.0–90.6) | 42.1 (21.0–113.7) |
Values expressed with a plus/minus sign are the mean±SD. ACEI, angiotensin-converting enzyme inhibitor; ARB, angiotensin-receptor blocker; CrCl, creatinine clearance; TKV, total kidney volume; ACR, albumin-to-creatinine ratio.
Expressed as median (interquartile range).