Table 1. Demography and baseline clinical and laboratory characteristics and imaging classification of participants randomized to octreotide-LAR or placebo in the study group considered as a whole (overall) and according to CKD stage 3b and 4.
| Characteristic | Overall | CKD stage 3b | CKD stage 4 | |||
|---|---|---|---|---|---|---|
| Octreotide-LAR (n = 51) |
Placebo (n = 49) |
Octreotide-LAR (n = 20) |
Placebo (n = 17) |
Octreotide-LAR (n = 31) |
Placebo (n = 32) |
|
| Sex (male/female) | 31/20 | 26/23 | 11/9 | 9/8 | 20/11 | 17/15 |
| Age (y) | 48.7 ± 8.9 | 50.0 ± 9.3 | 50.3 ± 9.0 | 48.9 ± 9.1 | 47.7 ± 9.1 | 49.4 ± 8.5 |
| Height (cm) | 172.3 ± 9.8 | 170.7 ± 10.8 | 172.1 ± 11.1 | 174.3 ± 9.7 | 172.1 ± 9.0 | 169.0 ± 11.3 |
| Weight (kg) | 77.2 ± 14.6 | 76.4 ± 14.1 | 74.6 ± 14.6 | 77.7 ± 14.7 | 78.6 ± 14.8 | 75.8 ± 14.0 |
| Blood pressure (mm Hg) | ||||||
| Systolic | 134.9 ± 15.4 | 132.3 ± 13.2 | 137.8 ± 16.8 | 132.2 ± 13.2 | 133.7 ± 14.0 | 132.7 ± 13.4 |
| Diastolic | 81.8 ± 9.3 | 83.1 ± 8.4 | 84.5 ± 8.4 | 84.5 ± 8.7 | 80.9 ± 9.1 | 83.1 ± 7.2 |
| Mean | 99.5 ± 10.3 | 99.5 ± 8.9 | 102.3 ± 11.0 | 100.4 ± 9.7 | 98.5 ± 9.1 | 99.6 ± 7.8 |
| Total cholesterol (mmol/l) | 5.0 ± 1.0 | 4.8 ± 1.0 | 5.3 ± 1.0 | 5.2 ± 1.1 | 4.8 ± 0.9 | 4.7 ± 0.9 |
| LDL cholesterol (mmol/l) | 3.0 ± 0.8 | 2.9 ± 0.9 | 3.2 ± 0.8 | 3.1 ± 0.9 | 2.9 ± 0.8 | 2.8 ± 0.9 |
| Triglycerides (mmol/l) | 1.3 ± 0.7 | 1.3 ± 0.6 | 1.1 ± 0.5 | 1.3 ± 0.8 | 1.5 ± 0.7 | 1.3 ± 0.5 |
| Serum glucose (mmol/l) | 5.0 ± 0.6 | 4.9 ± 0.7 | 4.9 ± 0.6 | 5.0 ± 0.7 | 5.0 ± 0.6 | 4.8 ± 0.7 |
| Serum phosphorus (mmol/l) | 1.2 ± 0.2 | 1.2 ± 0.2 | 1.1 ± 0.2 | 1.2 ± 0.1 | 1.2 ± 0.2 | 1.3 ± 0.2 |
| Serum calcium (mmol/l) | 2.3 ± 0.1 | 2.3 ± 0.2 | 2.3 ± 0.1 | 2.4 ± 0.2 | 2.3 ± 0.1 | 2.3 ± 0.2 |
| Hemoglobin (g/l) | 124 ± 15 | 121 ± 12 | 131 ± 17 | 125 ± 12 | 119 ± 12 | 119 ± 12 |
| Serum albumin (g/l) | 41 ± 4 | 41 ± 4 | 40 ± 4 | 40 ± 5 | 41 ± 5 | 41 ± 4 |
| Serum creatinine (μmol/l) | 229.8 ± 79.6 | 238.7 ± 79.6 | 168.0 ± 26.5 | 168.0 ± 26.5 | 265.2 ± 79.6 | 274.0 ± 70.7 |
| GFR (ml/min/1.73 m2)* | 31.5 [25.6 to 36.6] | 30.9 [21.6 to 37.4] | 36.4 [31.2 to 37.9] | 37.9 [34.2 to 45.6] | 27.8 [24.6 to 34.1] | 26.3 [19.9 to 31.7] |
| eGFR (ml/min/1.73 m2)† | 27.9 [23.5 to 32.2] | 25.8 [19.5 to 33.2] | 33.6 [31.3 to 38.9] | 35.6 [32.3 to 38.4] | 24.6 [20.6 to 27.3] | 21.8 [18.0 to 25.8] |
| Urinary proteins (mg/24 h) | 268 [135 to 805] | 260 [130 to 460] | 180 [130 to 330] | 160 [90 to 300] | 390 [150 to 880] | 320 [180 to 570] |
| Urinary albumin (μg/ml) | 50.7 [21.0 to 118.1] | 28.3[12.8 to 96.2] | 40.8 [31.7 to 129.3] | 21.4 [11.1 to 106.9] | 52.9 [20.9 to 118.1] | 28.3 [12.9 to 61.3] |
| Urinary albumin-to-creatinine ratio (mg/g) | 77.3 [35.9 to 225.9] | 45.4 [25.5 to 181.9] | 66.8 [40.6 to 272.7] | 32.7 [15.7 to 170.6] | 97.2 [35.9 to 192.0] | 51.1 [30.4 to 194.8] |
| TKV (ml) | 2,338 [1,967 to 3,807] | 2,591 [1,959 to 3,835] | 2,006 [1,788 to 2,643] | 2,809 [2,059 to 3,587] | 2,667 [2,026 to 4,060] | 2,567 [1,657 to 4,078] |
| htTKV (ml/m) | 1,344 [1,129 to 2,098] | 1,528 [1,155 to 2,291] | 1,212 [1,088 to 1,497] | 1,614 [1,218 to 1,918] | 1,623 [1,198 to 2,264] | 1,528 [1,082 to 2,534] |
| Imaging classification | ||||||
| 1A | 2 (3.9) | 1 (2.0) | 1 (5.0) | 0 (0.0) | 1 (3.2) | 1 (3.1) |
| 1B | 2 (3.9) | 6 (12.2) | 1 (5.0) | 2 (11.8) | 1 (3.2) | 4 (12.5) |
| 1C | 16 (31.4) | 13 (26.5) | 9 (45.0) | 5 (29.4) | 7 (22.6) | 8 (25.0) |
| 1D | 13 (25.5) | 13 (26.5) | 5 (25.0) | 3 (17.7) | 8 (25.8) | 10 (31.3) |
| 1E | 15 (29.4) | 14 (28.6) | 3 (15.0) | 5 (29.4) | 12 (38.7) | 9 (28.1) |
| Not evaluable | 3 (5.9) | 2 (4.1) | 1 (5.0) | 2 (11.8) | 2 (6.5) | 0 (0.0) |
Data are mean ± SD, median [IQR], or n (percent).
*Measured by iohexol plasma clearance.
†Estimated by the 4-variable equation from Modification of Diet in Renal Disease Study. No difference between treatment groups was significant within the study group considered as a whole, nor in the 2 subgroups of patients with CKD stage 3b or 4 considered separately.
CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; GFR, glomerular filtration rate; htTKV, height-adjusted total kidney volume; octreotide-LAR, octreotide long-acting release; TKV, total kidney volume.