Table 1. Baseline Demographic and Clinical Characteristics.
| Characteristic | Lanreotide (n = 153) |
Control (n = 152) |
|---|---|---|
| Men, No. (%) | 71 (46.4) | 71 (46.7) |
| Women, No. (%) | 82 (53.6) | 81 (53.3) |
| Age, mean (SD), y | 48.2 (7.4) | 48.5 (7.2) |
| Race, No. (%)a | ||
| White | 147 (96.1) | 148 (97.4) |
| Asian | 2 (1.3) | 3 (2.0) |
| Missing | 4 (2.6) | 1 (0.7) |
| PKD genotypeb, No. (%) | ||
| PKD1 truncating | 68 (44.4) | 70 (46.1) |
| PKD1 nontruncating | 37 (24.2) | 41 (27.0) |
| PKD2 | 37 (24.2) | 27 (17.8) |
| No mutation detected | 6 (3.9) | 9 (5.9) |
| Missing | 5 (3.3) | 5 (3.3) |
| Height, mean (SD), m | 1.77 (0.1) | 1.76 (0.1) |
| Weight, mean (SD), kg | 84.5 (16.5) | 83.6 (17.3) |
| BMI, mean (SD) | 26.9 (4.5) | 27.1 (4.8) |
| Blood pressure, mean (SD), mm Hg | ||
| Systolic | 132.3 (12.6) | 133.4 (14.0) |
| Diastolic | 82.3 (9.0) | 82.1 (10.0) |
| Antihypertensive medication, No. (%) | 134 (87.6) | 136 (89.5) |
| RAAS blocker, No. (%) | 124 (81.1) | 126 (82.9) |
| Serum creatinine, mean (SD), mg/dL | 1.46 (0.3) | 1.45 (0.3) |
| eGFRc, mean (SD), mL/min/1.73 m2 | 51.0 (11.5) | 51.4 (11.2) |
| CKD stagesd, No. (%) | ||
| 2 (mild CKD) | 41 (26.8) | 41 (27.0) |
| 3a (mild to moderate CKD) | 55 (35.9) | 62 (40.8) |
| 3b (moderate to severe CKD) | 57 (37.3) | 47 (30.9) |
| 4 (severe CKD) | 0 | 2 (1.3) |
| TKV, mL | 2046 (1383-2964) | 1874 (1245-2868) |
| htTKV, median (IQR), mL/m | 1138 (790-1670) | 1029 (723-1668) |
| ADPKD class, No. (%)e | ||
| 1A/1B (low-risk disease) | 24 (15.7) | 25 (16.4) |
| 1C/1D/1E (high-risk disease) | 119 (77.8) | 120 (78.9) |
| 2 (atypical disease) | 6 (3.9) | 5 (3.3) |
Abbreviations: BMI, body mass index calculated as weight in kilograms divided by height in meters squared; CKD, chronic kidney disease; eGFR, estimated glomerular filtration rate; htTKV, height-adjusted total kidney volume; PKD, polycystic kidney disease; RAAS, renin angiotensin aldosterone system; TKV, total kidney volume.
As determined by the researcher.
Mutation analysis was done by Sanger sequencing and multiplex ligation-dependent probe amplification. No GANAB, HNF1-β, or PKHD1 mutations were detected.
eGFR inclusion criterion for the trial was calculated with creatinine at the screening visit and the modification of diet in renal disease equation, whereas by protocol amendment eGFR results for the trial are calculated for all time points with the CKD-EPI equation.18
Higher CKD stage indicates more impaired kidney function.
Mayo ADPKD classification predicts prognosis, and is based on total kidney volume indexed for height and age. Classes 1C, 1D, and 1E indicate a worse prognosis than classes 1A and 1B. Class 2 is atypical disease, where no prognosis can be assessed.