Table 1.

Subject disposition, demographics, and baseline clinical characteristics

ParameterPrior Trial ParticipationTotal
From Replicating Evidence of Preserved Renal Function: An Investigation of Tolvaptan Safety and Efficacy in Autosomal Dominant Polycystic Kidney Disease TolvaptanFrom Replicating Evidence of Preserved Renal Function: An Investigation of Tolvaptan Safety and Efficacy in Autosomal Dominant Polycystic Kidney Disease PlaceboFrom Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes 4:4 Tolvaptan
Disposition
 Enrolled506570718a1803b
 Completed4344236241488
 Discontinued7214795316
Demographics
 Age, yr
  Mean (SD)49 (8)49 (8)46 (8)47 (8)
 Sex
  Men272 (54%)280 (49%)375 (52%)929 (52%)
  Women234 (46%)290 (51%)343 (48%)874 (48%)
 Height, cm
  Mean (SD)174 (11)173 (10)175 (11)174 (11)
 Weight, kg
  Mean (SD)86 (19)84 (21)82 (19)84 (19)
 Race
  White461 (91%)525 (92%)694 (97%)1689 (94%)
Baseline clinical characteristics
 CKD stage
  CKD 11 (0.2%)0 (0.0%)77 (11%)81 (4%)
  CKD 235 (7%)33 (6%)264 (37%)334 (19%)
  CKD 3a131 (26%)146 (26%)156 (22%)434 (24%)
  CKD 3b189 (37%)230 (40%)132 (18%)554 (31%)
  CKD 4150 (30%)158 (28%)82 (11%)390 (22%)
  CKD 50 (0.0%)3 (0.5%)7 (1.0%)10 (0.6%)
 eGFR (CKD-EPI), ml/min per 1.73 m2
  >45167 (33%)179 (31%)497 (69%)849 (47%)
  ≤45339 (67%)391 (69%)221 (31%)954 (53%)
  ≥25429 (85%)486 (85%)662 (92%)1586 (88%)
  <2577 (15%)84 (15%)56 (8%)217 (12%)
  • CKD stages were from the time of entry into this trial, and they were defined as follows: stage 1≥90 ml/min per 1.73 m2, stage 2=60–89 ml/min per 1.73 m2, stage 3a=45–59 ml/min per 1.73 m2, stage 3b=30–44 ml/min per 1.73 m2, stage 4=15–29 ml/min per 1.73 m2, and stage 5<15 ml/min per 1.73 m2. CKD-EPI, Chronic Kidney Disease Epidemiology Collaboration.

  • a The number of subjects enrolling from the Tolvaptan Efficacy and Safety in Management of Autosomal Dominant Polycystic Kidney Disease and Its Outcomes (TEMPO) 4:4 (n=718) trial is one less than the number who completed or discontinued (n=719) due to one subject with missing data that resulted in exclusion from the enrolled population.

  • b The table has no column for subjects who entered the extension directly from TEMPO 3:4 or NOCTURNE due to the small number of subjects (n=9; four from TEMPO 3:4 tolvaptan, two from NOCTURNE tolvaptan, and three from TEMPO 3:4 placebo) from those trials. Data from these subjects are included in the total column.