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Table 2 Demographic characteristics and other reference values

From: Nalfurafine hydrochloride for refractory pruritus in peritoneal dialysis patients: a phase III, multi-institutional, non-controlled, open-label trial

Number of patients   PD patients with pruritus resistant to existing treatments (N = 37)
Sex Male 27 (73.0%)
Female 10 (27.0%)
Age (year)   63.5 ± 9.1
Weight(kg)   63.14 ± 11.03
Primary disease Glomerulonephritis 15 (40.5%)
Diabetic nephropathy 15 (40.5%)
Renal failure, unspecified 1 (2.7%)
Other 6 (16.2%)
Type of dialysis solution Dextrose and icodextrin solutions, or icodextrin solution alone 17 (45.9%)
Dextrose solution 20 (54.1%)
Type of peritoneal dialysis CCPD (with APD) 13 (35.1%)
CAPD (without APD) 24 (64.9%)
Duration of peritoneal dialysis (year)   2.30 ± 2.33
With anamnesis   20 (54.1%)
With complications   37 (100.0%)
Duration of itching (year)   1.76 ± 2.20
Mean VAS score in week 2 in the pretreatment period observation (mm) (the larger of the score upon rising or before bed) 77.22 ± 11.46
Mean itch score based on Shiratori’s severity criteria in week 2 in the pretreatment period observation (the larger of the score upon rising or before bed) 3.11 ± 0.37
Pruritus treatments used within 1 year before the informed consent acquisition date
 Oral drug Antihistamines or antiallergics 37 (100.0%)
Steroid 0 (0.0%)
Other 0 (0.0%)
Total 37 (100.0%)
 Topical product Antihistamines or antiallergics 11 (29.7%)
Steroid 12 (32.4%)
Moisturizing agents 27 (73.0%)
Other 11 (29.7%)
Total 37 (100.0%)
 Injection product Antihistamines or antiallergics 0 (0.0%)
Steroid 0 (0.0%)
Stronger neo-minophagen C 0 (0.0%)
Other 0 (0.0%)
Total 0 (0.0%)
Pruritus treatments used during clinical trial  
 Oral drug Antihistamines or antiallergics 34 (91.9%)
Steroid 0 (0.0%)
Other 0 (0.0%)
Total 34 (91.9%)
 Topical product Antihistamines or antiallergics 7 (18.9%)
Steroid 11 (29.7%)
Moisturizing agents 24 (64.9%)
Other 12 (32.4%)
Total 37 (100.0%)
 Injection product Antihistamines or antiallergics 0 (0.0%)
Steroid 0 (0.0%)
Stronger neo-minophagen C 1 (2.7%)
Other 0 (0.0%)
Total 1 (2.7%)
Pruritus-related factors in CKD patients
 Complications (overlapping) Hyperphosphatemia 28 (75.7%)
Secondary hyperparathyroidism 27 (73.0%)
Asteatosis 3 (8.1%)
Hypocalcemia 1 (2.7%)
Xeroderma 1 (2.7%)
Immunodeficiency 1 (2.7%)
 Laboratory value (pretreatment value) Mean plasma hemoglobin (g/dL; ± SD) 10.58 ± 1.33
Mean plasma eosinophils (%; ± SD) 7.43 ± 6.54
Mean serum albumin (g/dL; ± SD) 3.49 ± 0.40
Mean plasma hematocrit (%; ± SD) 31.98 ± 4.22
Mean serum urea nitrogen (mg/dL; ± SD) 56.2 ± 14.1
Mean serum creatinine (mg/dL; ± SD) 9.953 ± 3.179
Mean serum phosphorus (mg/dL; ± SD) 5.18 ± 1.10
Mean serum calcium (mg/dL; ± SD) 8.85 ± 0.89
  1. Values are the number (percentage) of cases
  2. CCPD continuous cycling peritoneal dialysis, CAPD continuous ambulatory peritoneal dialysis, APD automated peritoneal dialysis, VAS visual analog scale, CKD chronic kidney disease, SD standard deviation