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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