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Table 1 Clinical characteristics of study subjects

From: Safety and efficacy of Rapamune® (Sirolimus) in kidney transplant recipients: results of a prospective post-marketing surveillance study in Korea

 

Total (N = 209)

Age, years

47.93 ± 13.10

Age group, n (%)

 < 65 years

183 (87.56)

 ≥ 65 years

26 (12.44)

Sex, male, n (%)

128 (61.24)

Height, cm

164.85 ± 8.80

Body Weight, kg

61.73 ± 10.75

Allergy history, n (%)

5 (2.39)

Secondary transplantation, n (%)

10 (4.78%)

Primary cause of kidney failure, n (%)

 Hypertension

56 (26.79)

 Diabetes mellitus

33 (15.79)

 Glomerulonephritis

55 (26.32)

 Polycystic kidney disease

11 (5.26)

 Others

54 (25.84)

Panel reactive antibody of recipients (%)

 Class I

6.35 ± 21.50

 Class II

5.89 ± 17.39

Type of donation, n (%)

 Living donor

132 (63.46)

 Deceased donor

76 (36.54)

Age of donors, years

41.49 ± 13.16

Past general medical history, n (%)a

141 (67.46%)

Liver disease, n (%)

13 (6.22%)

Concomitant immunosuppressive medication, n (%)b

 Monotherapy

44 (21.05)

 Dual therapy

140 (66.99)

 Triple therapy

25 (11.96)

Trough level of cyclosporine, ng/mL

 Immunoassay

72.84 ± 47.01

 HPLC method

100.18 ± 64.80

Trough level of tacrolimus, ng/mL

 Immunoassay

4.34 ± 1.77

 HPLC method

4.51 ± 3.25

Trough level of mycophenolic acid, ng/mL

 HPLC method

1.53 ± 0.86

Time between transplantation and the first administration of Rapamune, days, median (range)

median 909 (range: 9 to 10,816)

 < 6 months, n (%)

28 (13.40)

 6 months to < 1 year, n (%)

20 (9.57)

 1 year to < 5 years, n (%)

94 (44.98)

 ≥ 5 years, n (%)

65 (31.10)

Total administration period of Rapamune, days

median 182 (range: 4 to 971)

 < 6 months, n (%)

96 (45.93)

 6 month to < 1 year, n (%)

99 (47.37)

 ≥ 1 year, n (%)

14 (6.70)

Daily dose of Rapamune, mg

1.79 ± 0.68

 < 2 mg, n (%)

112 (53.59)

 2 mg, n (%)

46 (22.01)

 > 2 mg, n (%)

51 (24.40)

Trough level of Rapamune, ng/mL

 

 Immunoassay

5.45 ± 2.59

 HPLC method

7.87 ± 4.24

  1. Most numerical values are presented as a mean ± standard deviation, and categorical values are expressed as a frequency (percentage)
  2. Abbreviations: cm centimeter(s), kg kilogram(s), HPLC high performance liquid chromatography
  3. aPast general medical history was defined as any medical illness that had been cured in the past and did not persist at the time of study enrollment
  4. bMonotherapy: steroid only, calcineurin inhibitor only, or anti-metabolite only; Dual therapy: steroid plus calcineurin inhibitor, steroid plus anti-metabolite, or calcineurin inhibitor plus anti-metabolite; Triple therapy: steroid plus calcineurin inhibitor plus anti-metabolite