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Table 2 Renal parameters, immunoglobulin (Ig)A, IgG and IgM levels, and IgG course, Days-14 to 14

From: Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial

Patient

#

Screening day

(Day -14)*

Day 1

Day 14

 

GFR

UPr:Cr

IgG

GFR

UPr:Cr

IgA

IgM

IgG

IgG change

from Day -14

GFR

UPr:Cr

IgA

IgM

IgG

IgG change

from Day 1

 

(ml/min/1.73 m 2 )

(mg/mg)

(g/l)

(ml/min/1.73 m 2 )

(mg/mg)

(g/l)

(g/l)

(g/l)

 

(ml/min/1.73 m 2 )

(mg/mg)

(g/l)

(g/l)

(g/l)

(%)

2

73.5L

1.6

16.3

68.4L

0.2

1.9

1.0

16.3

0

45.3L1, a

0.1a

2.0a

0.8a

15.1a

-7.4

8

78.7

2.3

14.2

76.3

N/A

2.9

0.3L

13.9

-2.1

88.8a

0.8a

2.7a

0.3L, a

11.1a

-20.1

3

73.4L

8.2

16.3

81.6

5.6

4.5

1.2

13.0

-20.3

72.2L

8.1a

2.3a

0.7a

6.5a

-49.7

5

74.5L

3.0

20.1

89.0

1.0

6.3

1.2

14.3

-28.9

69.7L, b

7.1

5.4 b

1.1b

10.9b

-23.8

13

33.6L2

4.6

11.3

30.9L2

12.4

1.1

0.3L

4.9L

-56.9

34.1L2, a

8.4a

0.6L, a

< 0.2L

3.6L, a

-25.5

14

26.9c,†, L2

12.0

9.1

24.4L2

18.0

< 0.3L

< 0.2L

4.8L

-47.1

38.8L2, d

9.0d

0.5L, d

0.6d

2.5L, d

-47.4

  1. Patients #2 and #8 randomized to placebo; Patients #3, #5, #13 and #14 randomized to atacicept 150 mg subcutaneously twice weekly (4 weeks), then 150 mg weekly (48 weeks). *IgA and IgM levels not recorded at screening; GFR, glomerular filtration rate; Ig, immunoglobulin; UPr:Cr, urine protein:creatinine ratio.
  2. Values > ULN indicated in italics; LValues < LLN with (Grade 1 to 4), where applicable; Ig reference ranges: IgA, 0.7 to 4.0 g/l; IgM, 0.4 to 2.3 g/l; IgG, 5.7 to 17.6 g/l. aMeasured Day 15; bMeasured Day 13; cMeasured Day -18; dMeasured Day 18. †GFR > 30 ml/min/1.73 m2 on repeat testing.