Table 2.
Renal parameters, immunoglobulin (Ig)A, IgG and IgM levels, and IgG course, Days-14 to 14
| 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 m2) | (mg/mg) | (g/l) | (ml/min/1.73 m2) | (mg/mg) | (g/l) | (g/l) | (g/l) | (ml/min/1.73 m2) | (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 | 5.4b | 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 |
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.
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.