Table 5.
Select baseline characteristics for PROTECT and other contemporary phase 3 trials with participants with IgAN
| Characteristic | PROTECT |
STOP-IgAN23,24 |
TESTING25,26 |
DAPA-CKD IgAN Patients27,28 |
NefIgArd29,30,a |
||||
|---|---|---|---|---|---|---|---|---|---|
| Total (N = 404) | SC (n = 80) | SC + IST (n = 82) | Methylprednisolone (n = 257) | Placebo (n = 246) | DAPA (n = 137) | Placebo (n = 133) | Nefecon (n = 97) | Placebo (n = 102) | |
| Age, years, mean ± SD or median (IQR) |
46.0 (37.0–56.0) |
45.8 ± 12.5 | 42.8 ± 13.1 | 35.6 (29.4–46.3) |
36.6 (29.0–45.9) |
52.2 ± 13.1 | 50.1 ± 13.1 | 44 (range, 25–69) | 43 (range, 23–73) |
| Sex, % | |||||||||
| Male | 69.8 | 81 | 76 | 60 | 61 | 67.9 | 66.9 | 70.1 | 65.7 |
| Female | 30.2 | 19 | 24 | 40 | 39 | 32.1 | 33.1 | 29.9 | 34.3 |
| Race, % | |||||||||
| White | 67.3 | NR | 100b | 5 | 5 | 39.4 | 40.6 | 87.6 | 84.3 |
| Asian | 28.5 | NR | 0 | 95 | 95 | 59.9 | 57.9 | 11.3 | 12.7 |
| Black or African American | 1.0 | NR | 0 | 0 | 0 | 0 | 0.8 | 0 | 0 |
| Other | 3.2 | NR | 0 | 0 | 0 | 0.7 | 0.8 | 1.0 | 2.9 |
| Systolic BP, mm Hg, mean ± SD or median (IQR) | 129.0 ± 13.5 | 127 ± 8.5 | 124 ± 9.7 | 123.8 (115.0–132.5) |
125.0 (115.5–131.0) |
127.7 ± 16.2 | 127.0 ± 13.9 | 128 (122–134) | 124 (117–131) |
| Diastolic BP, mm Hg, mean ± SD or median (IQR) | 82.4 ± 10.6 | 78 ± 7.0 | 77 ± 7.0 | 80.0 (73.5–85.0) |
80.0 (74.0–86.0) |
78.7 ± 11.8 | 79.5 ± 10.1 | 79 (76–84) | 78 (73–83) |
| BMI, kg/m2, mean ± SD or median (IQR) |
28.4 ± 5.4 | 28.6 ± 5.3 | 27.0 ± 5.0 | 24.2 (21.6–26.7) |
24.7 (22.0–28.0) |
26.3 ± 4.2 | 27.6 ± 6.1 | 29 (26–32) | 28 (24–31) |
| eGFR | |||||||||
| Mean ± SD | 57.0 ± 24.0 | 57.4 ± 24.9 | 61.1 ± 29.0 | NR | NR | 44.3 ± 12.4 | 43.2 ± 12.0 | NR | NR |
| Median (IQR) | 50.0 (39.0–70.0) |
NR | NR | 56.1 (43.2–75.0) |
59.0 (42.0–77.6) |
NR | NR | 54.9 (46.4–68.9) |
55.5 (45.5–67.7) |
| Total protein excretion, g/d mean ± SD or median (IQR) |
1.8 (1.3–2.8) |
1.6 ± 0.7 | 1.8 ± 0.8 | 1.99 (1.36–3.09) |
1.93 (1.38–2.88) |
NR | NR | 2.3 (1.7–3.3) |
2.3 (1.5–3.6) |
| UP/C, g/g, mean ± SD or median (IQR) |
1.2 (0.8–1.8) |
1.0 ± 0.5 | 1.1 ± 0.6 | NR | NR | NR | NR | 1.3 (1.0–1.8) |
1.2 (0.9–1.8) |
| UA/C, g/g, median (IQR) | 1.1 (0.7–1.5) | NR | NR | NR | NR | 0.9 (0.6–1.5) |
0.9 (0.5–1.6) |
1.0 (0.8–1.4) |
1.0 (0.7–1.6) |
| RAASi, %c | |||||||||
| ACEi | 41.6 | 34 | 49 | 54.5 | 52.0 | 32.1 | 30.8 | 55.7 | 43.1 |
| ARB | 52.2 | 30 | 15 | 46.3 | 48.8 | 65.0 | 72.2 | 39.2 | 47.1 |
| ACEi and ARB | 5.9 | 32 | 36 | NR | NR | NR | NR | 3.1 | 6.9 |
| No RAASi | 0.2 | 4 | 0 | 0 | 0 | 0 | 0 | 2.1 | 2.9 |
| % MLD ACEi/ARB, % | |||||||||
| <50% MLD | 2.0 | NR | NR | 11.7 | 14.2 | NR | NR | 22.7 | 19.6 |
| ≥50% MLD | 97.8 | NR | NR | 86.4 | 81.7 | NR | NR | 75.3 | 79.4 |
| ≥50% to 80% MLD | 34.0 | NR | NR | NR | NR | NR | NR | 22.7d | 32.4d |
| >80% MLD | 63.9 | NR | NR | NR | NR | NR | NR | 52.6d | 47.1d |
| 100% MLD | 63.4 | 76.0 | 71.0 | NR | NR | NR | NR | NR | NR |
| ≥1 non-RAASi anti-hypertensives, % | 43.1 | NR | NR | NR | NR | NR | NR | NR | NR |
| Diuretics | 15.4 | NR | NR | 7.8 | 8.5 | 21.2 | 27.1 | 16.5 | 17.6 |
| Calcium-channel blockers | 27.0 | NR | NR | 22.2 | 23.6 | NR | NR | 38.1 | 34.3 |
| Lipid-lowering medication, % | 55.2 | 73 | 81 | NR | NR | 49.6 | 50.4 | 23.7 | 13.7 |
| Kidney biopsy, % | 100 (IC) | 100 (IC) | 100 (IC) | 94.2 (not an IC) |
94.0 (not an IC) |
100 (IC) | |||
| Time since kidney biopsy, mo, median (IQR) | 48 (12–120) | NR | NR | 5 (4–11) | 5 (3–14) | NR | NR | 24 (9.6–73.2) | 33.6 (6.0–85.2) |
ACEi, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; DAPA, dapagliflozin; eGFR, estimated glomerular filtration rate in ml/min per 1.73 m2; IC, inclusion criterion; IQR, interquartile range; IST, immunosuppression treatment; MLD, maximum labeled dose; NR, not reported; RAASi, renin-angiotensin-aldosterone system inhibitors; SC, supportive care with RAS inhibition; UA/C, urine albumin-to-creatinine ratio; UP/C, urine protein-to-creatinine ratio.
Total recruited patients, N = 360. Total patients included in the efficacy analyses of part A, N = 199.
Personal communication from Jurgen Floege, August 2022.
RAASi therapy at baseline was continued during the study in all patient groups in each study except for the PROTECT study.
MLD categories reported as ≥50% and <80% MLD and ≥80% MLD.