Table 3. Comparison of All Trial Populations.
| Variable | PREDNOS 2 | Mattoo et al8 | Abeyagunawardena et al,9 2008 | Gulati et al10 | Abeyagunawardena et al,11 2017 |
|---|---|---|---|---|---|
| Recruited sample size | 365 | 36 | 48 (Crossover) | 100 | 48 (Crossover) |
| Completed sample size | 253 | Not reported | 40 | 89 | 33 |
| Age at recruitment, mean (SD), y | 7.7 (3.6) (Prednisolone arm) and 7.5 (3.5) (placebo arm) | 7.2 (Prednisolone arm) and 6.8 (control arm) | Median (range), 5.3 (1.5-13.2) | 6.5 (2.97) (Prednisolone arm) and 6.8 (3.23) (control arm) | 12.3 (Prednisolone arm) and 9.9 (placebo arm) |
| Time from diagnosis to recruitment, mo | 39.7 for intervention and 36.8 for control | Not reported | Not reported | 9.8 for intervention and 10.5 for control | 90 For intervention and 76.8 for control |
| Population definition | ≥2 Relapses in past 12 mo | Low-dose maintenance prednisolone: FRNS (n = 22); after cyclophosphamide (n = 14) | Receiving low-dose maintenance prednisolone | Receiving low-dose maintenance prednisolone | Previous SDNS not receiving any immunosuppression for ≥3 mo |
| Average background prednisolone dose, mg/kg every 48 h | 0.3 (maintenance prednisolone) (n = 165) | 0.5 | 0.36 (range, 0.1-0.6) | 0.6 (0.1) (Prednisolone arm) and 0.7 (0.2) (placebo arm) | Not reported |
| Other background immunosuppression | Other immunosuppression alone: n = 44; low-dose prednisolone plus other immunosuppression: n = 91 | No | No | Levamisole in 32 of 100 patients | No |
| No. of infections (per patient per year) | Mean, 2.95; median, 2 | 3.5a | NA | 3.8b | 3.3c |
| Children excluded because of no URTI | 80 of 333 who completed 12-mo follow-up (24%) | 0 | 3 of 48 (6.3%) | 0 | 0 |
| Total relapses (per patient per year) | 1.67 | 1.93 | Not reported | 1.34 | 0.55 |
| URR frequency in control arm, % of all URTIs | 20.2 | Not reported | 47.5 | 35.0 | 24.8 |
Abbreviations: FRNS, frequently relapsing nephrotic syndrome; NA, not applicable; PREDNOS 2, Prednisolone in Nephrotic Syndrome 2; SDNS, steroid-dependent nephrotic syndrome; URR, URTI-related relapse; URTI, upper respiratory tract infection.
a
Median of 7 URTIs reported during 2 years.
b
A total of 226 episodes of infections reported in the intervention group and 161 in the control group for population of 100.
c
A total of 115 URTIs in the treatment arm and 101 URTIs in the control group with 33 who completed the 2 years of the trial as the denominator.