In pediatric nephrotic syndrome, relapse occurred in 14/15 (93%) ACTH recipients versus 15/16 (94%) controls, without a significant difference (OR 0.93, 95% CI 0.05-16.40).
In plain wordsIn pediatric nephrotic syndrome, repository corticotropin did not significantly reduce relapses versus no relapse-preventing treatment.
- Peptide
- ACTH (corticotropin)
- Outcome
- No significant changeRelapse within first 6 months
- Study
n = 31
- Comparator
- No relapse-preventing treatment
- Analysis
- Primary
- Outcome group
- Kidney function · Kidney and urinary
- Studied dose
- 80 U/1.73 m² twice weekly · 6 monthsAs given in this study (human).
Measurements
- Participants with relapse in first 6 months
- 93%
- ACTH arm, 14 of 15
- Participants with relapse in first 6 months
- 94%
- control group, 15 of 16
- Relapse odds ratio
- 0.93 ratio
- 95% CI 0.05 to 16.40; P > 0.99
Source sentences
Fourteen out of 15 (93%) participants in the ACTH arm experienced disease relapse in the first 6 months, with a median time to first relapse of 23 days (interquartile range, 9-32), compared with 15 out of 16 (94%) participants and at a median of 21 days (interquartile range, 14-51) in the control group.
3 context sentences(design, population, supporting numbers)
There was no difference in the proportion of relapsed patients (odds ratio, 0.93; 95% confidence interval, 0.05 to 16.40; P>0.99) or time to first relapse (hazard ratio, 1.03; 95% confidence interval, 0.50 to 2.15; P=0.93).
Participants aged 2-20 years old with frequently relapsing or steroid-dependent nephrotic syndrome were enrolled from 16 sites in the United States and randomized 1:1 to ACTH (repository corticotropin injection) or no relapse-preventing treatment.
ACTH treatment regimen was 80 U/1.73 m2 administered twice weekly for 6 months, followed by 40 U/1.73 m2 administered twice weekly for 6 months.