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Short-Duration Prednisolone in Children with Nephrotic Syndrome Relapse: A Noninferiority Randomized Controlled Trial
Deepika Kainth1, Pankaj Hari1, Aditi Sinha1
1Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
Insights
A short steroid regimen for nephrotic syndrome relapses in children showed similar outcomes to standard treatment but did not establish noninferiority. This approach reduced cumulative steroid exposure, offering a potential benefit for managing frequent relapses.
Area of Science:
- Pediatric Nephrology
- Clinical Pharmacology
- Evidence-Based Medicine
Background:
- Steroids are essential for treating relapses in childhood nephrotic syndrome.
- Optimal steroid duration and dosage, particularly for infrequent relapsers, remain under-researched.
- This study addresses the need for evidence on abbreviated steroid regimens.
Purpose of the Study:
- To evaluate the efficacy of a short-course prednisolone regimen compared to a standard regimen in children with infrequently relapsing nephrotic syndrome.
- To determine if a shorter steroid treatment duration can achieve comparable outcomes to standard treatment without increasing relapse frequency or steroid dependence.
Main Methods:
- A single-center, open-label, randomized controlled trial involving 117 children (aged 1-16 years) with nephrotic syndrome.
- Patients were randomized to receive either a short regimen (40 mg/m² alternate days for 2 weeks) or a standard regimen (40 mg/m² alternate days for 4 weeks) after achieving remission.
- The primary outcome measured was the proportion of children experiencing frequent relapses or steroid dependence at 12 months.
Main Results:
- No significant difference was observed in the proportion of children developing frequent relapses or steroid dependence between the short (23%) and standard (24%) regimens (Risk Difference: -1%; 95% CI: -15 to 16; P=0.90).
- Time-to-event analysis also showed no significant difference between groups (Hazard Ratio: 1.01; 95% CI: 0.83 to 1.23; P=0.98).
- The short regimen resulted in significantly lower cumulative steroid exposure (Risk Difference: -541 mg/m²; P<0.001) with similar relapse rates and adverse events.
Conclusions:
- A short steroid treatment regimen for relapses in children with infrequently relapsing nephrotic syndrome led to similar rates of frequent relapses or steroid dependence compared to the standard regimen.
- However, the study did not establish noninferiority for the short regimen due to a wide confidence interval.
- The abbreviated regimen significantly reduced cumulative steroid exposure, suggesting a potential benefit in minimizing steroid-related side effects.
Background And Objectives:
In children with nephrotic syndrome, steroids are the cornerstone of therapy for relapse. The adequate duration and dosage of steroids, however, have not been an active area of research, especially in children with infrequently relapsing nephrotic syndrome. This study investigated the efficacy of an abbreviated regimen for treatment of a relapse in this population.
Design, Setting, Participants, & Measurements:
In a single-center, open-label, randomized controlled trial, we evaluated the efficacy of prednisolone as a "short regimen" (40 mg/m2 on alternate days for 2 weeks) compared with "standard regimen" (40 mg/m2 on alternate days for 4 weeks) for children aged 1-16 years who achieved remission of a relapse. The primary outcome was the proportion of children developing frequent relapses or steroid dependence at 12 months.
Results:
A total of 117 patients were enrolled and randomized to short (55) or standard (62) regimen. Fourteen (24%) patients in standard regimen and 12 (23%) in short regimen developed frequent relapses or steroid dependence over a period of 1 year (risk difference, -1%; 95% confidence interval, -15 to 16; P=0.90). A large 95% confidence interval crossed the proposed noninferiority margin. In a time to event analysis, there was no significant difference in the proportion of children developing frequent relapses or steroid dependence and time to outcome between the two groups (hazard ratio, 1.01; 95% confidence interval, 0.83 to 1.23; P=0.98). Time to relapse, relapse rate, and steroid-related adverse events were similar in both groups. Cumulative steroid exposure was significantly lower in the short regimen (risk difference, -541 mg/m2; 95% confidence interval, -917 to -164 mg/m2; P<0.001).
Conclusions:
In children with infrequently relapsing nephrotic syndrome, a short steroid treatment for relapse resulted in a similar proportion of patients developing frequent relapses or steroid dependence; however, noninferiority of a short regimen was not established.
Clinical Trial Registry Name And Registration Number:
CTRI/2015/11/006345.
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