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Original ArticlesGlomerular and Tubulointerstitial Diseases
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Short-Duration Prednisolone in Children with Nephrotic Syndrome Relapse

A Noninferiority Randomized Controlled Trial

Deepika Kainth, Pankaj Hari, Aditi Sinha, Shivam Pandey and Arvind Bagga
CJASN February 2021, 16 (2) 225-232; DOI: https://doi.org/10.2215/CJN.06140420
Deepika Kainth
1Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
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Pankaj Hari
1Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
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Aditi Sinha
1Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
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Shivam Pandey
2Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India
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Arvind Bagga
1Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India
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Abstract

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

  • infrequently relapsing nephrotic syndrome
  • short regimen
  • frequent relapses
  • prednisolone
  • nephrotic syndrome
  • Received April 27, 2020.
  • Accepted December 18, 2020.
  • Copyright © 2021 by the American Society of Nephrology
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Clinical Journal of the American Society of Nephrology: 16 (2)
Clinical Journal of the American Society of Nephrology
Vol. 16, Issue 2
February 08, 2021
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Short-Duration Prednisolone in Children with Nephrotic Syndrome Relapse
Deepika Kainth, Pankaj Hari, Aditi Sinha, Shivam Pandey, Arvind Bagga
CJASN Feb 2021, 16 (2) 225-232; DOI: 10.2215/CJN.06140420

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Short-Duration Prednisolone in Children with Nephrotic Syndrome Relapse
Deepika Kainth, Pankaj Hari, Aditi Sinha, Shivam Pandey, Arvind Bagga
CJASN Feb 2021, 16 (2) 225-232; DOI: 10.2215/CJN.06140420
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Keywords

  • infrequently relapsing nephrotic syndrome
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  • frequent relapses
  • prednisolone
  • nephrotic syndrome

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