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Clinical Trials/CTRI/2022/03/041221
CTRI/2022/03/041221
Recruiting
Phase 4

Efficacy of low dose, short course prednisolone regimen for relapse of steroid sensitive nephrotic syndrome in children: A multicenter, randomized, placebo-controlled trial

Pankaj Hari0 sites0 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
Pankaj Hari
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Pankaj Hari

Eligibility Criteria

Inclusion Criteria

  • 1\.Patients with steroid sensitive nephrotic syndrome with at least one relapse in the preceding 12 months, apart from current relapse
  • 2\. Age between 2 and 18 years
  • 3\. In relapse when enrolled, presenting within 3 days of starting therapy
  • 4\. Parents willing to give informed written consent

Exclusion Criteria

  • 1\.Current or past history of steroid resistant nephrotic syndrome
  • 2\.Three or more relapses in the last 12 months
  • 3\. Current relapse on alternate day steroids
  • 4\. Therapy with oral or intravenous cyclophosphamide in the preceding 6 months or intravenous rituximab in the preceding 12 months
  • 5\. Immunosuppression plan likely to be changed in the next 12 months
  • 6\. Presentation with life\-threatening infection (e.g., cellulitis, peritonitis, pneumonia) requiring hospital admission
  • 7\. Secondary nephrotic syndrome (e.g., lupus erythematosus, IgA nephropathy, amyloidosis)
  • 8\. Known chronic infection (tuberculosis, HIV, hepatitis B or C)
  • 9\. Known malignancy
  • 10\. Estimated glomerular filtration rate \<60 ml/min/1\.73 m2

Outcomes

Primary Outcomes

Not specified

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