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.
Investigators
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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