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Clinical Trials/CTRI/2010/091/001095
CTRI/2010/091/001095
Active, not recruiting
未知

Randomized, double blind, placebo controlled trial to compare the efficacy of 3-months versus 6-months therapy with prednisolone for the first episode of idiopathic nephrotic syndrome in children - None

Indian Council of Medical Research0 sites168 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: null- Initial episode of steroid sensitive nephrotic syndrome
Sponsor
Indian Council of Medical Research
Enrollment
168
Status
Active, not recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

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

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients with idiopathic, steroid sensitive nephrotic syndrome
  • 2\. First episode of nephrotic syndrome
  • 3\. Age 1 to 12 years

Exclusion Criteria

  • 1\.Nephrotic syndrome known to be secondary to a systemic disorder, e.g., IgA nephropathy, systemic lupus erythematosus, Henoch Schonlein purpura, vasculitis, amyloidosis, hepatitis B antigenemia and Alport syndrome.
  • 2\.Patients with impaired renal functions (serum creatinine \> 1\.2 mg/dl, confirmed within 2 weeks)
  • 3\.Patients who have received oral prednisolone, in the past for nephrotic syndrome
  • 4\.Patients who have taken prednisolone in the past 4 weeks, in a dose more than 1 mg/kg for \>10 days for any other reason
  • 5\.Unclear treatment history.
  • 6\.Patients staying more than 100 km from the Institute or those not willing to come for clinic visits every two months
  • 7\.Gross hematuria
  • 8\.Patients with initial steroid resistance
  • 9\.Patients who show relapse within the first 3 months of therapy.

Outcomes

Primary Outcomes

Not specified

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