Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Sponsor

Institute of Child Health (Other)

Overall Status

Unknown status

CT.gov ID

NCT00308321

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Parallel group double blind randomised in patients with first episode corticosteroid sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a longer tapering steroid regimen with standard regime

Condition or Disease	Intervention/Treatment	Phase
Nephrotic Syndrome	Drug: long term tapering of prednisolone Drug: standard prednisolone treatment	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Study Start Date :

Sep 1, 2003

Anticipated Study Completion Date :

Oct 1, 2008

Outcome Measures

Primary Outcome Measures

Time to first relapse [5 months]
Assessment of steroid induced morbidity [5 months]

Secondary Outcome Measures

frequent relapsing and steroid dependant disease [5 months]
Time to relapse [5 months]
serious adverse events [5 months]
use of other immunosuppressive agents [5 months]
Achenbach child behaviour checklist [5 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

newly presenting nephrotic syndrome, urine albumin/protein creatinine ratio

200mg/mmol on early morning urine sample, hypoalbuminemia (<25g/L)

Exclusion Criteria:

prior treatment with steroids or cytotoxic agents underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome