Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Institute of Child Health

Status and phase: Unknown; Phase 4

Conditions: Nephrotic Syndrome

Treatments: Drug: long term tapering of prednisolone; Drug: standard prednisolone treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00308321

03NU13

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind