Childhood nephrotic syndrome
Conditions
Sponsors
The University of Birmingham
Central Manchester University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children presenting with the first episode of steroid sensitive NS who meet all of the following criteria: • Urine albumin: creatinine ratio > 200mg/mmol or protein:creatinine ratio >200mg/mmol, determined quantitatively on an early morning urine sample. • Serum/plasma albumin level =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Children with histological changes other than minimal lesion glomerulonephritis where renal biopsy has been undertaken • Children with a prior history of poor compliance with medical therapy. • Known allergy to prednisolone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether an extended course of prednisolone reduces the time to first relapse in children presenting with steroid sensitive nephrotic syndrome.;Secondary Objective: To determine whether an extended course of prednisolone i] reduces relapse rate ii] reduces the proportion of children who develop frequently relapsing or steroid dependent disease iii] reduces the requirement for second and third line immunosuppressive agents including levamisole, cyclophosphamide, ciclosporin, tacrolimus and mycophenolate mofetil iv] is associated with an increased incidence of steroid-related adverse events including behavioural problems v] is more cost effective than standard course therapy;Primary end point(s): Time to first relapse. Relapse of proteinuria is defined by Albustix positive proteinuria (+++ or greater) for 3 consecutive days or the presence of generalised oedema plus 3+ proteinuria. | — |
Countries
United Kingdom
Outcome results
None listed