About this trial
This study will compare a short-term course (12 week) glucocorticoid regimen with the Conventional 24-week regimen as originally proposed by KDIGO. The purpose of the study is to determine a short-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive nephrotic syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Urine protein: creatinine ratio ≥3000mg/g (300mg/mmol)
Serum/plasma albumin level < 30g/L
Age ≥ 16 years at the time of diagnosis
No prior therapy with steroids, immunosuppressive or cytotoxic agents for any form of renal disease (other than the 28 days of prednisolone therapy given initially as routine clinical practice)
Disqualifiers
Secondary nephrotic syndrome
Contradictions for glucocorticoids
SRNS: Lack of complete remission within 4 weeks of therapy with daily prednisone or prednisolone at standard dose
anti-PLA2R positive
Trial design
Parallel
Treatments tested in this trial
Conventional 24-week glucocorticoid regimen
DrugWeeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5 - 6: Prednisolone 0.8mg/kg/day (max 60mg); Weeks 7 - 8: Prednisolone 0.6mg/kg/day (max 50mg); Weeks 9 - 10: Prednisolone 0.5mg/kg/day (max 40mg); Weeks 11 - 12: Prednisolone 0.4mg/kg/day (max 30mg); Weeks 13 - 16: Prednisolone 0.3mg/kg/day (max 25mg); Weeks 17 - 20: Prednisolone 0.2mg/kg/day (max 15 Weeks 21 - 24: Prednisolone 0.1mg/kg/day (max 10mg).
short-term course (12 week) glucocorticoid regimen
DrugWeeks 1 - 4, Prednisolone 1mg/kg/day (max 80mg); Weeks 5-8: Prednisolone 1mg/kg/day (max 80mg) on alternate days; 9-12: Prednisolone 0.5mg/kg/day (max 40mg) on alternate days
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Relapse rate
the proportion of adults who develop relapsing
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: